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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07201883
Enrollment
90
Registered
2025-10-01
Start date
2025-08-22
Completion date
2026-02-28
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting (PONV)

Keywords

PONV, Ondansetron, Postoperative Period, Vomiting, Laparoscopy, Antiemetics

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.

Interventions

4 mg IV push

OTHERchewing gum

Peppermint sugar free chewing gum

COMBINATION_PRODUCTOndansetron + Chewing gum

Ondansetron 4 mg IV push Peppermint sugar free chewing gum

Sponsors

Makassed General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Complete cessation of PONV with no recurrence and no rescue medication2 hours

Secondary

MeasureTime frame
Patient satisfactionpost-operative period ( up to 3 hours)
Quantity of rescue treatment modalities usedimmediately after PONV start until complete resolution of symptoms

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026