Phase 4
Completed N=49
The Muscle Relaxation-study
Cholecystectomy, Laparoscopic
Source: ClinicalTrials.gov NCT01523886 ↗
Enrolled (actual)
49
Serious AEs
8.3%
Results posted
Apr 2014
Primary outcomePrimary: 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
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.
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 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 |
— | — |
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. Informational only — not medical advice.