The Muscle Relaxation-study
This study has been completed.
Sponsor:
Herlev Hospital
Information provided by (Responsible Party):
Anne Kathrine Staehr, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01523886
First received: January 19, 2012
Last updated: November 19, 2012
Last verified: November 2012
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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:
- 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.
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: | 48 |
| 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
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, Clinical research assistent, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01523886 History of Changes |
| Other Study ID Numbers: | 2011-441 |
| Study First Received: | January 19, 2012 |
| Last Updated: | November 19, 2012 |
| 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 May 22, 2013