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NCT Number: NCT07201883

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Postoperative Nausea and Vomiting (PONV) Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron (Zofran)

Drug

4 mg IV push

Chewing Gum

Other

Peppermint sugar free chewing gum

Ondansetron + Chewing gum

Combination Product

Ondansetron 4 mg IV push Peppermint sugar free chewing gum

Primary outcomes

  1. Complete cessation of PONV with no recurrence and no rescue medication

    Time frame: 2 hours

Secondary outcomes

  1. Patient satisfaction

    Time frame: post-operative period ( up to 3 hours)

  2. Quantity of rescue treatment modalities used

    Time frame: immediately after PONV start until complete resolution of symptoms

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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