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

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ClinicalTrials.gov Identifier: NCT02468323
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Fabricio Tavares Mendonca, Hospital de Base

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

Condition or disease Intervention/treatment Phase
PONV Drug: Placebo Drug: Ondansetron Drug: Palonosetron Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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: Placebo
Patients will receive regular spinal anesthesia
Other Name: Saline

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

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: Placebo
Patients will receive regular spinal anesthesia
Other Name: Saline

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




Primary Outcome Measures :
  1. Number of participants with nausea and vomiting [ Time Frame: Within the first 48 hours after surgery ]

Secondary Outcome Measures :
  1. Nausea Scores on the Number Rating Scale [ Time Frame: Within the first 48 hours after surgery ]
    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

  2. Nausea Scores on the Verbal Rating Scale [ Time Frame: Within the first 48 hours after surgery ]
    Verbal Rating Scale (VRS), consisting of a list of phrases (no nausea, mild nausea, moderate nausea, intense nausea, maximum nausea)

  3. Apgar Newborn [ Time Frame: delivery ]
    The resulting Apgar score ranges from zero to 10, measured at first and fifth minute

  4. Likert Scale [ Time Frame: 48 hours after surgery ]
    Overall satisfaction with the nausea - vomiting experience in a Likert scale of four points (dissatisfied, neutral, satisfied and very satisfied)

  5. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: delivery ]
    Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors

  6. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Within the first 48 hours after surgery ]
    Incidence of adverse effects such as nausea, vomiting, pruritus, urinary retention, drowsiness and consumed rescue antiemetics



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468323


Locations
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Brazil
Hospital de Base do Distrito Federal
Brasilia, DF, Brazil, 70680250
Sponsors and Collaborators
Hospital de Base
Investigators
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Principal Investigator: Fabricio T Mendonca, MD, TSA Hospital de Base do Distrito Federal
Publications:
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Responsible Party: Fabricio Tavares Mendonca, MD, TSA, Hospital de Base
ClinicalTrials.gov Identifier: NCT02468323    
Other Study ID Numbers: Palonosetron01
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Fabricio Tavares Mendonca, Hospital de Base:
PONV
Palonosetron
Ondansetron
Cesarean section
Additional relevant MeSH terms:
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Ondansetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Serotonin 5-HT3 Receptor Antagonists