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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Deep Neuromuscular Block First Then no Neuromuscular Block   No Neuromuscular Block First Then Deep Neuromuscular Block
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Females

Reporting Groups
  Description
Patient Characteristics in 14 Women No text entered.

Baseline Measures
   Patient Characteristics in 14 Women 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.2  (7.7) 
Gender 
[Units: Participants]
 
Female   14 
Male   0 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 22.2  (2.6) 
Number of patients with previous abdominal surgery 
[Units: Participants]
 7 
Number of patients with 0 pregnancies 
[Units: Participants]
 6 
Number of patients with 1 pregnancy 
[Units: Participants]
 3 
Number of patients with 2 pregnancies 
[Units: Participants]
 2 
Number of patients with 3 pregnancies 
[Units: Participants]
 3 


  Outcome Measures

1.  Primary:   Intraabdominal Distance (Centimeters)   [ Time Frame: 1 hour ]

2.  Secondary:   Intraabdominal Distance (Centimeters)   [ Time Frame: 1 hour ]

3.  Secondary:   Surgical Conditions During Suturing of the Abdominal Fascia   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: matias.vested.madsen@regionh.dk



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