Comparison Of Palonosetron Versus Palonosetron With Dexamethasone In Prevention Of Postoperative Nausea And Vomiting After laparoscopic Cholecystectomy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Primary objectives of this study is to assess the efficacy of monotherapy(palonosetron) vs combination therapy(palonosetron – dexamethasone) in preventing postoperative nausea and vomiting
Study Overview
Brief Summary
â— Post-operative nausea and vomiting (PONV) is the second most common complaint in post-operative period after pain.
◠Although nausea and vomiting in post-operative period was reported to occur in 20%–30% of all laparoscopic surgeries and especially laparoscopic cholecystectomy significantly increases the incidence of PONV to as high as 50%.
â— Palonosetron is a second-generation 5-HT3 receptor antagonist having greater receptor binding affinity with a half-life of 40 h
â— Most of the literature and recent guidelines favours the use of dexamethasone and palonosetron, some studies differ in opinion.
In this context, we hypothesised that the combination of palonosetron and dexamethasone will be better antiemetic for PONV prophylaxis than the individual medication and this study was planned to accept or reject that hypothesis.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American Society of Anaesthesiologist Grade 1 & 2 Age between 18 and 60 years Patients posted for laparoscopic cholecystectomy.
Exclusion Criteria
- •not willing to give consent age less than 18 yrs and more than 60yrs history of allergy to palonsetron and dexamethasone electrolyte abnormalities patient with drug history of SSRI and drugs which cause QT prolongation.
Outcomes
Primary Outcomes
Primary objectives of this study is to assess the efficacy of monotherapy(palonosetron) vs combination therapy(palonosetron – dexamethasone) in preventing postoperative nausea and vomiting
Time Frame: 2 years
Secondary Outcomes
- Secondary objective is to study the number of rescue doses of antiemetics needed.(2 years)
Investigators
Dr Kondamuru Likhitha
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation