Dataset Information

GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery.

ABSTRACT:

Background

Patients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.

Methods/design

A two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.

Trial registration

Current Controlled Trials ISRCTN00525237.

SUBMITTER: Gough MJ

PROVIDER: S-EPMC2413207 | biostudies-literature | 2008 May

REPOSITORIES: biostudies-literature

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Publications

GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery.

Gough Michael J MJ Bodenham Andrew A Horrocks Michael M Colam Bridget B Lewis Steff C SC Rothwell Peter M PM Banning Adrian P AP Torgerson David D Gough Moira M Dellagrammaticas Demosthenes D Leigh-Brown Anne A Liapis Christos C Warlow Charles C

Trials 20080521

<h4>Background</h4>Patients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which ...[more]

PMID: 18495004

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Project description:BackgroundPrevious studies have suggested that monitoring the levels of both hypnosis and antinociception could reduce periods of inadequate anaesthesia. However, the evidence regarding associated benefits of this monitoring is still limited.ObjectiveThe primary objective of this study was to confirm that guidance of anaesthesia by depth of hypnosis and antinociception monitoring decreases the number of inadequate anaesthesia events in comparison with standard clinical practice.DesignA multicentre, single-blinded, randomised controlled trial.SettingThe study was conducted in four European University hospitals in four different countries between December 2013 and November 2016.PatientsThe study population consisted of a total of 494 adult patients undergoing elective surgery requiring tracheal intubation.InterventionsThe patients were allocated to one of two groups. The first group was treated using Entropy for depth of hypnosis and surgical pleth index to determine depth of antinociception (adequacy of anaesthesia group; AoA group). The second group was monitored using standard monitoring alone (control group). Anaesthesia was conducted with target-controlled infusions of propofol and remifentanil.Main outcome measuresThe primary outcome of the study was the number of total unwanted events for example signs of inadequately light or unintentionally deep anaesthesia.ResultsEvidence of inadequate anaesthesia had an incidence of around 0.7 events per patient in both groups with no difference between groups (P?=?0.519). In the AoA group, the overall consumption of propofol was significantly reduced (6.9 vs. 7.5?mg?kg?h, P?=?0.008) in comparison with the control group. The consumption of remifentanil was equal in both groups. The times to emergence [8.0 vs. 9.6?min (P?=?0.005)] and full recovery in the postanaesthesia care unit (P?=?0.043) were significantly shorter in the AoA group. No differences were seen in postoperative pain scores or in the use of analgesics.ConclusionIn the current study, the guidance of total intravenous anaesthesia by Entropy and surgical pleth index in comparison with standard monitoring alone was not able to validate reduction of unwanted anaesthesia events. However, there was a reduction in the use of propofol, and shorter times for emergence and time spent in the postanaesthesia care unit.Trial registrationat ClinicalTrials.gov NCT01928875.

Project description:BackgroundPreclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial.MethodsIn this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks' gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevoflurane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov, number NCT00756600.FindingsBetween Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the as-per-protocol analysis, the cognitive composite score (mean [SD]) was 98.6 (14.2) in the awake-regional group and 98.2 (14.7) in the general anaesthesia group. There was equivalence in mean between groups (awake-regional minus general anaesthesia 0.169, 95% CI -2.30 to 2.64). The median duration of anaesthesia in the general anaesthesia group was 54 min.InterpretationFor this secondary outcome, we found no evidence that just less than 1 h of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at 2 years of age compared with awake-regional anaesthesia.FundingAustralia National Health and Medical Research Council (NHMRC), Health Technologies Assessment-National Institute for Health Research UK, National Institutes of Health, Food and Drug Administration, Australian and New Zealand College of Anaesthetists, Murdoch Childrens Research Institute, Canadian Institute of Health Research, Canadian Anesthesiologists' Society, Pfizer Canada, Italian Ministry of Heath, Fonds NutsOhra, and UK Clinical Research Network (UKCRN).

