Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients

September 23, 2025 updated by: Omar Rajab, Makassed General Hospital

A Randomized Clinical Trial; Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients Undergoing Laparoscopic Surgery at a Single Centre in Lebanon

The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Post-operative nausea and vomiting remains a significant complication following general anesthesia, particularly when volatile anesthetics are used. Previous studies, including a multicenter randomized trial conducted in Australia, have explored alternative treatment modalities for PONV. Chewing gum, a non-pharmacological intervention, has shown promise as a potential alternative or adjunct to conventional antiemetics like ondansetron. This study focuses on the Lebanese female population, aged 18 and above, who have undergone laparoscopic surgery under volatile anesthetic-based general anesthesia. This demographic is chosen based on established risk factors for PONV and may offer unique insights into efficacy within this subgroup.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Makassed General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Females
  • Aged 18 and above,
  • Weight 40kg and above,
  • Who have undergone laparoscopic
  • Surgery under volatile anesthetic-based general anesthesia.

Exclusion Criteria:

  • Have history of motion sickness,
  • Maintained anesthesia during surgery using Propofol-pump
  • Were given antiemetics within 8 hours pre-surgery
  • Allergy to ondansetron
  • Planned mechanical ventilation post-operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ondansetron
Drug: Ondansetron (Zofran)
4 mg IV push
Experimental: Chewing Gum
Other: chewing gum
Peppermint sugar free chewing gum
Sham Comparator: Ondansetron + Chewing Gum
Combination product: Ondansetron + Chewing gum
Ondansetron 4 mg IV push Peppermint sugar free chewing gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete cessation of PONV with no recurrence and no rescue medication
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: post-operative period ( up to 3 hours)
post-operative period ( up to 3 hours)
Quantity of rescue treatment modalities used
Time Frame: immediately after PONV start until complete resolution of symptoms
immediately after PONV start until complete resolution of symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makassed General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGH-07-25038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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