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

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

Detailed Description
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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.

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

Conditions
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PONV

Intervention / Treatment
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* Drug: Placebo
* Drug: Ondansetron
* Drug: Palonosetron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, Palonosetron, Ondansetron, Cesarean section