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

PONV Clinical Trial

— PONV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468323
• Other study ID #: Palonosetron01
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2015
• Last updated: March 8, 2017
• Start date: October 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Hospital de Base
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• PONV

Intervention

Drug:
• Placebo
Patients will receive regular spinal anesthesia
• Ondansetron
Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping
• Palonosetron
Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping

Locations

Country	Name	City	State
Brazil	Hospital de Base do Distrito Federal	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Base

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with nausea and vomiting		Within the first 48 hours after surgery
Secondary	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
Secondary	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
Secondary	Apgar Newborn	The resulting Apgar score ranges from zero to 10, measured at first and fifth minute	delivery
Secondary	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
Secondary	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
Secondary	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