Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

March 27, 2015 updated by: Matias Vested Madsen, Herlev Hospital

Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Søborg
      • Copenhagen, Søborg, Denmark, 2830
        • Department of minimal invasive gynecology Aleris-Hamlet Private Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients > 18 years old
  • elective laparoscopic operation
  • can read and understand Danish
  • informed consent

Exclusion Criteria:

  • BMI > 30 kg/cm2
  • known allergy to medications that are included in the project,
  • severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis),
  • neuromuscular disease that may interfere with neuromuscular data,
  • lactating or pregnant,
  • impaired liver function,
  • converting to laparotomy,
  • perioperative use of neuromuscular blocking agents before randomization,
  • pneumoperitoneum set to >12 mmHg on the insufflator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deep neuromuscular block followed by 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
Drug: placebo
Drug: sugammadex
Drug: rocuronium
Placebo Comparator: No neuromuscular block followed by 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.
Drug: placebo
Drug: sugammadex
Drug: rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraabdominal Distance (Centimeters)
Time Frame: 1 hour
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).
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraabdominal Distance (Centimeters)
Time Frame: 1 hour
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).
1 hour
Surgical Conditions During Suturing of the Abdominal Fascia
Time Frame: 1 hour
Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Matias Vested Madsen, MD, Department of Anesthesiology Herlev Hospital
  • Study Director: Olav Istre, MD, DMSc, professor, Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMBDK2013
  • 2013-001164-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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