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

NCT02026778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-03-28

No results posted yet for this study

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.

Conditions

  • Nausea and Vomiting

Interventions

DRUG

ondansetron

The ondansetron group is given placebo (pyridoxin) instead of betahistine. The ondansetron group is given ondansetron 4 mg bolus at the end of surgery and ondansetron 8 mg added to the IV-PCA.

DRUG

ondansetron-betahistine

The ondansetron-betahistine group is given betahistine 18mg orally in the morning of surgery and postoperative day 1. The ondansetron-betahistine group is given ondansetron 4 mg bolus at the end of surgery and ondansetron 8 mg added to the IV-PCA.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-11-11
Completion
2014-11-11

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02026778 on ClinicalTrials.gov