Phase 4
N=49
The Muscle Relaxation-study
Cholecystectomy, Laparoscopic
Bottom Line
View on ClinicalTrials.gov: NCT01523886 ↗Enrolled (actual)
49
Serious AEs
8.3%
Results posted
Apr 2014
Primary outcome: Primary: 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 — 28; 4 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rocuronium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Herlev Hospital
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
28; 4 | — |
| SECONDARY Surgical Space Conditions |
— | — |
| SECONDARY Surgical Space Conditions |
— | — |
| SECONDARY Surgical Space Conditions |
— | — |
| SECONDARY Pain |
— | — |
| SECONDARY Pain |
— | — |
| SECONDARY Normal Functional Level |
— | — |
| SECONDARY Surgical Procedures at Low Pneumoperitoneum |
— | — |
| SECONDARY Duration of Surgery |
— | — |
| SECONDARY Duration of Anesthesia |
— | — |
| SECONDARY Consumption of Analgesics |
— | — |
| SECONDARY Nausea and Vomiting |
— | — |
| SECONDARY Anti-emetics |
— | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01523886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.