NCT06254131

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.

Detailed description

Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV). PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost. The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults. Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects

Conditions

• Ondansetron Lozenge
• Postoperative Nausea and Vomiting
• Caesarean Section

Interventions

Type	Name	Description
DRUG	Ondansetron lozenge (Ondalenz ©)	Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
DRUG	Ondansetron IV	Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery.

Timeline

• Start date: 2024-02-10
• Primary completion: 2024-10-05
• Completion: 2024-10-05
• First posted: 2024-02-12
• Last updated: 2024-10-22

Locations

1 site across 1 country: Egypt