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临床试验/NCT02468323
NCT02468323已完成4 期

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

Hospital de Base1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Number of participants with nausea and vomiting

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists class I or II
  • Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil

排除标准

  • 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.

研究组 & 干预措施

Placebo group

Placebo Comparator

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

干预措施: Ondansetron (Drug)

Placebo group

Placebo Comparator

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

干预措施: Palonosetron (Drug)

Ondansetron group

Experimental

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

干预措施: Placebo (Drug)

Ondansetron group

Experimental

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

干预措施: Palonosetron (Drug)

Palonosetron group

Experimental

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

干预措施: Placebo (Drug)

Palonosetron group

Experimental

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

干预措施: Ondansetron (Drug)

结局指标

主要结局

Number of participants with nausea and vomiting

时间窗: Within the first 48 hours after surgery

次要结局

  • Nausea Scores on the Number Rating Scale(Within the first 48 hours after surgery)
  • Nausea Scores on the Verbal Rating Scale(Within the first 48 hours after surgery)
  • Apgar Newborn(delivery)
  • Likert Scale(48 hours after surgery)
  • Number of participants with adverse events as a measure of safety and tolerability(Within the first 48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabricio Tavares Mendonca

MD, TSA

Hospital de Base

研究点 (1)

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