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

Primary Purpose

Nausea and Vomiting

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ondansetron

ondansetron-betahistine

About this trial

This is an interventional prevention trial for Nausea and Vomiting

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ondansetron-betahistine

ondansetron

Arm Description

ondansetron-betahistine group

ondansetron group

Outcomes

Primary Outcome Measures

postoperative nausea and vomiting

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02026778

First Posted

December 17, 2013

Last Updated

March 27, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02026778

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

November 11, 2014 (Actual)

Study Completion Date

November 11, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea and Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ondansetron-betahistine

Arm Type

Experimental

Arm Description

ondansetron-betahistine group

Arm Title

ondansetron

Arm Type

Placebo Comparator

Arm Description

ondansetron group

Intervention Type

Drug

Intervention Name(s)

ondansetron

Intervention Description

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

Intervention Name(s)

ondansetron-betahistine

Intervention Description

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.

Primary Outcome Measure Information:

Title

postoperative nausea and vomiting

Description

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

Time Frame

at postoperative 24h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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