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:
Participant gender:
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.