Overview

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.