At a glance
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Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy
In Brief
A Phase 4 clinical trial evaluating Ondansetron and Palonosetron for Postoperative Nausea and Vomiting. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.
75 mcg IV, one minute before the anesthesia induction.