Trial Outcomes & Findings for Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients (NCT NCT02553629)

Results Overview

During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

109 participants

Primary outcome timeframe

intraoperative

Results posted on

2017-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate Neuromuscular Block rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Overall Study STARTED	53	56
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Moderate Neuromuscular Block rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Overall Study Logistic reasons	3	6

Baseline Characteristics

Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium	Total n=100 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	47.2 years STANDARD_DEVIATION 11.1 • n=7 Participants	47.1 years STANDARD_DEVIATION 10.9 • n=5 Participants
Gender Female	41 Participants n=5 Participants	39 Participants n=7 Participants	80 Participants n=5 Participants
Gender Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: intraoperative

During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Surgical Rating	4.2 units on a scale Standard Deviation 0.7	4.8 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: intraoperative

The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Extubation	3 minutes Interval 1.0 to 6.0	3 minutes Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: postoperative, for up to 2 hours

pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Pain	4.4 units on a scale Standard Deviation 1.4	3.9 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 2 hours postoperative

Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Respiration	12.7 breaths per minute Standard Deviation 0.7	12.6 breaths per minute Standard Deviation 1.1

SECONDARY outcome

Timeframe: 2 hours postoperative

Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium	Deep Neuromuscular Block n=50 Participants rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium
Mean Arterial Blood Pressure	98 millimeters of mercury Standard Deviation 13	101 millimeters of mercury Standard Deviation 15

Adverse Events

Moderate Neuromuscular Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deep Neuromuscular Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. A. Dahan

Leiden University Medical Center

Phone: +31 71 526 2301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place