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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

January 19, 2012
March 16, 2014
March 2012
November 2012   (final data collection date for primary outcome measure)
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.
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 (4-stage scale) assessed at the time during surgery, when they were poorest.
Complete list of historical versions of study NCT01523886 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Muscle Relaxation-study
Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Cholecystectomy, Laparoscopic
  • 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
  • Drug: Rocuronium
    Intravenous use: 0,3 mg/kg followed by NaCl-infusion
    Other Name: Esmeron
  • Active Comparator: Deep neuromuscular blockade
    Intervention: Drug: Rocuronium
  • Placebo Comparator: Moderate neuromuscular blockade
    Intervention: Drug: Rocuronium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01523886
2011-441
Yes
Anne Kathrine Staehr-Rye, Herlev Hospital
Herlev Hospital
Not Provided
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
Herlev Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP