Trial Outcomes & Findings for Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions. (NCT NCT03170661)

Last Updated: 2021-05-13

Results Overview

During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

98 participants

Primary outcome timeframe

during surgery

Results posted on

2021-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate Neuromuscular Block Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block Subjects will receive deep neuromuscular block, aimed at 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	49	49
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate Neuromuscular Block n=49 Participants Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.	Deep Neuromuscular Block n=49 Participants In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.	Total n=98 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	51 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment Netherlands	49 participants n=5 Participants	49 participants n=7 Participants	98 participants n=5 Participants
Procedure	49 Laparoscopic renal surgery n=5 Participants	49 Laparoscopic renal surgery n=7 Participants	98 Laparoscopic renal surgery n=5 Participants
Height (m)	1.75 m STANDARD_DEVIATION 0.1 • n=5 Participants	1.75 m STANDARD_DEVIATION 0.1 • n=7 Participants	1.75 m STANDARD_DEVIATION 0.1 • n=5 Participants
Weight (kg)	80 kg STANDARD_DEVIATION 13.5 • n=5 Participants	81.4 kg STANDARD_DEVIATION 13.9 • n=7 Participants	80.7 kg STANDARD_DEVIATION 13.7 • n=5 Participants
American Society of Anesthesiologists physical status classification system 1	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
American Society of Anesthesiologists physical status classification system 2	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
American Society of Anesthesiologists physical status classification system 3	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: during surgery

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=49 Participants Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block n=49 Participants Subjects will receive deep neuromuscular block, aimed at 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
Leiden Surgical Rating Scale	4.8 score on a scale Standard Deviation 0.4	4.8 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals

Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -mean pain scores (numeric rating scale; 0 no pain - 10 worst pain imaginable)

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=49 Participants Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block n=49 Participants Subjects will receive deep neuromuscular block, aimed at 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
Postoperative Measurements and Outcomes; Pain Scores	2.9 units on a scale Standard Deviation 1.9	3.2 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Perioperative measurements at 15 minute interval (on average during 3 hours)

Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=49 Participants Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block n=49 Participants Subjects will receive deep neuromuscular block, aimed at 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
Intraoperative Hemodynamic Conditions	84 millimeters mercury Interval 67.0 to 103.0	85 millimeters mercury Interval 69.0 to 105.0

SECONDARY outcome

Timeframe: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals

Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -ramsay sedation levels (0 = normal alertness, eyes open, responds normal to command 1 = drowsy with open eyes, closed and opened on command 2 = drowsy with closed eyes, opened in response to light auditory stimulus 3 = eyes closed, opened in response to rubbing the shoulder or a loud auditory stimulus 4 = eyes closed and opened only briefly in response to touching the subject 5 = eyes closed, unarousable by touch, aroused by painful 6 = unarousable by pain)

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=49 Participants Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block n=49 Participants Subjects will receive deep neuromuscular block, aimed at 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
Postoperative Measurements and Outcomes; Sedation Levels	0.9 units on a scale Standard Deviation 0.6	1.0 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals

Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -blood oxygen saturation in percent levels between 95-100 are considered normal

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=49 Participants Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block n=49 Participants Subjects will receive deep neuromuscular block, aimed at 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
Postoperative Measurements and Outcomes; Saturation	98 percentage of blood oxygen saturation Standard Deviation 1	98 percentage of blood oxygen saturation Standard Deviation 1

SECONDARY outcome

Timeframe: Perioperative measurements at 15 minute interval (on average during 3 hours)

The median and full range of the average nociception level index will be reported. The nociception level index consist of Ta multiparameter nonlinear combination of heart rate, heart rate variability, amplitude of the finger photoplethysmogram, skin conductance level, fluctuations in skin conductance, and their time derivatives, derived from random forest regression. Random forest is an algorithmic modeling approach that enables combining multiple parameters of different origin and discovering their complex nonlinear interactions. Normal range is between 10-20; 0 indicates no nociceptive events (in example, pain stimuli), 100 indicates severe painful stimuli.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Block n=49 Participants Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four	Deep Neuromuscular Block n=49 Participants Subjects will receive deep neuromuscular block, aimed at 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
Intraoperative Nociception Level	11 score on a scale Interval 1.0 to 42.0	13 score on a scale Interval 4.0 to 27.0

Adverse Events

Moderate NMB

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Deep NMB

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Moderate NMB n=49 participants at risk Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.	Deep NMB n=49 participants at risk In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.
Surgical and medical procedures prolonged hospital stay	6.1% 3/49 • Number of events 3 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website	4.1% 2/49 • Number of events 2 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website
Surgical and medical procedures hospital readmission	4.1% 2/49 • Number of events 2 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website	0.00% 0/49 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website

Other adverse events

Other adverse events
Measure	Moderate NMB n=49 participants at risk Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.	Deep NMB n=49 participants at risk In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.
Surgical and medical procedures Postoperative CT-scan	4.1% 2/49 • Number of events 2 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website	2.0% 1/49 • Number of events 1 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website
Surgical and medical procedures Corneal Erosion	0.00% 0/49 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website	2.0% 1/49 • Number of events 1 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website
Surgical and medical procedures Reflex syncope	2.0% 1/49 • Number of events 1 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website	0.00% 0/49 • Seven days post-procedure follow-up period The definition of adverse events is comparable to the definition by this website

Additional Information

Drs. Maarten Honing

LUMC

Phone: 0715264038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place