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

Not Applicable

Active, not recruiting

• Conditions: Postoperative Nausea and Vomiting (PONV)
• Interventions: Drug: Ondansetron (Zofran); Other: chewing gum; Combination Product: Ondansetron + Chewing gum

• Registration Number: NCT07201883
• Lead Sponsor: Makassed General Hospital

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).

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 Timeline

• Study Start: 2025-08-22
• Study First Submitted: 2025-08-22
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron (Zofran)	-
Chewing Gum	chewing gum	-
Ondansetron + Chewing Gum	Ondansetron + Chewing gum	-

Primary Outcome Measures

Name	Time	Method
Complete cessation of PONV with no recurrence and no rescue medication	2 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon