Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy
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StatusCompleted
Sponsors
Yonsei University
CLINICAL TRIAL: NCT02026778
BioSeek: NCT02026778
Keywords
Abstract
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.
Dates
| Last Verified: | 04/30/2015 |
| First Submitted: | 12/16/2013 |
| Estimated Enrollment Submitted: | 12/31/2013 |
| First Posted: | 01/02/2014 |
| Last Update Submitted: | 03/26/2019 |
| Last Update Posted: | 03/27/2019 |
| Actual Study Start Date: | 11/30/2013 |
| Estimated Primary Completion Date: | 11/10/2014 |
| Estimated Study Completion Date: | 11/10/2014 |
Condition or disease
Nausea and Vomiting
Intervention/treatment
Drug: ondansetron
Drug: ondansetron-betahistine
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: ondansetron-betahistine ondansetron-betahistine group | 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. |
| Placebo Comparator: ondansetron ondansetron group | 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. |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. postoperative nausea and vomiting [at postoperative 24h]
evaluation of nausea and vomiting with verbal rating scale (VRS, 0, no nausea; 10, worst imaginable nausea)
