Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy (SALC)
Recruitment status was Recruiting
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Purpose
The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.
| Condition | Intervention |
|---|---|
|
Spinal Anesthesia General Anesthesia Postoperative Pain |
Procedure: laparoscopic cholecystectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients |
- postoperative pain [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
- complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- hospital stay [ Time Frame: time from intervention to discharge ] [ Designated as safety issue: No ]
- patient satisfaction [ Time Frame: within 2 weeks from intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Laparoscopic cholecystectomy under spinal anesthesia
|
Procedure: laparoscopic cholecystectomy
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
|
|
Active Comparator: 2
Laparoscopic cholecystectomy under general anesthesia
|
Procedure: laparoscopic cholecystectomy
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
|
Detailed Description:
Laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. Regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. Surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. It is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. This statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of CO2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. However, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. We have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure CO2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. We have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. After this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- elective laparoscopic cholecystectomy
- ASA I, II
- BMI< 30
- normal coagulation profile
Exclusion Criteria:
- acute cholecystitis / cholangitis / pancreatitis
- previous open surgery in the upper abdomen
- contraindication for pneumoperitoneum
- contraindication for spinal anesthesia (ie spinal deformity)
Contacts and Locations| Contact: George Tzovaras, MD | +30 2410 682730 | gtzovaras@hotmail.com |
| Greece | |
| University Hospital of Larissa | Recruiting |
| Larissa, Thessaly, Greece, 411 10 | |
| Contact: George Tzovaras, MD +30 2410 682730 gtzovaras@hotmail.com | |
| Principal Investigator: Frank Fafoulakis, MD | |
| Sub-Investigator: George Vretzakis, MD | |
| Sub-Investigator: Georgia Stamatiou, MD | |
| Sub-Investigator: Konstantinos Pratsas, MD | |
| Sub-Investigator: Stavroula Georgopoulou, MD | |
| Sub-Investigator: Efi Petinaki, MD | |
| Study Chair: | Constantine Hatzitheofilou, MD | University of Thessaly, School of Medicine |
| Study Director: | George Tzovaras, MD | University of Thessaly, School of Medicine |
| Principal Investigator: | Frank Fafoulakis, MD | University Hospital of Larissa |
More Information
Publications:
| Responsible Party: | George Tzovaras, MD, University of Thessaly, School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00492453 History of Changes |
| Other Study ID Numbers: | UThessaly 9-04 |
| Study First Received: | June 26, 2007 |
| Last Updated: | January 13, 2010 |
| Health Authority: | Greece: Ministry of Health and Welfare |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013