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Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol

Por: Chabanne · R. · Fernandez-Canal · C. · Degos · V. · Lukaszewicz · A.-C. · Velly · L. · Mrozek · S. · Perrigault · P.-F. · Molliex · S. · Tavernier · B. · Dahyot-Fizelier · C. · Verdonk · F. · Caumon · E. · Masgrau · A. · Begard · M. · Chabert · E. · Ferrier · A. · Jaber · S. · Bazin · J.-
Introduction

Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.

Methods and analysis

Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0–2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.

Ethics and dissemination

The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.

Trial registration number

NCT03229148.

Analgesic efficacy and safety of ketamine after total knee or hip arthroplasty: a meta-analysis of randomised placebo-controlled studies

Por: Xu · B. · Wang · Y. · Zeng · C. · Wei · J. · Li · J. · Wu · Z. · He · H. · Lei · G. · Xie · D. · Ding · X.
Objective

To examine the analgesic efficacy and safety of ketamine after total knee or hip arthroplasty.

Design

Systematic review and meta-analysis.

Data sources

PubMed, EMBASE and Cochrane Library from inception to 22 May 2019.

Eligibility criteria for selecting studies

Randomised controlled trials comparing the efficacy and safety of ketamine with placebo for postoperative pain relief in patients undergoing total knee or hip arthroplasty.

Data extraction and synthesis

Data (ie, pain intensity, morphine consumption, gastrointestinal and psychotic adverse effects) were extracted by two reviewers independently. The Cochrane Collaboration’s recommended tool was used to determine the methodological quality of included studies.

Results

A total of 10 studies were included. One of them was rated as low quality. Compared with placebo, intravenous ketamine was effective for pain relief during 0–8-hour (weighted mean difference (WMD) –1.21, 95% CI –1.45 to –0.98, p

Conclusions

Intravenous administration of ketamine is effective and safe for postoperative pain relief in patients undergoing total knee or hip arthroplasty. Nevertheless, the analgesic efficacy and safety of ketamine in such patients seem to vary by different administration routes and still warrant further studies to explore.

The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study

Por: Corcoran · T. B. · Myles · P. S. · Forbes · A. B. · O'Loughlin · E. · Leslie · K. · Story · D. · Short · T. G. · Chan · M. T. · Coutts · P. · Sidhu · J. · Cheng · A. C. · Bach · L. A. · Ho · K. M. · on behalf of the Australian and New Zealand College of Anaesthetists Clinical Tri
Introduction

The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.

Methods/analysis

This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.

Ethics/dissemination

The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.

Trial registration number

ACTRN12614001226695.

Subcutaneous sumatriptan for the treatment of postcraniotomy pain (SUPS trial): protocol for a randomised double-blinded placebo controlled trial

Por: Licina · A. · Russell · J. · Silvers · A. · Jin · X. · Denny · J.
Introduction

Postcraniotomy pain protocols use opioids, which are considered suboptimal analgesia following this procedure. Multimodal analgesia components are sparse. Our null hypothesis states that sumatriptan is not different to placebo in addition to usual intravenous opioids, for the treatment of acute postcraniotomy pain.

Methods and analysis

This is a prospective single-centre randomised double-blinded placebo-controlled phase III clinical trial comparing subcutaneous sumatriptan injection in the recovery area with placebo for the treatment of postcraniotomy pain. Eligible adult patients (18 years and older) undergoing craniotomy will be identified preoperatively. Both patient groups will receive a subcutaneous injection at a point where recovery-nursing staff would initiate the usual intravenous opioid analgesia as per standardised pain management protocol. In both groups, further pain management will be followed by the usual intravenous opioid administration. Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration. Postcraniotomy pain will be measured at regular intervals using the Visual Analogue Scale (VAS) in recovery area. The minimal clinically important difference of 10 mm on the VAS between the two groups will be considered as statistically significant. We will include selected clinical and patient-reported outcomes as secondary endpoints. Univariate regression will be conducted on each one of the clinically plausible potential confounders. We will enrol a total 136 patients, with the study duration of 2 years. This trial will commence recruitment on the 1 July 2019.

