Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Phase 2

Completed

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

• Registration Number: NCT01543945
• Lead Sponsor: Prince of Songkla University

Brief Summary

The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2011-12
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-29
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

• Ambulatory gynecologic laparoscopy
• Age 18-45 years
• ASA class 1-2

Exclusion Criteria

• The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery
• History of antiemetic, anesthetic and analgesic drugs allergy
• Pregnancy or breast feeding
• Body mass index >34 kg/square metre

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Ondansetron	Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv
Multimodal antiemetic management group	Dexamethasone	Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
Multimodal antiemetic management group	Dimenhydrinate	Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
Multimodal antiemetic management group	Ondansetron	Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg

Primary Outcome Measures

Name	Time	Method
Incidence of PONV in ambulatory gynecologic laparoscopy	four year

Trial Locations

Locations (1)

Anesthesiology Department, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand