Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy

Not Applicable

Completed

• Conditions: Nausea and Vomiting
• Interventions: Drug: ondansetron-betahistine; Drug: ondansetron

• Registration Number: NCT02026778
• Lead Sponsor: Yonsei University

Brief Summary

Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as ondansetron. Involvement of multiple types of receptors and factors may be a reason for inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1 receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness is one of the cause of nausea and vomiting. This study is to compare the effects of ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological laparoscopic surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2014-01-01
• Study First Posted: 2014-01-03
• Primary Completion: 2014-11-11
• Study Completion: 2014-11-11
• Status Verified: 2015-05
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Patient scheduled for elective gynecological laparoscopic surgery
• American society of Anesthesiologists physical class I, Ⅱ, between the ages of 20 and 70 years

Exclusion Criteria

• hepatorenal disease
• BMI > 35 kg/m2
• allergy to ondansetron or betahistine
• gastrointestinal disease
• vomiting within 24h
• administration of antiemetics or opioids within 24h
• QT prolongation (QTc > 440ms)
• Pheochromocytoma
• pregnant
• problem with communication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ondansetron-betahistine	ondansetron-betahistine	ondansetron-betahistine group
ondansetron	ondansetron	ondansetron group

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	at postoperative 24h	evaluation of nausea and vomiting with verbal rating scale (VRS, 0, no nausea; 10, worst imaginable nausea)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of