Ethics and dissemination

This trial protocol has achieved approval by the Austin Health Research Committee, HREC/17/Austin/596. This trial was prospectively registered with Australian New Zealand Clinical Trials Registry on the 10/05/2018 with a unique trial identifier U1111-1209-9072 and registration Number ACTRN12618000793213P. Findings of this study will be disseminated in peer-reviewed academic journals.

Trial registration number

U1111-1209-9072, ACTRN12618000793213P

Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial

Por: Darvall · J. · von Ungern-Sternberg · B. S. · Braat · S. · Story · D. · Davidson · A. · Allen · M. · Tran-Duy · A. · Middleton · D. · Leslie · K.
Introduction

Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year.

Methods and analysis

This is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration.

Ethics and dissemination

The Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature.

Trial registration number

ACTRN12618000429257; Pre-results.

Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial

Por: Huang · B. · Huang · Q. · Hai · C. · Zheng · Z. · Li · Y. · Zhang · Z.
Introduction

Effectively preventing or treating spinal-induced maternal hypotension is considered to be the Holy Grail of obstetric anaesthesia. Prophylactic fluid preloading and vasopressors decrease hypotension but may aggravate heart load, induce fetal acidosis or maternal bradycardia. Using low-dose local anaesthetic decreases hypotension but may cause insufficient anaesthesia. Whether there is a height-based dosing algorithm of local anaesthetic in spinal anaesthesia for caesarean section that can provide sufficient anaesthesia with less hypotension without prophylactic fluid preloading and vasopressors is unclear. This study was designed to investigate a height-based dosing algorithm of bupivacaine in spinal anaesthesia for caesarean section.

Methods and analysis

This single-centre, double-blinded, prospective, non-inferiority, randomised controlled trial will include 264 parturients (between 18 and 45 years of age) who are scheduled for caesarean section. All participants will not receive prophylactic fluid preloading. The participants will be randomly divided into two groups: the test group or conventional group. For parturients in the test group, 0.5% isobaric bupivacaine (1.15–1.70 mL) will be injected into the subarachnoid space without prophylactic vasopressors. The bupivacaine dose depends on the height of subjects. For parturients in the conventional group, 0.5% bupivacaine (1.8 mL) will be injected into the subarachnoid space along with prophylactic vasopressors. The primary outcome is the incidence of maternal hypotension. The secondary outcomes include the failure rate of spinal anaesthesia, level of sensory block, degree of motor block, other complications in parturients, time of operation, neonatal outcome and quality of anaesthesia.

Ethics and dissemination

This study was approved by the Ethics Committee of Shenzhen People’s Hospital of Jinan University (Permit No. SZY-00251, chairperson Xiaofang Yu) on 8 February 2018The study results will be disseminated through peer-reviewed journals, professional societies and meetings.

Trial registration number

NCT03497364; Pre-results.

PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial

Por: Yau · D. K. W. · Wong · M. K. H. · Wong · W.-T. · Gin · T. · Underwood · M. J. · Joynt · G. M. · Lee · A.
Introduction

Frailty is a multidimensional syndrome in which multiple small physiological deficits accumulate gradually, resulting in a loss of physiological reserve and adaptability, putting a patient that is exposed to a stressor at a higher risk of adverse outcomes. Both pre-frailty and frailty are associated with poor patient outcomes and higher healthcare costs. The effect of a prehabilitation programme and standard care on the quality of recovery in pre-frail and frail patients undergoing elective cardiac surgery will be compared.

Method and analysis

A single-centre, superiority, stratified randomised controlled trial with a blinded outcome assessment and intention-to-treat analysis. Pre-frail and frail patients awaiting elective coronary artery bypass graft, with or without valvular repair/replacement, will be recruited. 164 participants will be randomly assigned to either prehabilitation (intervention) or standard care (no intervention) groups. The prehabilitation group will attend two sessions/week of structured exercise (aerobic and resistance) training, supervised by a physiotherapist, for 6–10 weeks before surgery with early health promotion advice in addition to standard care. The standard care group will receive the usual routine care (no prehabilitation). Frailty will be assessed at baseline, hospital admission and at 1 and 3 months after surgery. The primary outcomes will be participants' perceived quality of recovery (15-item Quality of Recovery questionnaire) after surgery (day 3), days at home within 30 days of surgery and the changes in WHO Disability Assessment Schedule 2.0 score between baseline and at 1 and 3 months after surgery. Secondary outcomes will include major adverse cardiac and cerebrovascular events, psychological distress levels, health-related quality of life and healthcare costs.

