Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing ERCP

• Status: Not yet recruiting
• Trial end date: 2021-05-25
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the effects of a single dose Ondansetron 4mg versus Palonosetron 75mcg in the prophylaxis against early & delayed postoperative nausea and vomiting in the first 48 hours post-operatively in patients undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to determine the complete response, complete control and failure rates.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theodor Bilharz Research Institute
• Collaborator: Cairo University
• Treatments: Ondansetron; Palonosetron

Criteria

Inclusion Criteria:

• Between 18-60 years of age

• American Society of Anaesthesiologists physical status (ASA) grade I-II

• 1 - 2 Risk factor for PONV according to Apfel Score

o Apfel Score includes 4 points : Female gender, history of PONV and/or motion sickness, non-smoking status, and post-operative use of opioids , the risk of PONV is 10%, 20%, 40%,60% or 80% respectively

• Undergoing elective ERCP.

• Having provided written informed consent signed by patient or guardian.

Exclusion Criteria:

• Allergy to any drug being used in the study

• ASA III-IV

• History of vomiting, retching, nausea or antiemetics use in the 24 hours prior to day of procedure

• Patients receiving steroids, prokinetics, or antacids intake in the previous 48 hours

• Patients with significant gastro-oesophageal disease

• Menstruating, lactating or pregnant females

• History of alcohol or substance abuse

• Significant systemic disease of the liver, kidneys, heart, lungs, Cancer and or diabetes mellitus.