NCT02026778

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-11-11
• Completion: 2014-11-11
• First posted: 2014-01-03
• Last updated: 2019-03-28

Locations

1 site across 1 country: South Korea