Ethics and dissemination

The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No. 2017.696 T). The findings will be presented at scientific meetings, in peer-reviewed journals and to study participants.

Trial registration number

ChiCTR1800016098; Pre-results.

Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study

Por: Vourch · M. · Huard · D. · Feuillet · F. · Baud · G. · Guichoux · A. · Surbled · M. · Tissot · M. · Chiffoleau · A. · Guitton · C. · Jaber · S. · Asehnoune · K.
Introduction

Although preoxygenation and airway management respond to precise algorithms, difficult intubation (DI) remains a daily challenge in intensive care units and in the operating rooms because of its frequent complications, including hypoxaemia. To prevent desaturation during DI, high-flow oxygenation by nasal cannula (HFNC) could prove beneficial. Indeed, contrary to standard preoxygenation device, it can be held in place throughout the intubation trying to perform apnoeic oxygenation during DI. Hence, recent guidelines recommend HFNC during DI, but its relevance has never been evaluated in this setting in a large randomised study until now.

Methods and analysis

The PREOPTIDAM trial is a prospective, single-centre, randomised, controlled study in Nantes University Hospital. In anticipated DI, we hypothesised that HFNC can decrease the incidence of desaturation ≤94% or face mask ventilation from 16% to 4% compared with standard device. Using a two-sided t-test with a first species risk of 5% and 80% power, a total of 186 patients will be included. Using a computer-generated randomisation, with a 1:1 allocation ratio, patients will be randomised to HFNC or face mask preoxygenation. Randomisation will be stratified on intubation sequence: Rapid sequence intubation or awake fibreoptic intubation. The primary objective is to determine whether HFNC is more efficient than standard oxygenation techniques to prevent desaturation ≤94% or face mask ventilation during DI. Intent-to-treat and per-protocol analysis are planned for the primary outcome.

Ethics and dissemination

The study project has been approved by an independent ethics committee. Written informed consent will be obtained before study inclusion. Participant recruitment begins in September 2018. Results will be submitted to international peer-reviewed medical journals.

Trial registration number

NCT03604120.

Effects of esmolol on QTc interval changes during tracheal intubation: a systematic review

Por: Thiruvenkatarajan · V. · Lee · J. Y. · Sembu · M. · Watts · R. · Van Wijk · R. M.
Introduction and aims

Esmolol is an ultra-short-acting β1 antagonist that has been shown to attenuate the corrected QT (QTc) interval prolongation associated with laryngoscopy and endotracheal intubation (LTI). Prolongation of the QTc interval can precipitate arrhythmias, the most serious of which is torsades de pointes . The aim of this systematic review was to compare esmolol and placebo on QTc changes occurring during LTI.

Materials and methods

PubMed, EMBASE, Cochrane Registry of Clinical Trials and CINAHL databases (up to August 2018) were screened for randomised controlled trials comparing esmolol and placebo on QTc changes during LTI in cardiac and non-cardiac surgeries. The primary outcome was QTc changes during LTI and secondary outcome was related to adverse effects from esmolol such as bradycardia and hypotension.

Results

Seven trials were identified involving 320 patients, 160 patients receiving esmolol or placebo apiece. A shortening of the QTc post-LTI was evident in the esmolol group compared with the placebo in four studies. Compared with the baseline, the QTc was reduced post-LTI in the esmolol group. In the placebo group, the QTc was prolonged compared with the baseline post LTI. Nonetheless, esmolol did not prevent QTc prolongation in the remaining three studies, and much of this was attributed to employing QTc prolonging agents for premedication and anaesthetic induction. No significant adverse events were noted.

Conclusion

Compared with placebo, esmolol reduced the LTI-induced QTc prolongation when current non-QTc prolonging agents were chosen for tracheal intubation. Future studies should explore whether transmural dispersion (a marker of torsadogenicity) is also affected during LTI by analysing parameters such as the Tp-e interval (interval between the peak to the end of the T-wave) and Tp-e/QTc (rate corrected Tp-e interval).

Trial registration number

CRD42018090282.

Training non-physician anaesthetists in sub-Saharan Africa: a qualitative investigation of providers perspectives

Por: Edgcombe · H. · Baxter · L. S. · Kudsk-Iversen · S. · Thwaites · V. · Bulamba · F.
Objectives

To explore the views of non-physician anaesthesia providers (NPAPs) and their colleagues regarding the effectiveness of NPAP training programmes in three contrasting sub-Saharan African countries.

Design

This was a qualitative exploratory descriptive study. Semistructured interviews were conducted online, recorded, transcribed and analysed thematically using NVivo.

Setting

Participants’ homes or workplaces in Sierra Leone, Somaliland and Uganda.

Participants

15 NPAPs, physician anaesthetists and surgeons working in the countries concerned.

Results

Three major themes were identified: (1) discrepancy between urban training and rural practice, (2) prominent development of attitudes outside the curricular set during training, including approaches to learning and clinical responsibility and (3) the importance of interprofessional relationships developed during training for later practice.

Conclusions

Anaesthesia providers in different cadres and very different country contexts in sub-Saharan Africa describe common themes in training which appear to be significant for their later practice. Not all these issues are explicitly planned for in current training programmes, although they are important in the view of providers. Subsequent programme development should consider these themes with a view to enhancing the safety and quality of anaesthesia practice in this context.

A priori choice of neuraxial labour analgesia and breastfeeding initiation success: a community-based cohort study in an Italian baby-friendly hospital

Por: Wetzl · R. G. · Delfino · E. · Peano · L. · Gogna · D. · Vidi · Y. · Vielmi · F. · Bianquin · E. · Cerioli · S. · Bettinelli · M. E. · Gianni · M. L. · Frassy · G. · Boris · E. · Arioni · C.
Objective

To investigate whether the nature of the decision about receiving neuraxial labour analgesia is associated with breastfeeding initiation success (BIS), defined as exclusive breastfeeding until discharge associated with postnatal weight loss

Design

Single-centre community-based cohort study.

Setting

An Italian baby-friendly hospital, from 1 July 2011 to 22 September 2015.

Participants

Inclusion criteria: women vaginally delivering singleton cephalic newborns and willing to breastfeed. Exclusion criteria: women who delivered in uterus-dead fetuses, were single or requested but did not receive neuraxial analgesia. Overall, 775 out of the 3628 enrolled women received neuraxial analgesia.

Results

Compared with women who tried to cope with labour pain, those who decided a priori to receive neuraxial analgesia had less BIS (planned vaginal birth: 2121/3421 (62.0%), vs 102/207 (49.3%; p

Conclusions

Compared with trying to cope with labour pain, a priori choice of neuraxial analgesia is negatively associated with BIS. Conversely, compared with having successfully coped with pain, requesting neuraxial analgesia as a last resort is not negatively associated with BIS.

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial

Por: George · S. · Humphreys · S. · Williams · T. · Gelbart · B. · Chavan · A. · Rasmussen · K. · Ganeshalingham · A. · Erickson · S. · Ganu · S. S. · Singhal · N. · Foster · K. · Gannon · B. · Gibbons · K. · Schlapbach · L. J. · Festa · M. · Dalziel · S. · Schibler · A. · on behalf of the Pa
Introduction

Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.

Methods and analysis

The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2

Ethics and dissemination

Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.

Trial registration number

ACTRN12617000147381.

Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual car

Por: Edwards · M. R. · Forbes · G. · MacDonald · N. · Berdunov · V. · Mihaylova · B. · Dias · P. · Thomson · A. · Grocott · M. P. · Mythen · M. G. · Gillies · M. A. · Sander · M. · Phan · T. D. · Evered · L. · Wijeysundera · D. N. · McCluskey · S. A. · Aldecoa · C. · Ripolles-Melchor · J. · H
Introduction

Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice.

Methods

The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide.

Ethics/dissemination

The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal.

Trial registration number

ISRCTN39653756.

Protocol for a prospective observational study to develop a frailty index for use in perioperative and critical care

Por: Darvall · J. N. · Braat · S. · Story · D. A. · Greentree · K. · Bose · T. · Loth · J. · Lim · W. K.
Introduction

Frailty is of increasing importance to perioperative and critical care medicine, as the proportion of older patients increases globally. Evidence continues to emerge of the considerable impact frailty has on adverse outcomes from both surgery and critical care, which has led to a proliferation of different frailty measurement tools in recent years. Despite this, there remains a lack of easily implemented, comprehensive frailty assessment tools specific to these complex populations. Development of a frailty index using routinely collected hospital data, able to leverage the automated aspects of an electronic medical record, would aid risk stratification and benefit clinicians and patients alike.

Methods and analysis

This is a prospective observational study. 150 intensive care unit (ICU) patients aged ≥50 years and 200 surgical patients aged ≥65 years will be enrolled. The primary objective is to develop a frailty index. Secondary objectives include assessing its ability to predict in-hospital mortality and/or discharge to a new non-home location; the performance of the frailty index in predicting postoperative and ICU complications, as well as health-related quality of life at 6 months; to compare the performance of the frailty index against existing frailty measurement and risk stratification tools; and to assess its modification by patients’ health assets.

Ethics and dissemination

This study has been approved by the Melbourne Health Human Research Ethics Committee(20 January 2017, HREC/16/MH/321). Dissemination will be via international and national anaesthetic and critical care conferences, and publication in the peer-reviewed literature.

Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol

Por: Rantasalo · M. T. · Palanne · R. · Juutilainen · K. · Kairaluoma · P. · Linko · R. · Reponen · E. · Helkamaa · T. · Vakkuri · A. · Olkkola · K. T. · Madanat · R. · Skants · N. K. A.
Introduction

Total knee arthroplasty is a highly effective treatment for end-stage knee osteoarthritis, and it is usually performed under spinal or general anaesthesia with or without a surgical tourniquet. Some debate about the preferred mode of anaesthesia regarding patient outcomes remains. The aim of this study, which compares general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty, is to determine the optimal type of anaesthesia regimen and assess the effect of a tourniquet on the patient’s recovery following total knee arthroplasty.

Methods and analysis

This study is a randomised, controlled, parallel-group, four-arm study comparing spinal and general anaesthesia with and without a tourniquet in 400 patients undergoing fast-track total knee arthroplasty, with a 12-month follow-up. The primary outcome is cumulative intravenous oxycodone consumption by patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative nausea and vomiting, the length of hospital stay, the duration of the surgery, blood loss, demand for surgical unit resources, complications, readmissions, postoperative knee function, range of motion, health-related quality of life, prolonged pain and mortality.

Ethics and dissemination

This study’s protocol is in accordance with the declaration of Helsinki. The results of this study will be disseminated in international peer-reviewed journals.

Trial registration number

NCT03364088; Pre-results.

Risk factors for opioid-induced respiratory depression in surgical patients: a systematic review and meta-analyses

Por: Gupta · K. · Nagappa · M. · Prasad · A. · Abrahamyan · L. · Wong · J. · Weingarten · T. N. · Chung · F.
Objective

This systematic review and meta-analysis aim to evaluate the risk factors associated with postoperative opioid-induced respiratory depression (OIRD).

Design

Systematic review and meta-analysis.

Data sources

PubMed-MEDLINE, MEDLINE in-process, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PubMed and Clinicaltrials.gov (January 1946 to November 2017).

Eligibility criteria

The inclusion criteria were: (1) adult patients 18 years or older who were administered opioids after surgery and developed postoperative OIRD (OIRD group); (2) all studies which reported both OIRD events and associated risk factors; (3) all studies with reported data for each risk factor on patients with no OIRD (control group) and (4) published articles in English language.

Data analysis

We used a random effects inverse variance analysis to evaluate the existing evidence of risk factors associated with OIRD. Newcastle-Ottawa scale scoring system was used to assess quality of study.

Results

Twelve observational studies were included from 8690 citations. The incidence of postoperative OIRD was 5.0 cases per 1000 anaesthetics administered (95% CI: 4.8 to 5.1; total patients: 841 424; OIRD: 4194). Eighty-five per cent of OIRD occurred within the first 24 hours postoperatively. Increased risk for OIRD was associated with pre-existing cardiac disease (OIRD vs control: 42.8% vs 29.6%; OR: 1.7; 95% CI: 1.2 to 2.5; I2: 0%; p2: 0%; p2: 31%; p=0.0003). The morphine equivalent daily dose of the postoperative opioids was higher in the OIRD group than in the control; (24.7±14 mg vs 18.9±13.0 mg; mean difference: 2.8; 95% CI: 0.4 to 5.3; I2: 98%; p=0.02). There was no significant association between OIRD and age, gender, body mass index or American Society of Anesthesiologists physical status.

