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

NCT02026778 | Completed DMC

• 1 other identifier: 4-2013-0691
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• postoperative nausea and vomiting

  evaluation of nausea and vomiting with verbal rating scale (VRS, 0, no nausea; 10, worst imaginable nausea)

  at postoperative 24h

Study Arms (2)

ondansetron-betahistine

EXPERIMENTAL

ondansetron-betahistine group

Drug: ondansetron-betahistine

ondansetron

PLACEBO COMPARATOR

ondansetron group

Drug: ondansetron

Interventions

ondansetron 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

ondansetron-betahistine 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.

ondansetron-betahistine

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for elective gynecological laparoscopic surgery
• American society of Anesthesiologists physical class I, Ⅱ, between the ages of 20 and 70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 3, 2014
• Study Start: December 1, 2013
• Primary Completion: November 11, 2014
• Study Completion: November 11, 2014
• Last Updated: March 28, 2019

Record last verified: 2015-05

Locations

KR (1)