drugset / Trial / NCT06043336

Palonosetron vs Combination of Granisetron and Dexamethasone in Preventing PONV in Laparoscopic Cholecystectomy.

NCT06043336

Phase 4 Completed 134 enrolled Universiti Kebangsaan Malaysia Medical Centre
RandomizedParallel-groupSingle-blindPrevention

Summary

This is a prospective, randomized, double-blinded study comparing the post-operative nausea vomiting (PONV) profile following administration of intraoperative palonosetron alone and the combination of granisetron and dexamethasone in moderate to high-risk patients undergoing elective laparoscopic cholecystectomy. Patients aged 18-65 years with American Society of Anesthesiologists physical status I or II were randomized into two groups. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery. The occurrence of PONV and the need for rescue antiemetics were assessed at 30 minutes, 4, 24 and 48 hours post-anesthesia. A complete response towards the study drugs was considered when patients did not experience PONV and did not require rescue antiemetics. The side effects of the study drugs were evaluated. Patient satisfaction with the anti-emetics administered was assessed. These parameters were compared between Group A and Group B: the occurrence of PONV, the need of rescue antiemetics, the side effects of the study drugs and patient satisfaction with the anti-emetics administered.

Timeline

Start
2018-05-10
Primary completion
2019-05-10
Completion
2019-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg Intravenous
Subject Granisetron Other / unclassified 1 mg Intravenous
Subject Palonosetron Other / unclassified 0.075 mg Intravenous

Indications

No indication recorded.