Conclusion

Patients with cardiac, respiratory disease and/or obstructive sleep apnoea were at increased risk for OIRD. Patients with postoperative OIRD received higher doses of morphine equivalent daily dose.

Determining correct tracheal tube insertion depth by measuring distance between endotracheal tube cuff and vocal cords by ultrasound in Chinese adults: a prospective case-control study

Por: Chen · X. · Zhai · W. · Yu · Z. · Geng · J. · Li · M.
Objectives

Unrecognised malposition of the endotracheal tube can lead to severe complications in patients under general anaesthesia. The purpose of this study was to verify the feasibility of using ultrasound to measure the distance between the upper edge of saline-inflated cuff and the vocal cords.

Design

Prospective case-control study.

Setting

A tertiary hospital in Beijing, China.

Methods

In this prospective study, 105 adult patients who required general anaesthesia were enrolled. Prior to induction, ultrasound was used to identify the position of the vocal cords. After intubation, the endotracheal tube (ETT) was fixed at a depth of 23 cm at the upper incisors in men and 21 cm in women. The depth of intubation was verified by video-assisted laryngoscopy. The distance between the upper edge of the saline-inflated cuff and the vocal cords was measured by ultrasound; the ideal distance was considered to be 1.9–4.1 cm.

Results

Among the 105 cases, two cuffs were too close to the vocal cords and one too far away from the vocal cords. These diagnoses were made by ultrasound and were in agreement with results from direct laryngoscopy. The overall accuracy of ultrasound in identifying malposition of the cuff was 100.0% (95% CI: 96.6% to 100%). The sensitivity, specificity, positive predictive value and negative predictive value of ultrasound were, respectively, 100% (95% CI: 96.5% to 100%), 100% (95% CI: 29.2% to 100%), 100% (95% CI: 96.5% to 100%) and 100% (95% CI: 29.2% to 100%).

Conclusion

Identification of the upper edge of the saline-inflated cuff and the vocal cords by ultrasound to assess the location of the ETT is a reliable method. It can be used to avoid malposition of the ETT cuff and reduce the incidence of vocal cords injury after intubation.

Trial registration number

ChiCTR-DDD-17011048.

Effect of regional versus general anaesthesia on postoperative delirium in elderly patients undergoing surgery for hip fracture: a systematic review

Por: Patel · V. · Champaneria · R. · Dretzke · J. · Yeung · J.
Objective

Older patients with hip fractures who are undergoing surgery are at high risk of significant mortality and morbidity including postoperative delirium. It is unclear whether different types of anaesthesia may reduce the incidence of postoperative delirium. This systematic review will investigate the impact of anaesthetic technique on postoperative delirium. Other outcomes included mortality, length of stay, complications and functional outcomes.

Design

Systematic review of randomised controlled trials and non-randomised controlled studies.

Data sources

Bibliographic databases were searched from inception to June 2018. Web of Science and ZETOC databases were searched for conference proceedings. Reference lists of relevant articles were checked, and clinical trial registers were searched to identify ongoing trials.

Eligibility criteria

Studies were eligible if general and regional anaesthesia were compared in patients (aged 60 and over) undergoing hip fracture surgery, reporting primary outcome of postoperative delirium and secondary outcomes of mortality, length of hospital stay, adverse events, functional outcomes, discharge location and quality of life. Exclusion criteria were anaesthetic technique or drug not considered current standard practice; patients undergoing hip fracture surgery alongside other surgery and uncontrolled studies.

Results

One hundred and four studies were included. There was no evidence to suggest that anaesthesia type influences postoperative delirium or mortality. Some studies suggested a small reduction in length of hospital stay with regional anaesthesia. There was some evidence to suggest that respiratory complications and intraoperative hypotension were more common with general anaesthesia. Heterogeneity precluded meta-analysis. All findings were described narratively and data were presented where possible in forest plots for illustrative purposes.

