Abstract
BackgroundMuscle relaxants are routinely used during anesthesia to facilitate endotracheal intubation and to optimize surgical conditions. However, controversy remains about the required depth of neuromuscular block (NMB) needed for optimal surgical working conditions and how this relates to other outcomes. For instance, a deep neuromuscular block yields superior surgical working conditions compared to a standard NMB in laparoscopic surgery, however, a robust association to other (safety) outcomes has not yet been established.MethodsTrial design: an international multicenter randomized controlled double-blind strategy trial.Trial population: 922 patients planned for elective, laparoscopic or robotic, abdominal surgery.Intervention: Patients will be randomized to a deep NMB (post-tetanic count 1–2 twitches) or standard care (single-dose muscle relaxant administration at induction and repeated only if warranted by surgical team).Main trial endpoints: Primary endpoint is the difference in incidence of intraoperative adverse events during laparoscopic surgery graded according to ClassIntra® classification (i.e., ClassIntra® grade ≥ 2) between both groups. Secondary endpoints include the surgical working conditions, 30-day postoperative complications, and patients’ quality of recovery.DiscussionThis trial was designed to analyze the effect of deep neuromuscular block compared to standard neuromuscular block on intra- and postoperative adverse events in patients undergoing laparoscopic surgery.Trial registrationClinicalTrials.gov NCT04124757(EURO-RELAX); registration URL: https://clinicaltrials.gov/ct2/show/NCT04124757, registered on October 11th, 2019.
Highlights
Background and rationale {6a} Muscle relaxants are routinely given during general anesthesia to facilitate endotracheal intubation and to improve surgical exposure
The EURO-RELAX trial is an international multicenter randomized controlled double-blind strategy trial that studies the effect of a deep neuromuscular block (NMB) (PTC 1–2 twitches), in comparison to standard NMB, on the incidence of intraoperative adverse events and postoperative outcomes in a variety of laparoscopic surgical procedures
We evaluated the effect size of deep NMB on perioperative complication rate in pooled data of four prospective studies that evaluated the effect of deep NMB on surgical conditions [22,23,24,25]
Summary
Study setting {9} The trial will be performed in academic and nonacademic public hospitals in France, Italy, the Netherlands, and Spain; a list of participating centers is enclosed in the Appendix. Outcomes {12} Main trial parameter/endpoint The incidence of symptomatic intraoperative adverse events requiring intervention or treatment (ClassIntra®grade ≥ 2 [11], Table 1) during laparoscopic surgery in the standard of care versus the deep NMB group, as scored by the attending surgeon and anesthesiologist at the end of every procedure. ▪ Depth of NMB (TOF count/ratio and/or PTC) At the end of the case the following variables will be collected: ▪ ClassIntra® grade [11] ▪ Duration of surgery and anesthesia (minutes) ▪ When applicable, reason of conversion to open procedure ▪ Time of extubation ▪ Cumulative drug dosages (propofol, opioids, muscle relaxant, reversal agent, inotropes, NSAIDs, or metamizole) ▪ Core temperature in degrees Celsius ▪ Surgical satisfaction with the anesthesia: “very dissatisfied”, “dissatisfied”, “satisfied”, to “very satisfied”. Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Not applicable
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