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Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

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ClinicalTrials.gov Identifier: NCT01933425
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Matias Vested Madsen, Herlev Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuromuscular Blockade
Interventions Drug: rocuronium
Drug: sugammadex
Drug: placebo
Enrollment 14
Recruitment Details

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

Pre-assignment Details  
Arm/Group Title Deep Neuromuscular Block First Then no Neuromuscular Block No Neuromuscular Block First Then Deep Neuromuscular Block
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Patient Characteristics in 14 Women
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Females
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
44.2  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 14 participants
22.2  (2.6)
Number of patients with previous abdominal surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
7
Number of patients with 0 pregnancies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
6
Number of patients with 1 pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
3
Number of patients with 2 pregnancies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
2
Number of patients with 3 pregnancies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
3
1.Primary Outcome
Title Intraabdominal Distance (Centimeters)
Hide Description 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).
Time Frame 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Comparisons of changes in distances were performed with paired t-test.
Arm/Group Title Deep Neuromuscular Block No Neuromuscular Block
Hide Arm/Group Description:
Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
Intraabdominal distance during no neuromuscular block
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: centimeters
9.3
(8.6 to 9.6)
9.0
(8.2 to 9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Block, No Neuromuscular Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.07 to 0.59
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Intraabdominal Distance (Centimeters)
Hide Description 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).
Time Frame 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Comparisons of changes in distances were performed with paired t-test
Arm/Group Title Deep Neuromuscular Block No Neuromuscular Block
Hide Arm/Group Description:
Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
Intraabdominal distance during no neuromuscular block
Overall Number of Participants Analyzed 14 14
Median (95% Confidence Interval)
Unit of Measure: centimeters
8.6
(7.7 to 8.9)
8.2
(7.4 to 8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Block, No Neuromuscular Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.06 to 0.54
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Surgical Conditions During Suturing of the Abdominal Fascia
Hide Description Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)
Time Frame 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluation of surgical conditions was compared using Mann–Whitney U-test.
Arm/Group Title Deep Neuromuscular Blockade no Neuromuscular Blockade
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
Optimal (score 1) 7 2
Good (score 2) 0 5
Acceptable (score 3) 0 0
Poor (score 4) 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Deep Neuromuscular Block First Then no Neuromuscular Block No Neuromuscular Block First Then Deep Neuromuscular Block
Hide Arm/Group Description Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade. Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
All-Cause Mortality
Deep Neuromuscular Block First Then no Neuromuscular Block No Neuromuscular Block First Then Deep Neuromuscular Block
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Deep Neuromuscular Block First Then no Neuromuscular Block No Neuromuscular Block First Then Deep Neuromuscular Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Deep Neuromuscular Block First Then no Neuromuscular Block No Neuromuscular Block First Then Deep Neuromuscular Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Matias Vested Madsen
Organization: Herlev Hospital, University of Copenhagen, Department of Anesthesiology
Phone: +4538689058
Responsible Party: Matias Vested Madsen, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01933425     History of Changes
Other Study ID Numbers: NMBDK2013
2013-001164-29 ( EudraCT Number )
First Submitted: August 28, 2013
First Posted: September 2, 2013
Results First Submitted: February 24, 2015
Results First Posted: March 30, 2015
Last Update Posted: March 30, 2015