NCT02468323

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hospital de Base · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section

Detailed description

Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and remains high despite the emergence of new antiemetic drugs. Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and rehospitalization which can result in significant increase in overall costs of health care. The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the patient, improve the quality and safety of surgical procedure and reduce hospital costs. Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new and potent drug generation5 second-HT antagonist with improved profile that acts longer. Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans comparing the two drugs. This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea and vomiting in patients undergoing cesarean delivery under spinal anesthesia.

Conditions

• PONV

Interventions

Type	Name	Description
DRUG	Placebo	Patients will receive regular spinal anesthesia
DRUG	Ondansetron	Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping
DRUG	Palonosetron	Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-06-10
• Last updated: 2017-03-09

Locations

1 site across 1 country: Brazil