Dexamethasone for Postoperative Nausea and Vomiting

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Ondansetron; Drug: normal saline; Drug: Dexamethasone

• Registration Number: NCT00825071
• Lead Sponsor: University of Jordan

Brief Summary

The investigators want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.

Detailed Description

More than half of the patients undergoing laparoscopic cholecystectomy will have postoperative nausea and vomiting (PONV). PONV is related to surgical, anesthetic and patient factors.

We want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of PONV in patients undergoing laparoscopic cholecystectomy.

Three groups to be studied : (Group O) will receive 4 mg ondansetron, (Group D) will receive 8 mg dexamethasone and (Group P) will receive normal saline .

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-19
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• (ASA) grade I and II, aged (18-70 years) who are scheduled for elective laparoscopic cholecystectomy under general anesthesia at the department of Anesthesia and Intensive Care, University of Jordan, Amman, Jordan between November 2007 and March 2008

Exclusion Criteria

• All patients who received antiemetics or cortisone within 48 hr before surgery or those who required opioids before and after surgeries
• Pregnant, breast feeding ladies
• Any patient with BMI (Body Mass Index) > 34 kg/m²
• Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses or those with history of motion sickness were also excluded from the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group O	Ondansetron	Ondansetron Group: received 4 mg ondansetron
Group P	normal saline	(Group P) received normal saline (Placebo)
Group D	Dexamethasone	Dexamethasone group : This group received 8 mg dexamethasone

Primary Outcome Measures

Name	Time	Method
incidence of nausea and vomiting in each of the three studied groups.	5 months

Secondary Outcome Measures

Name	Time	Method
Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups	5 months

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan