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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02026778

Enrollment

168

Registered

2014-01-03

Start date

2013-12-31

Completion date

2014-11-11

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting

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.

Interventions

DRUGondansetron-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.

DRUGondansetron

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026