Project description:BackgroundIn laboratory animals, exposure to most general anaesthetics leads to neurotoxicity manifested by neuronal cell death and abnormal behaviour and cognition. Some large human cohort studies have shown an association between general anaesthesia at a young age and subsequent neurodevelopmental deficits, but these studies are prone to bias. Others have found no evidence for an association. We aimed to establish whether general anaesthesia in early infancy affects neurodevelopmental outcomes.MethodsIn this international, assessor-masked, equivalence, randomised, controlled trial conducted at 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand, we recruited infants of less than 60 weeks' postmenstrual age who were born at more than 26 weeks' gestation and were undergoing inguinal herniorrhaphy, without previous exposure to general anaesthesia or risk factors for neurological injury. Patients were randomly assigned (1:1) by use of a web-based randomisation service to receive either awake-regional anaesthetic or sevoflurane-based general anaesthetic. Anaesthetists were aware of group allocation, but individuals administering the neurodevelopmental assessments were not. Parents were informed of their infants group allocation upon request, but were told to mask this information from assessors. The primary outcome measure was full-scale intelligence quotient (FSIQ) on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III), at 5 years of age. The primary analysis was done on a per-protocol basis, adjusted for gestational age at birth and country, with multiple imputation used to account for missing data. An intention-to-treat analysis was also done. A difference in means of 5 points was predefined as the clinical equivalence margin. This completed trial is registered with ANZCTR, number ACTRN12606000441516, and ClinicalTrials.gov, number NCT00756600.FindingsBetween Feb 9, 2007, and Jan 31, 2013, 4023 infants were screened and 722 were randomly allocated: 363 (50%) to the awake-regional anaesthesia group and 359 (50%) to the general anaesthesia group. There were 74 protocol violations in the awake-regional anaesthesia group and two in the general anaesthesia group. Primary outcome data for the per-protocol analysis were obtained from 205 children in the awake-regional anaesthesia group and 242 in the general anaesthesia group. The median duration of general anaesthesia was 54 min (IQR 41-70). The mean FSIQ score was 99·08 (SD 18·35) in the awake-regional anaesthesia group and 98·97 (19·66) in the general anaesthesia group, with a difference in means (awake-regional anaesthesia minus general anaesthesia) of 0·23 (95% CI -2·59 to 3·06), providing strong evidence of equivalence. The results of the intention-to-treat analysis were similar to those of the per-protocol analysis.InterpretationSlightly less than 1 h of general anaesthesia in early infancy does not alter neurodevelopmental outcome at age 5 years compared with awake-regional anaesthesia in a predominantly male study population.FundingUS National Institutes of Health, US Food and Drug Administration, Thrasher Research Fund, Australian National Health and Medical Research Council, Health Technologies Assessment-National Institute for Health Research (UK), Australian and New Zealand College of Anaesthetists, Murdoch Children's Research Institute, Canadian Institutes of Health Research, Canadian Anesthesiologists Society, Pfizer Canada, Italian Ministry of Health, Fonds NutsOhra, UK Clinical Research Network, Perth Children's Hospital Foundation, the Stan Perron Charitable Trust, and the Callahan Estate.

Project description:ObjectivesTo determine whether administration of local anaesthetic at the site of skin incision during open lacrimal drainage surgery under general anaesthesia alters the total dosage of anaesthetic drugs required during total intravenous anaesthesia (TIVA), and whether it alters postoperative pain and recovery.Study designMasked comparison of a randomized, two-group interventional study.Patients and methodsPatients undergoing unilateral external dacryocystorhinostomy under total intravenous general anaesthesia were recruited from the lacrimal service at Moorfields Eye Hospital between September 2012 and February 2014. The patients were randomised to receive, after induction and stabilisation of general anaesthesia, infiltration of the ipsilateral paranasal tissues with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine ("treatment" group), or a sham injection ("control" group); the infiltration was performed about 7 min prior to the skin incision. The infusion rates for propofol and remifentanil were adjusted to maintain a steady intra-operative mean blood pressure of 55-70 mmHg and BIS score of 40-60%. The time taken for extubation of the patient after cessation of TIVA was recorded, and postoperative pain scores (on a Likert scale from 0-10) were taken at regular intervals after extubation. The average intra-operative mean blood pressures, total drug usage, extubation time and pain scores for each of the two groups were compared using two-tail Student's t-testing and Wilcoxon rank sum testing.ResultsThere were 12 patients (7 female; 58%) in the treatment group and 11 (7 female; 64%) in the control group, with similar average age at surgery (59 years treatment, 53 years control; p = 0.38) The average operative time was 45 min in the treatment group (median 42, range 30-55) and 47 min (median 45; range 37-61) in the control group (p = 0.52). The mean dosage of propofol required to maintain satisfactory GA was significantly less in the "treatment" group (89.8 mcg/kg/min) as compared to the "control" group (mean 126 mcg/kg/min) (p = 0.0007). Likewise, remifentanil dosage was significantly less in the "treatment" group (100 ng/kg/min) as compared to controls (259 ng/kg/min) (p = 0.00007). The mean non-invasive blood pressure was consistently lower during surgery in the "treated" group, and showed less intra-operative variation. After surgery, the patients receiving LA had a significantly shorter extubation time (mean time 6.0 min in "treated" group, 12.1 min in "controls"; P < 0.0002) and also significantly lower pain scores at 10, 30, 60, 120 and 180 min after extubation (p < 0.01, p < 0.01, p < 0.01, p < 0.01 and p < 0.05, respectively).ConclusionsIpsilateral infiltration of local anaesthesia containing epinephrine in the paranasal tissues just prior to open dacryocystorhinostomy under total intravenous anaesthesia is associated with a 28% reduction in mean propofol usage, and a 61% reduction in remifentanil usage. LA usage during GA also produces improved and less variable intra-operative mean blood pressures, a significantly shorter extubation time and significantly lower postoperative pain scores.

