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

NCT04124757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 731

Last updated 2025-06-11

Study results available
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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.

Conditions

  • Neuromuscular Blockade
  • Rocuronium
  • Anesthetics
  • Anesthesia Complication
  • Neuromuscular Blocking Agents
  • Surgery--Complications

Interventions

OTHER

Deep neuromuscular block

Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count

Sponsors & Collaborators

Principal Investigators

  • Monique van Velzen, PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04124757 on ClinicalTrials.gov