Trial Outcomes & Findings for Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety (NCT NCT04124757)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

731 participants

Primary outcome timeframe

Day of surgery

Results posted on

2025-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Neuromuscular Blockade Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Overall Study STARTED	367	364
Overall Study COMPLETED	365	363
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Neuromuscular Blockade n=362 Participants Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	Deep Neuromuscular Block n=361 Participants 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count	Total n=723 Participants Total of all reporting groups
Age, Continuous	58.4 year STANDARD_DEVIATION 13.7 • n=5 Participants	58.0 year STANDARD_DEVIATION 13.5 • n=7 Participants	58.2 year STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	139 Participants n=7 Participants	289 Participants n=5 Participants
Sex: Female, Male Male	212 Participants n=5 Participants	222 Participants n=7 Participants	434 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	362 Participants n=5 Participants	361 Participants n=7 Participants	723 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery

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).

Outcome measures

Outcome measures
Measure	Standard Neuromuscular Blockade n=361 Participants Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	Deep Neuromuscular Block n=362 Participants 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Classic Score>1	66 participants	54 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Neuromuscular Blockade n=361 Participants Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	Deep Neuromuscular Block n=362 Participants 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
L-SRS (Leiden Surgical Rating Scale)	4.6 units on a scale Standard Deviation 0.5	4.9 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Standard Neuromuscular Blockade n=361 Participants Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	Deep Neuromuscular Block n=362 Participants 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
30 Day Post-operative Complications	142 Participants	139 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Standard Neuromuscular Blockade

Serious events: 24 serious events

Other events: 65 other events

Deaths: 0 deaths

Deep Neuromuscular Block

Serious events: 23 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Neuromuscular Blockade n=361 participants at risk Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	Deep Neuromuscular Block n=362 participants at risk 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Surgical and medical procedures Unplanned readmission	6.6% 24/361 • 1 month	6.4% 23/362 • 1 month

Other adverse events

Other adverse events
Measure	Standard Neuromuscular Blockade n=361 participants at risk Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions	Deep Neuromuscular Block n=362 participants at risk 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Gastrointestinal disorders postoperative nausea vomiting	18.0% 65/361 • 1 month	14.1% 51/362 • 1 month

Additional Information

Martijn Boon MD PhD

LUMC

Phone: 003171522301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place