Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no study that addresses women aged over 60 years.

In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis of PONV.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Federal de Bonsucesso
• Treatments: Antiemetics; Ondansetron; Palonosetron

Criteria

Inclusion Criteria:

• Will be selected patients aged over 60 years, ASA 1-3 that are candidates for laparoscopic cholecystectomy

Exclusion Criteria:

• Participation in another study last month.

• Body mass index> 35.

• The occurrence of episodes of nausea or vomiting in the last 24 h prior to surgery.

• Use of corticosteroids.

• Smoking.

• Alcoholism.

• Use of psychoactive drugs or any other drug with antiemetic effect.

• Known hypersensitivity to any study medication

• Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow.

• Conversion laparoscopic cholecystectomy for conventional cholecystectomy.