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Completed

NCT Number: NCT01523886

The Muscle Relaxation-study

The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.

The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.

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Key information

Conditions

Cholecystectomy, Laparoscopic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet

Soeborg, 2860, Denmark

About this study

The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18 years
  • Scheduled for elective laparoscopic cholecystectomy
  • Can read and understand danish
  • Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion criteria

  • Known allergy to medications that are included in the project
  • Presence of severe renal disease, neuromuscular disease, reduced liver function
  • Nursing or pregnant
  • Indication for crash induction
  • For fertile women: Missing negative pregnancy-test

Treatment and study plan

Rocuronium

Drug

Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h

Other names: Esmeron

Primary outcomes

  1. The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less

    Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes

    The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.

Secondary outcomes

  1. Surgical Space Conditions

    Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.

    The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest

  2. Surgical Space Conditions

    Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.

    The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.

  3. Surgical Space Conditions

    Time frame: During dissection of the gallbladder

    The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).

  4. Pain

    Time frame: Preoperatively to 7 days after surgery

    Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.

  5. Pain

    Time frame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery

    Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.

  6. Normal Functional Level

    Time frame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days.

    Numer of days before re-establing normal functional level

  7. Surgical Procedures at Low Pneumoperitoneum

    Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.

    Number of procedures which can be done with pneumoperitoneum 8 mmHg

  8. Duration of Surgery

    Time frame: From surgical incision to last suture has been placed.

    Duration of surgery

  9. Duration of Anesthesia

    Time frame: From induction of anesthesia to patient ready to leave the operating theatre

    Duration of anesthesia

  10. Consumption of Analgesics

    Time frame: The first 24 hours after surgery

    Consumption of analgesics during the first 24 hours after surgery

  11. Nausea and Vomiting

    Time frame: The first 24 hours after surgery

    The incidence of nausea and vomiting during the first 24 hours after surgery

  12. Anti-emetics

    Time frame: During the first 24 hours after surgery

    Use of anti-emetics during the first 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2012
Registry last updated
Apr 21, 2014

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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