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

NCT07201883 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MGH-07-25038
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Nausea and Vomiting (PONV)

Keywords

PONV; Ondansetron; Postoperative Period; Vomiting; Laparoscopy; Antiemetics

Outcome Measures

Primary Outcomes (1)

• Complete cessation of PONV with no recurrence and no rescue medication

  2 hours

Secondary Outcomes (2)

• Patient satisfaction

  post-operative period ( up to 3 hours)

• Quantity of rescue treatment modalities used

  immediately after PONV start until complete resolution of symptoms

Study Arms (3)

Ondansetron

ACTIVE COMPARATOR

Drug: Ondansetron (Zofran)

Chewing Gum

EXPERIMENTAL

Other: chewing gum

Ondansetron + Chewing Gum

SHAM COMPARATOR

Combination Product: Ondansetron + Chewing gum

Interventions

Ondansetron (Zofran) DRUG

4 mg IV push

Ondansetron

chewing gum OTHER

Peppermint sugar free chewing gum

Chewing Gum

Ondansetron + Chewing gum COMBINATION_PRODUCT

Ondansetron 4 mg IV push Peppermint sugar free chewing gum

Ondansetron + Chewing Gum

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Related Publications (1)

• Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.

  PMID: 2286697 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Ondansetron; Chewing Gum

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; 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; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Anesthesia Department

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: October 1, 2025
• Study Start: August 22, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)