Trial Outcomes & Findings for Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade (NCT NCT01933425)

Results Overview

Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

1 hour

Results posted on

2015-03-30

Participant Flow

Carried out between November 2013 and April 2014. Center for Minimal Invasive Gynaecology, Aleris-Hamlet Hospital Copenhagen, Denmark. A total of 25 patients were eligible in the study period, of which nine declined to participate, and two were excluded due to the fact that they did not speak Danish. All 14 patients completed the study

Participant milestones

Participant milestones
Measure	Deep Neuromuscular Block First Then no Neuromuscular Block Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade rocuronium sugammadex placebo	No Neuromuscular Block First Then Deep Neuromuscular Block No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade. rocuronium sugammadex placebo
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Characteristics in 14 Women n=14 Participants
Age, Continuous	44.2 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
BMI	22.2 kg/m2 STANDARD_DEVIATION 2.6 • n=5 Participants
Number of patients with previous abdominal surgery	7 participants n=5 Participants
Number of patients with 0 pregnancies	6 participants n=5 Participants
Number of patients with 1 pregnancy	3 participants n=5 Participants
Number of patients with 2 pregnancies	2 participants n=5 Participants
Number of patients with 3 pregnancies	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Comparisons of changes in distances were performed with paired t-test.

Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block n=14 Participants Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).	No Neuromuscular Block n=14 Participants Intraabdominal distance during no neuromuscular block
Intraabdominal Distance (Centimeters)	9.3 centimeters Interval 8.6 to 9.6	9.0 centimeters Interval 8.2 to 9.5

SECONDARY outcome

Timeframe: 1 hour

Population: Comparisons of changes in distances were performed with paired t-test

Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block n=14 Participants Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).	No Neuromuscular Block n=14 Participants Intraabdominal distance during no neuromuscular block
Intraabdominal Distance (Centimeters)	8.6 centimeters Interval 7.7 to 8.9	8.2 centimeters Interval 7.4 to 8.8

SECONDARY outcome

Timeframe: 1 hour

Population: Evaluation of surgical conditions was compared using Mann-Whitney U-test.

Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block n=7 Participants Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).	No Neuromuscular Block n=7 Participants Intraabdominal distance during no neuromuscular block
Surgical Conditions During Suturing of the Abdominal Fascia Optimal (score 1)	7 participants	2 participants
Surgical Conditions During Suturing of the Abdominal Fascia Good (score 2)	0 participants	5 participants
Surgical Conditions During Suturing of the Abdominal Fascia Acceptable (score 3)	0 participants	0 participants
Surgical Conditions During Suturing of the Abdominal Fascia Poor (score 4)	0 participants	0 participants

Adverse Events

Deep Neuromuscular Block First Then no Neuromuscular Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Neuromuscular Block First Then 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

Dr. Matias Vested Madsen

Herlev Hospital, University of Copenhagen, Department of Anesthesiology

Phone: +4538689058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place