Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02956252|
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
|Condition or disease||Intervention/treatment|
|Cholecystitis Gallbladder Diseases||Procedure: Spinal anesthesia Procedure: General anesthesia|
Laparoscopic cholecystectomy (LC) is the gold standard surgical treatment of symptomatic cholecystectomy which traditionally performed under general anesthesia. Laparoscopy has provided many advantages over open surgery for the patients; however, general anesthesia adversely affects patients' early postoperative quality of life (POQoL).
Spinal anesthesia which is a less invasive technique compared to general anesthesia has many advantages regarding the POQoL such as no need to wait for recovery from anesthesia, less nausea and vomiting, less or no pain at the end of surgery, no discomfort associated with intubation, early ambulation, fully awaken and oriented patient in the bed, and less anxious relatives.
LC has been shown to be feasible under spinal anesthesia if performed with proper technique. There are many reports demonstrated the effectiveness and safety of LC under spinal anesthesia in selected patients. However, patients with complicated gallstone disease such as acute, gangrenous or subacute cholecystitis have been considered as unfit cases for LC under spinal anesthesia because of technical difficulties. On the other hand, spinal anesthesia has also been regarded as inappropriate for patients complying with American society for anesthesiology (ASA) III and IV due to the uncontrolled anesthesia risks.
The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent LC under spinal versus general anesthesia. If proportion of general anesthesia (PGA) / proportion of spinal anesthesia (PSA) denotes the proportion rate of outcomes in the general anesthesia group (GaG) / spinal anesthesia group (SaG), then two-sided test problem is assessed as follow:
- Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes.
- Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.
|Study Type :||Observational|
|Actual Enrollment :||1500 participants|
|Official Title:||Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||August 2016|
Spinal anesthesia group
patients underwent laparoscopic cholecystectomy under spinal anesthesia
Procedure: Spinal anesthesia
Spinal anesthesia was used in patients who underwent LC
Patients underwent laparoscopic cholecystectomy under general anesthesia
Procedure: General anesthesia
General anesthesia was used in patients who underwent LC
- Change in pain level for the first day [ Time Frame: from baseline to postoperative 1, 2, 4 and 6 hours ]Numerical rating scale (NRS) was used
- Change in pain level for the first month [ Time Frame: From postoperative 1 week to 1 month ]Numerical rating scale was used
- Complications [ Time Frame: within the postoperative 1 month ]All types of complications were assessed
- Mortality [ Time Frame: within the postoperative 1 month ]all causes of mortality were recorded
- Gastrointestinal quality of life index [ Time Frame: change from baseline to postoperative 1 week and 1 month ]A standard form was used under the supervision of experienced independent personal
- Patient satisfaction [ Time Frame: at postoperative 1 month ]a verbal or visual scale was used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956252
|Principal Investigator:||Mehmet Kaplan, M.D.||Bahcesehir University, BAU|