Dataset Information

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

ABSTRACT:

Background

Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery.

Methods

The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 hours) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record.

Discussion

We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution.

Trial registration number

NCT04625283, Pre-results Protocol Version 1.0, 2021.

SUBMITTER: Raymond BL

PROVIDER: S-EPMC10055550 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

Raymond Britany L BL Allen Brian F S BFS Freundlich Robert E RE Parrish Crystal G CG Jayaram Jennifer E JE Wanderer Jonathan P JP Rice Todd W TW Lindsell Christopher J CJ Scharfman Kevin H KH Dear Mary L ML Gao Yue Y Hiser William D WD McEvoy Matthew D MD

Research square 20230324

<h4>Background</h4>Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically m ...[more]

PMID: 36993617

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Project description:OBJECTIVE:To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. DESIGN:Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. SETTING:Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. PARTICIPANTS:441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. INTERVENTIONS:Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. MAIN OUTCOME MEASURES:The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. RESULTS:The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected. CONCLUSION:In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

Project description:ObjectiveThe aim of this systematic review and meta-analysis is to evaluate whether the implementation of Enhanced Recovery After Surgery (ERAS) protocols for adult patients undergoing emergency intra-abdominal surgery decreases postoperative length of stay, postoperative morbidity, and mortality compared to conventional perioperative care.MethodsA systematic review and meta-analysis will be performed and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). It has been registered on the International Prospective Register for Systematic Reviews (PROSPERO; CRD42023391709). A comprehensive, electronic search strategy will be used to identify studies published and indexed in MEDLINE, EMBASE, Web of Science, CENTRAL, and Pubmed databases since their inception. Trial registries and references of included studies and pertinent previous systematic reviews will also be searched. Studies will be included if they are randomized controlled trials or cohort studies evaluating adult patients undergoing emergency intra-abdominal surgery and comparing ERAS or modified ERAS protocols to conventional perioperative care and report one of the following outcomes: postoperative length of stay, overall 30-day morbidity, 30-day mortality, 30-day infectious morbidity, prolonged postoperative ileus, return of bowel function, and 30-day readmissions. A meta-analysis will be performed using a random effects model for all comparative data using Cochrane Review Manager 5.3 (London, United Kingdom).DiscussionERAS protocols have become standard of care for patients undergoing elective surgery. Their use in the setting of emergency surgery is far less common. The aim of this systematic review and meta-analysis is to assess whether there are benefits in patient important outcomes with the implementation of ERAS protocols for patients undergoing emergency intra-abdominal surgery. Ultimately, we hope to promote their use and further large randomized controlled trials evaluating emergency surgery ERAS programs.Prospero registration numberCRD42023391709.

Project description:BackgroundBariatric surgery depends on the development of novel anesthetic techniques to reduce the incidence of complications and improve postoperative outcomes. Ketamine and dexmedetomidine have been used for perioperative analgesia and we hypothesized that they would decrease postoperative morphine requirements. The objective of this trial is to study whether choice of ketamine or dexmedetomidine infusion would affect postoperative total morphine consumption.MethodsNinety patients were equally randomized into three groups. The ketamine group received a bolus dose (0.3 mg/kg) of ketamine over 10 min, followed by an infusion of the same drug (0.3 mg/kg/h). The dexmedetomidine group received a bolus dose (0.5 mcg/kg) of dexmedetomidine over 10 min, followed by an infusion of this drug (0.5 mg/kg/h). The control group received a saline infusion. All infusions were given till 10 min before the end of surgeries. Intraoperative fentanyl was given when patient developed hypertension and tachycardia despite adequate anesthesia and muscle relaxation. Postoperative pain was managed by a rescue dose of 4 mg of IV morphine, with a minimum interval of 6 h between morphine doses if the numerical rating scale (NRS) score was ≥ 4. The primary outcome was the total morphine dose, and the secondary outcomes were intraoperative fentanyl requirement, time to extubation, postoperative nausea and vomiting (PONV), NRS scores, and modified observer's agitation/sedation scale (MOASS) scores.ResultsCompared with ketamine, dexmedetomidine decreased the need for fentanyl intraoperatively (160 ± 42 µg), shortened the time to extubation (3 ± 1 min), and improved MOASS and PONV scores. In turn, ketamine decreased postoperative NRS scores and the need for morphine (3 ± 3 mg).ConclusionsDexmedetomidine treatment was associated with lower fentanyl doses, a shorter time to extubation, and better MOASS and PONV scores. Ketamine treatment was associated with significantly lower NRS scores and morphine doses. These results indicated that dexmedetomidine effectively decreased intraoperative fentanyl requirement and the time to extubation, while ketamine decreased the need for morphine.Trial registrationThis trail was registered on the clinicaltrials.gov registry (NCT04576975) on October 6, 2020.

Dataset Information

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

Background

Methods

Discussion

Trial registration number

Publications

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

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