Conclusions

While there was no evidence to suggest that anaesthesia types influence postoperative delirium, the evidence base is lacking. There is a need to ascertain the impact of type of anaesthesia on outcomes with an adequately powered, methodologically rigorous study.

PROSPERO registration number

CRD42015020166.

Perioperative application of dexmedetomidine for postoperative systemic inflammatory response syndrome in patients undergoing percutaneous nephrolithotomy lithotripsy: results of a randomised controlled trial

Por: Deng · Y. · Tan · F. · Gan · X. · Li · X. · Ge · M. · Gong · C. · Hei · Z. · Zhu · Q. · Zhou · S.
Objective

Our previous retrospective study demonstrated that perioperative dexmedetomidine (Dex) administration was associated with low systemic inflammatory response syndrome (SIRS) incidence. The present study was designed to investigate whether perioperative administration of Dex decreases the incidence of postpercutaneous nephrolithotomy lithotripsy (PCNL) SIRS in patients who undergo PCNL.

Design

A randomised controlled trial was designed.

Participants

A total of 190 patients were randomly assigned to receive Dex (DEX group, n=95) or saline control (CON group, n=95) and completed the study. In the DEX group, Dex was loaded (1 µg/kg) before anaesthesia induction and was infused (0.5 µg/kg/h) during surgery.

Outcomes

The incidences of postoperative SIRS were recorded. Serum interleukin-6 (IL-6) and tumour necrosis factor α(TNF-α) were measured.

Results

The incidence rates of SIRS were significantly lower in the DEX group than in the CON group (35.8% vs 50.5%, p=0.04). No patients developed sepsis in either group. These results might be attributed to inhibition of inflammatory responses and the resulting lower serum levels of IL-6 and TNF-α, caused by Dex administration. However, compared with the CON group, the lower incidence rate of SIRS in the DEX group did not result in better outcomes, such as shorter postoperative hospitalisation stays and lower costs.

Conclusion

The present study showed that Dex administration during PCNL might be beneficial for decreasing the incidence of SIRS through inhibiting the release of inflammatory mediators, but not clinical consequences such as postoperative hospitalisation duration and costs. Further effects of Dex administration on SIRS in patients who are scheduled for PCNL should be explored in future studies.

Trial registration number

ChiCTR-ICR-15006167.

Protocol for a randomised, double-blind, placebo-controlled trial to explore the effect of tramadol in the prevention of postpartum depression (ETPPD)

Por: Duan · G. · Wu · Z. · Zhao · P. · Peng · J. · Chen · Z. · Zhang · Q. · Xu · R. · Li · H.
Introduction

Postpartum depression is one of the most commonly experienced psychological disorders for women patients undergoing caesarean section, which accounts for about one-third of puerpera worldwide. Tramadol, a commonly used analgesic with an inhibitory effect on the reuptake of norepinephrine and serotonin, is an effective and well-tolerated agent for analgesia after caesarean section. Based on the role of changes in the postpartum levels of serotonin and norepinephrine in postpartum depression, we speculated that postoperative intravenous analgesia using tramadol may decrease the incidence of postpartum depression for caesarean patients. Therefore, this trial aimed to explore the effect of tramadol in the prevention of postpartum depression.

Methods and analysis

A randomised double-blind placebo-controlled trial will be performed and 1230 singleton parturients will be randomised to receive patient-controlled intravenous analgesia with tramadol or hydromorphone, or patient-controlled epidural analgesia with ropivacaine. The primary outcome of this trial will be the incidence of postpartum depression at 4 weeks after the caesarean section, together with the collection of the relevant data during hospitalisation and at 3 months after the caesarean section. Subgroup data according to the preoperative depression score will be analysed. Demographic characteristics, postoperative analgesic effects and postoperative recovery score will also be summarised and presented.

Ethics and dissemination

The current trial protocol was approved by the Institutional Ethics Committee of Xinqiao Hospital (ID: 2017–026), Third Military Medical University, Chongqing, China. The results of this trial will be disseminated at scientific meetings and in a peer-reviewed journal.

Trial registration number

NCT03309163; Pre-results.

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