The Muscle Relaxation-study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Kathrine Staehr-Rye, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01523886
First received: January 19, 2012
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cholecystectomy, Laparoscopic
Drug: Rocuronium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Surgical Space Conditions [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ] [ Designated as safety issue: No ]
    The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest

  • Surgical Space Conditions [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ] [ Designated as safety issue: No ]
    The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.

  • Surgical Space Conditions [ Time Frame: During dissection of the gallbladder ] [ Designated as safety issue: No ]
    The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).

  • Pain [ Time Frame: Preoperatively to 7 days after surgery ] [ Designated as safety issue: No ]
    Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.

  • Pain [ Time Frame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery ] [ Designated as safety issue: No ]
    Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.

  • Normal Functional Level [ Time Frame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days. ] [ Designated as safety issue: No ]
    Numer of days before re-establing normal functional level

  • Surgical Procedures at Low Pneumoperitoneum [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ] [ Designated as safety issue: No ]
    Number of procedures which can be done with pneumoperitoneum 8 mmHg

  • Duration of Surgery [ Time Frame: From surgical incision to last suture has been placed. ] [ Designated as safety issue: No ]
    Duration of surgery

  • Duration of Anesthesia [ Time Frame: From induction of anesthesia to patient ready to leave the operating theatre ] [ Designated as safety issue: No ]
    Duration of anesthesia

  • Consumption of Analgesics [ Time Frame: The first 24 hours after surgery ] [ Designated as safety issue: No ]
    Consumption of analgesics during the first 24 hours after surgery

  • Nausea and Vomiting [ Time Frame: The first 24 hours after surgery ] [ Designated as safety issue: No ]
    The incidence of nausea and vomiting during the first 24 hours after surgery

  • Anti-emetics [ Time Frame: During the first 24 hours after surgery ] [ Designated as safety issue: No ]
    Use of anti-emetics during the first 24 hours after surgery


Enrollment: 49
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Deep neuromuscular blockade Drug: Rocuronium
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 Name: Esmeron
Placebo Comparator: Moderate neuromuscular blockade Drug: Rocuronium
Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Other Name: Esmeron

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523886

Locations
Denmark
Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet
Soeborg, Denmark, 2860
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Anne K Staehr, MD Department of anesthesia, Herlev Hospital, Denmark
Study Chair: Mona R Gätke, MD, Ph.D Department of anesthesia, Herlev Hospital
  More Information

No publications provided

Responsible Party: Anne Kathrine Staehr-Rye, Clinical research assistent, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01523886     History of Changes
Other Study ID Numbers: 2011-441
Study First Received: January 19, 2012
Results First Received: January 16, 2014
Last Updated: March 16, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014