An interventional study of Deep neuromuscular block in Neuromuscular Blockade, Rocuronium and Anesthetics, sponsored by Leiden University Medical Center. Completed at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions
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
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
Also known as: High dose rocuronium
Classic Score>1
The incidence of symptomatic intra-operative adverse events requiring intervention or treatment (ClassIntra®grade \>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. 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).
Time frame: Day of surgery
L-SRS (Leiden Surgical Rating Scale)
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.
Time frame: Day of surgery
30 Day Post-operative Complications
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
Time frame: 30 postoperative days
Quality of Recovery (QoR)
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
Time frame: 2 postoperative days
Quality of Life (QoL)
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
Time frame: 30 postoperative days
| Milestone | Standard Neuromuscular Blockade | Deep Neuromuscular Block |
|---|---|---|
| Started | 367 | 364 |
| Completed | 365 | 363 |
| Not completed | 2 | 1 |
The incidence of symptomatic intra-operative adverse events requiring intervention or treatment (ClassIntra®grade \>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. 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).
| participants | Standard Neuromuscular Blockade | Deep Neuromuscular Block |
|---|---|---|
| Classic Score>1 | 66 | 54 |
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.
| units on a scale | Standard Neuromuscular Blockade | Deep Neuromuscular Block |
|---|---|---|
| L-SRS (Leiden Surgical Rating Scale) | 4.6 ± 0.5 | 4.9 ± 0.3 |
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
| Participants | Standard Neuromuscular Blockade | Deep Neuromuscular Block |
|---|---|---|
| 30 Day Post-operative Complications | 142 | 139 |
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Neuromuscular Blockade | 0/361 (0%) | 24/361 (6.6%) | 65/361 (18%) |
| Deep Neuromuscular Block | 0/362 (0%) | 23/362 (6.4%) | 51/362 (14.1%) |
| Event | Standard Neuromuscular Blockade | Deep Neuromuscular Block |
|---|---|---|
| Unplanned readmissionSurgical and medical procedures | 24/361 | 23/362 |
| Event | Standard Neuromuscular Blockade | Deep Neuromuscular Block |
|---|---|---|
| postoperative nausea vomitingGastrointestinal disorders | 65/361 | 51/362 |
| Age, Continuous(year) | Standard Neuromuscular Blockade | Deep Neuromuscular Block | Total |
|---|---|---|---|
| Mean | 58.4 ± 13.7 | 58.0 ± 13.5 | 58.2 ± 13.6 |
| Sex: Female, Male(Participants) | Standard Neuromuscular Blockade | Deep Neuromuscular Block | Total |
|---|---|---|---|
| Female | 150 | 139 | 289 |
| Male | 212 | 222 | 434 |
| Ethnicity (NIH/OMB)(Participants) | Standard Neuromuscular Blockade | Deep Neuromuscular Block | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 362 | 361 | 723 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.
Supporting information: Study protocol, Sap
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Leiden University Medical Center