N/A
Completed N=731
Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety
Neuromuscular Blockade · Rocuronium · Anesthetics · Anesthesia Complication
Source: ClinicalTrials.gov NCT04124757 ↗
Enrolled (actual)
731
Serious AEs
6.5%
Results posted
Jun 2025
Primary outcomePrimary: Classic Score>1 — 66; 54 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Classic Score>1 |
66; 54 | — |
| SECONDARY L-SRS (Leiden Surgical Rating Scale) |
4.6; 4.9 | — |
| SECONDARY 30 Day Post-operative Complications |
142; 139 | — |
| SECONDARY Quality of Recovery (QoR) |
— | — |
| SECONDARY Quality of Life (QoL) |
— | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04124757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.