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

Makassed General Hospital

Status and phase: Active, not recruiting; Phase 1

Conditions: Postoperative Nausea and Vomiting (PONV)

Treatments: Combination Product: Ondansetron + Chewing gum; Other: chewing gum; Drug: Ondansetron (Zofran)

Study type: Interventional

Funder types: Other

Identifiers

NCT07201883

MGH-07-25038

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Ondansetron

Active Comparator group

Treatment:

Drug: Ondansetron (Zofran)

Chewing Gum

Experimental group

Treatment:

Other: chewing gum

Ondansetron + Chewing Gum

Sham Comparator group

Treatment:

Combination Product: Ondansetron + Chewing gum