To compare efficacy of prevention of post operative nausea and vomiting between amisulpride and palonosetron in patients undergoing laparoscopic cholecystectomy.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Saloni Das
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- 2. To assess the severity of nausea and vomiting as recorded by PONV score.
Overview
Brief Summary
This is a prospective randomized double blind comparative study in ASA I and II patients aged 18 years or older undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of 244 patients will be randomized into two groups by block randomization. Group AMP will receive intravenous amisulpride 10 mg and Group PLS will receive intravenous palonosetron 75 mcg at induction of anesthesia. Standardized anesthetic technique will be followed for all patients. Postoperative data on nausea, vomiting and retching will be collected at 0 to 2 hours in the recovery room and from 2 to 24 hours in the ward. Rescue antiemetics will be given if PONV score is more than one. Adverse effects related to study drugs and patient satisfaction will also be recorded. Patients converted to open surgery will be withdrawn from the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults of either sex ASA Physical Status I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia.
Exclusion Criteria
- •Patients will be excluded if they refuse consent OR belong to ASA physical status class III or IV OR are undergoing emergency laparoscopic surgery OR are smokers or alcoholics OR are pregnant or lactating OR have a history of postoperative nausea/vomiting or motion sickness OR are allergic to amisulpride or palonosetron OR have significant liver or renal disease OR are already on antiemetics, steroids, or psychomimetic drugs preoperatively OR if the surgery duration is greter than or equal to 3 hours.
Outcomes
Primary Outcomes
2. To assess the severity of nausea and vomiting as recorded by PONV score.
Time Frame: 10 MONTHS
1. To compare the incidence of nausea, vomiting and retching during post-operative 24 hrs in patients undergoing laparoscopic cholecystectomy.
Time Frame: 10 MONTHS
3. The number and timing of doses of rescue antiemetic used during post op 24 hrs
Time Frame: 10 MONTHS
Secondary Outcomes
- To compare:(1. patient satisfaction score and)
Investigators
Dr Saloni Das
IMS & SUM Hospital