Project description:ObjectivesWe conducted a systematic review and meta-analysis to identify the potential favourable effects of local anaesthesia plus sedation (LAS) compared with general anaesthesia (GA) in transcatheter aortic valve implantation (TAVI).MethodsElectronic databases (PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials) and the reference lists of eligible publications were screened for randomised controlled trials (RCTs) and observational studies published between 1 January 2006 and 26 June 2016 that compare LAS to GA in an adult study population undergoing TAVI. We conducted study quality assessments using the Cochrane risk of bias tool and structured the review according to PRISMA. A meta-analysis calculating the pooled risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) under the assumption of a random-effects model was performed. Statistical heterogeneity was evaluated using the I² statistic and Cochran's Q-test.ResultsAfter database screening, one RCT and 19 observational studies were included in the review. We found no differences between LAS and GA in terms of 30-day mortality, in-hospital mortality and other endpoints that addressed safety and complication rates. LAS was associated with a shorter ICU and hospital stay and with lower rates of catecholamine administration and red blood cell transfusion. New pacemaker implantations occurred more frequently under LAS. The overall conversion rate from LAS to GA was 6.2%.ConclusionFor TAVI, both LAS and GA are feasible and safe. LAS may have some benefits such as increased haemodynamic stability and shorter hospital and ICU stays, but it does not impact 30-day mortality. Since there is a paucity of randomised trial data and the findings are mainly based on observational study data, this review should be considered as a hypothesis-generating article for subsequent RCTs that are required to confirm the potential favourable effects we detected for LAS.Registration numberCRD42016048398 (PROSPERO).

Project description:BackgroundThe role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery.MethodsIn this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer-generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574.FindingsFrom February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12-12) in the higher PEEP group and 2 cm H2O (0-2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86-1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs.InterpretationA strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres.FundingAcademic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology.

Project description:IntroductionThe use of Bispectral Index (BIS) monitors for assessing depth of sedation has led to a reduction in both the incidence of awareness and anaesthetic consumption in total intravenous anaesthesia. However, these monitors are vulnerable to artefacts. In addition to the processed number, the raw frontal electroencephalogram (EEG) can be displayed as a curve on the same monitor. Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns. We hypothesise that quality of recovery (QoR) in patients undergoing laparoscopic surgery is better, if propofol is titrated by anaesthesia practitioners able to interpret the EEG.Methods and analysisThis is a multicentre, double-blind (patients and outcome assessors) randomised controlled trial taking place in four Swiss hospitals. Patients aged 18 years or older undergoing laparoscopic procedures with general anaesthesia using propofol and anaesthesia practitioners with more than 2 years experience will be eligible. The primary study outcome is the difference in QoR 24 hours after surgery. Secondary outcomes are propofol consumption, incidence of postoperative nausea and vomiting (PONV) and postoperative delirium.QoR and propofol consumption are compared between both groups using a two-sample t-test. Fisher's exact test is used to compare the incidences of PONV and delirium. A total of 200 anaesthesia practitioners (and 200 patients) are required to have an 80% chance of detecting the minimum relevant difference for the QoR-15 as significant at the 5% level assuming a SD of 20.Ethics and disseminationEthical approval has been obtained from all responsible ethics committees (lead committee: Ethikkommission Nordwest- und Zentralschweiz, 16 January 2021). The findings of the trial will be published in a peer-reviewed journal, presented at international conferences, and may lead to a change in titrating propofol in clinical practice.Trial registration numberwww.Clinicaltrialsgov:NCT04105660.

Project description:ObjectiveTo investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use.DesignBlinded randomised controlled study.SettingFive tertiary care hospitals in Germany.Participants385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group.InterventionThe intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape.Main outcome measuresThe main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain).ResultsCompared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen's d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported.ConclusionsTherapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery.Trial registrationGerman Clinical Trial Register DRKS00013800.

Project description:IntroductionPostoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery.Methods and analysisRAGA-delirium is a pragmatic, multicentre, prospective, parallel grouped, randomised controlled clinical trial comparing RA or GA for hip fracture surgery. A total of 1000 patients who are 65 years or over and who are having planned hip fracture surgery in nine clinical trial centres of China will be randomised in a 1:1 ratio to receive either anaesthesia for the surgery. The primary endpoint will be the incidence of POD at day 7. The secondary endpoints will be the subtype, severity and duration of delirium, postoperative acute pain score, incidence of other postoperative non-delirium complications, quality of life and cost-effective outcomes. Randomisation will be performed at the patient level using computer-generated assignment. Outcome assessors will be blinded from intervention assignment. Assessments will be conducted before surgery, intraoperatively, postoperatively, during the hospital stay, at 30-day, 6-month and 1-year postoperative intervals.Potential impact of studyThis study will provide clinical evidence with a more robust methodology to help anaesthetists in selecting appropriate anaesthesia for older patients with high risk for POD. At the era of increasing emphasis on delirium prevention, this trial has the potential to inform the future national guideline to reduce POD.Ethics and disseminationEthical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT02213380); pre-results.

Dataset Information

GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery.

Background

Methods/design

Trial registration

Publications

GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery.

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