Clinical trial NCT02468323: Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia
Official title: Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PONV
Keywords: PONV
Palonosetron
Ondansetron
Cesarean section
Lead sponsor: Hospital de Base
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section

Detailed description: Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and remains high despite the emergence of new antiemetic drugs.

Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and rehospitalization which can result in significant increase in overall costs of health care.

The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the patient, improve the quality and safety of surgical procedure and reduce hospital costs.

Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new and potent drug generation5 second-HT antagonist with improved profile that acts longer. Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans comparing the two drugs.

This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea and vomiting in patients undergoing cesarean delivery under spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class I or II
* Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil

Exclusion Criteria:

* patients who had received antiemetics, diabetic, allergic to any study drug, corticosteroid use, psychoactive drugs, patients with vomiting in the course of gastrointestinal disease, eclampsia, heart disease, smokers, any evidence of fetal distress, psychiatric disease or who refused to participate.

Primary outcomes:
measure: Number of participants with nausea and vomiting
timeFrame: Within the first 48 hours after surgery
Secondary outcomes:
measure: Nausea Scores on the Number Rating Scale
timeFrame: Within the first 48 hours after surgery
measure: Nausea Scores on the Verbal Rating Scale
timeFrame: Within the first 48 hours after surgery
measure: Apgar Newborn
timeFrame: delivery
measure: Likert Scale
timeFrame: 48 hours after surgery
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: delivery
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Within the first 48 hours after surgery
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital de Base do Distrito Federal
state: DF
Study officials:
affiliation: Hospital de Base do Distrito Federal
name: Fabricio T Mendonca, MD, TSA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chattopadhyay S, Goswami S. Palonosetron Versus Ramosetron Prophylaxis for Control of Postoperative Nausea and Vomiting after Cesarean Delivery under Spinal Anesthesia. J Obstet Gynaecol India. 2015 Feb;65(1):28-33. doi: 10.1007/s13224-014-0612-6. Epub 2014 Oct 7.