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Clinical Trials/CTRI/2024/03/064564
CTRI/2024/03/064564Not yet recruitingNot Applicable

A comparative study of Palonosetron And Granisetron for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgeries.

Dr. Priyanka Prasannan1 site in 1 country60 target enrollmentStarted: April 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Postoperative nausea and vomiting

Study Overview

Brief Summary

Post operative nausea and vomiting along with patient dissatisfaction has many other adverse effects such as delayed recovery and extended hospital stay. The incidence of post operative nausea and vomiting was observed 30% in laparoscopic surgeries is as high as  as 70-80%. Granisetron and palonosetron are selective 5HT3 receptor antagonists that play an important role in the prophylaxis of PONV as they are more efficacious  and have lesser side effects when compared to other antiemetics. Hence the present double blind study to compare the efficacy of palanosetron and granisetron in PONV in laparoscopic surgeries.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA Physical status I and II.
  • Elective Laparoscopic surgeries requiring general anaesthesia with endotracheal intubation and controlled ventilation.
  • Patients willing to give informed consent.

Exclusion Criteria

  • ASA Physical status III and IV.
  • Patients with emetic episodes in the 24 hours prior to surgery.
  • Pregnancy or lactating mothers.
  • Emergency surgeries.
  • Patients with history of smoking or PONV or motion sickness.
  • Patients on medications that cause QT.
  • Prolongation.

Outcomes

Primary Outcomes

Postoperative nausea and vomiting

Time Frame: 0-2 hours, 2-6 hours, 6-24 hours, 24-48 hours

Secondary Outcomes

  • Post-operative vitals(30mins,60mins,90 mins,120 mins,3rd hour,4th hour,5th hour,6th hour,8th hour,12th hour,16th hour,20th hour,24th hour,28th hour,32nd hour,36th hour,40th hour,44th hour,48th hour)

Investigators

Sponsor
Dr. Priyanka Prasannan
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Priyanka Prasannan

BGS Global Institute of Medical Sciences

Study Sites (1)

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