N/A
N=50
Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy
Gall Stone Disease · Polyp
Bottom Line
View on ClinicalTrials.gov: NCT02317510 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Duration of Operation — 36.56; 30.75 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- combined anesthesia (Procedure); general anesthesia (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lütfiye Nuri Burat Government Hospital
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Operation |
36.56; 30.75 | — |
| PRIMARY Post-operative Shoulder Pain |
15; 6; 10; 18 | — |
| SECONDARY Duration of Anaesthesia |
60.17; 60.23 | — |
| SECONDARY Post-operative Abdominal Pain 2nd Hour |
7; 1 | — |
| SECONDARY Post-operative Abdominal Pain 4th Hour |
6; 2 | — |
| SECONDARY Post-operative Abdominal Pain 6th Hour |
4; 4 | — |
| SECONDARY Post-operative Abdominal Pain 12th Hour |
3; 1 | — |
| SECONDARY Post-operative Abdominal Pain 24th Hour |
2; 1 | — |
| SECONDARY Intra-operative Shoulder Pain |
0; 3; 25; 21 | — |
| SECONDARY Urinary Retention |
0; 3; 25; 21 | — |
| SECONDARY Nausea/Vomiting |
5; 1; 20; 23 | — |
| SECONDARY Headache |
0; 2; 25; 22 | — |
Summary
The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.
Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.
Eligibility Criteria
Inclusion Criteria
- Gall stone disease, polyp
Exclusion Criteria
- Gall bladder cancer
Data sourced from ClinicalTrials.gov (NCT02317510). 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.