Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety

Not Applicable

Completed

• Conditions: Neuromuscular Blocking Agents; Surgery--Complications; Neuromuscular Blockade; Anesthetics; Rocuronium; Anesthesia Complication
• Interventions: Other: Deep neuromuscular block

• Registration Number: NCT04124757
• Lead Sponsor: Leiden University Medical Center

Brief Summary

Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) improves the surgical working conditions over a moderate NMB and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. Small prospective or retrospective studies shown an decrease of the incidence of intraoperative adverse events and postoperative complications after a deep NMB. There is a need to confirm these outcome data prospectively, in a large number of patients and clinics and during a variety of surgical procedures.

Detailed Description

Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) (post tetanic count (PTC) 1-2 twitches) improves the surgical working conditions over a moderate NMB (TOF count 1-3 twitches) and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. A recent retrospective analysis of neuromuscular management during laparoscopic retroperitoneal surgery showed a reduced rate of unplanned 30 day readmissions when a deep NMB over a moderate NMB was applied (3.8% vs. 12.7%).In addition, a pooled analysis of 4 randomized controlled trials comparing different levels of intra-abdominal pressure and neuromuscular blockade during laparoscopic donor nephrectomy, showed a significant reduction in the incidence of intra-operative surgical complications from 12.6% with moderate NMB to 4.8% with deep NMB.

These previous observations were made in small prospective or retrospective studies. There is a need to confirm these outcome data prospectively, in a larger prospective trial for a variety of surgical procedures. We therefore propose a multi-center, randomized controlled trial, to study the effect of a deep NMB (PTC 1-2 twitches) versus standard NMB (single induction dose rocuronium) in a variety of laparoscopic surgical procedures on the incidence of intraoperative adverse events and postoperative outcome data.

In this study the effect of deep neuromuscular block compared to standard neuromuscular block on intra-operative adverse events during laparoscopic surgery using the CLASSIC score system is evaluated.

Study Timeline

• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2020-02-11
• Status Verified: 2024-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 731

Inclusion Criteria

• Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: 'MAJOR', 'MAJOR Plus or 'COMPLEX MAJOR'
• ASA (merican society of anesthesiologists) class I-III
• > 18 years of age
• Ability to give oral and written informed consent

Exclusion Criteria

• Low or intermediate complexity laparoscopic procedures (BUPA 'SIMPLE' or 'INTER')
• Known or suspected neuromuscular disorders impairing neuromuscular function
• Allergies to muscle relaxants, anesthetics or narcotics mentioned in paragraph 5.2
• A (family) history of malignant hyperthermia
• Women who are or may be pregnant or are currently breast feeding
• Chronic use of any type of opioid or psychotropic drug
• Use of NSAID's shorter than 5 days before surgery
• Indication for rapid sequence induction
• Contra-indication for sugammadex use (e.g. known sugammadex allergy or Glomerular Filtration Rate <30 ml/min)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular block	Deep neuromuscular block	Subjects will receive high dose rocuronium induction dose followed by continuous rocuronium administration, to achieve a depth of neuromuscular block of 1-2 twitches post tetanic count

Primary Outcome Measures

Name	Time	Method
Classic score	Day of surgery	The incidence of symptomatic intra-operative adverse events requiring intervention or treatment (ClassIntra®grade ≥ 2) 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. A recent update of the ClassIntra®grade also involved intraoperative adverse events related to anesthesia \[Gawria et al 2023\]. This study will use both the original classic scoring, as well as an adapted version of the updated classic scoring system.; The Classic score; classification of intraoperative complications, is a 6 point scale ranging from no complications (0) to fatal complications (5).

Secondary Outcome Measures

Name	Time	Method
L-SRS (Leiden Surgical Rating Scale)	Day of surgery	To study the effect of deep neuromuscular block compared to standard neuromuscular block on peroperative surgical working conditions following the Leiden Surgical Rating scale (a 5 point scale, ranging from poor (1) to excellent (5) surgical conditions.
Quality of recovery (QoR)	2 postoperative days	To study the effect of deep neuromuscular block compared to standard neuromuscular block on Quality of Recovery at post-operative day 1, 2 according to the Quality of Recovery-40
Quality of life (QoL)	30 postoperative days	To study the effect of deep neuromuscular block compared to standard neuromuscular block on Quality of life at post-operative day 30 Short Form-36
30 day post-operative complications	30 postoperative days	To study the effect of deep neuromuscular block compared to standard neuromuscular block on 30 day post-operative complications according the Clavien-Dindo score en Comprehensive Complication Index and unplanned readmissions

Trial Locations

Locations (8)

Université De Lorraine; 🇫🇷 Nancy, Meurthe-et-Moselle, France

Istituto Nazionale Dei Tumori; 🇮🇹 Milano, Italy

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands

LUMC; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Noordwest ziekenhuis groep; 🇳🇱 Alkmaar, Netherlands

Netherlands Cancer institute; 🇳🇱 Amsterdam, Netherlands

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Hospital Universitari I Politecnic La Fe; 🇪🇸 Valencia, Spain