Compare Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

BACKGROUND: Palonosetron is a second generation serotonin antagonist usually used in a fixed dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are a few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose for obese patients has not yet been investigated. The aim of this study is to evaluate if the use of bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose (75mcg) on preventing postoperative nausea and vomiting in female patients with a body mass index equal to or above 30 kg /m2 whom have undergone breast surgery METHODS: A prospective, randomized double-blind trial will be conducted at the National Cancer Institute (INCA - HCIII), in Rio de Janeiro, Brazil. Eligible patients are female aged between 18-70 years of age with an ASA physical status of one to three, with body mass index equal to or greater than 30 kg / m2, scheduled to undergo elective breast surgery. Forty patients will be randomized to receive a fix dose of 75 μg of palonosetron (group I - GI) and 40 patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII). Patients will be assessed over 3 time periods: 0-6 h, 6-26 h and 24-48 h after surgery. After discharge, all patients will be contacted by telephone at regular intervals to record the episodes of nausea and vomiting as well as analgesic and antiemetic requirements. The primary outcome measure will include the number of emetic episodes, the incidence of nausea, the need for rescue antiemetics and the analgesic requirement over 48h. The secondary outcome will be to evaluate the frequency of polymorphism of the 5-HT3 receptors and their correlation with the antiemetic effect and adverse effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil
• Treatments: Palonosetron

Criteria

Inclusion Criteria:

• female

• aged 18-70 years

• ASA physical status of one to three

• body mass index equal to or greater than 30 kg / m2

• scheduled to undergo elective breast surgery

Exclusion Criteria:

• patients who had received chemotherapy within 4 weeks,

• patients who have undergone emergency surgery,

• history of vomiting within 24 hours;

• hypersensitivity to other 5-HTantagonists,

• patients who received any antiemetic, corticosteroid, or other drug with antiemetic effect,

• smokers

• history of alcoholism.