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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ondansetron

ondansetron group

Group Type PLACEBO_COMPARATOR

ondansetron

Intervention Type DRUG

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.

ondansetron-betahistine

ondansetron-betahistine group

Group Type EXPERIMENTAL

ondansetron-betahistine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes