Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia

NCT ID: NCT02468323

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-02-28

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.

Conditions

PONV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of saline 0,9%.

Group Type: PLACEBO_COMPARATOR

Ondansetron

Intervention Type: DRUG

Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping

Palonosetron

Intervention Type: DRUG

Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping

Ondansetron group

Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of ondansetron after cord clamping.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Patients will receive regular spinal anesthesia

Palonosetron

Intervention Type: DRUG

Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping

Palonosetron group

Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of palonosetron after cord clamping.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Patients will receive regular spinal anesthesia

Ondansetron

Intervention Type: DRUG

Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping

Interventions

Placebo

Patients will receive regular spinal anesthesia

Intervention Type: DRUG

Ondansetron

Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping

Intervention Type: DRUG

Palonosetron

Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping

Intervention Type: DRUG

Other Intervention Names

Saline

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Base

OTHER

Sponsor Role: lead

Responsible Party

Fabricio Tavares Mendonca

MD, TSA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabricio T Mendonca, MD, TSA

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base do Distrito Federal

Locations

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 25737619 (View on PubMed)

Other Identifiers

Palonosetron01

Identifier Type: -

Identifier Source: org_study_id