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

Yonsei University

Status: Completed

Conditions: Nausea and Vomiting

Treatments: Drug: ondansetron-betahistine; Drug: ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02026778

4-2013-0691

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups, including a placebo group

ondansetron-betahistine

Experimental group

Description:

ondansetron-betahistine group

Treatment:

Drug: ondansetron-betahistine

ondansetron

Placebo Comparator group

Description:

ondansetron group

Treatment:

Drug: ondansetron