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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

NCT02541019 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-08-09

No results posted yet for this study

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.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Ondansetron

4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.

DRUG

Palonosetron

75 mcg IV, one minute before the anesthesia induction.

Sponsors & Collaborators

  • Hospital Federal de Bonsucesso

    lead OTHER

Principal Investigators

  • Ismar L Cavalcanti, PhD · UFF

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-01-01
Completion
2017-07-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541019 on ClinicalTrials.gov