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OpenTrials
Completed

NCT Number: NCT01933425

Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital

Copenhagen, Søborg, 2830, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Sugammadex

Drug

Placebo

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. Surgical Conditions During Suturing of the Abdominal Fascia

    Time frame: 1 hour

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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