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

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled

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

Study Overview

• Status: Completed
• Conditions: PONV
• Intervention / Treatment: Drug: Ondansetron; Drug: Palonosetron; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • DF
    • Brasilia, DF, Brazil, 70680250
      • Hospital de Base do Distrito Federal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo group; Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of saline 0,9%.	Drug: Ondansetron; Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping; Drug: Palonosetron; Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping
EXPERIMENTAL: Ondansetron group; Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of ondansetron after cord clamping.	Drug: Palonosetron; Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping; Drug: Placebo; Patients will receive regular spinal anesthesia; Other Names: Saline
EXPERIMENTAL: Palonosetron group; Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of palonosetron after cord clamping.	Drug: Ondansetron; Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping; Drug: Placebo; Patients will receive regular spinal anesthesia; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with nausea and vomiting	Within the first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea Scores on the Number Rating Scale	Quantify nausea by Number Rating Scale (NRS, ranging from 0 to 10 cm, zero being found when the patient is no nausea and ten, with maximum or un bearable nausea	Within the first 48 hours after surgery
Nausea Scores on the Verbal Rating Scale	Verbal Rating Scale (VRS), consisting of a list of phrases (no nausea, mild nausea, moderate nausea, intense nausea, maximum nausea)	Within the first 48 hours after surgery
Apgar Newborn	The resulting Apgar score ranges from zero to 10, measured at first and fifth minute	delivery
Likert Scale	Overall satisfaction with the nausea - vomiting experience in a Likert scale of four points (dissatisfied, neutral, satisfied and very satisfied)	48 hours after surgery
Number of participants with adverse events as a measure of safety and tolerability	Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors	delivery
Number of participants with adverse events as a measure of safety and tolerability	Incidence of adverse effects such as nausea, vomiting, pruritus, urinary retention, drowsiness and consumed rescue antiemetics	Within the first 48 hours after surgery

Collaborators and Investigators

• Sponsor: Hospital de Base

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: June 7, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (ESTIMATE): June 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cesarean section; Ondansetron; PONV; Palonosetron
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Palonosetron; Ondansetron
• Other Study ID Numbers: Palonosetron01