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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-22

Study Completion Date

2026-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting (PONV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ondansetron

Group Type ACTIVE_COMPARATOR

Ondansetron (Zofran)

Intervention Type DRUG

4 mg IV push

Chewing Gum

Group Type EXPERIMENTAL

chewing gum

Intervention Type OTHER

Peppermint sugar free chewing gum

Ondansetron + Chewing Gum

Group Type SHAM_COMPARATOR

Ondansetron + Chewing gum

Intervention Type COMBINATION_PRODUCT

Ondansetron 4 mg IV push Peppermint sugar free chewing gum

Interventions

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Ondansetron (Zofran)

4 mg IV push

Intervention Type DRUG

chewing gum

Peppermint sugar free chewing gum

Intervention Type OTHER

Ondansetron + Chewing gum

Ondansetron 4 mg IV push Peppermint sugar free chewing gum

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes