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临床试验/NCT03973411
NCT03973411Unknown4 期

Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial

Hospital de Base1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Number of participants with adverse events as hypotension

研究概览

简要总结

Ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic. The main objective of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension

详细描述

Spinal anesthesia is usually the first choice for many surgical procedures of lower limbs, perineum, and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia.

Hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers. The Bezold-Jarisch reflex, proposed as a mechanism for bradycardia is mediated by serotonin receptors (subtype 5-HT3) located in the vagus nerve and within the walls of the cardiac ventricles. 5-HT3 receptors are activated in response to systemic hypotension, causing increased vagal efferent signaling, bradycardia, reduced cardiac output and increased exacerbation of hypotension.

Therefore, ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic, is potentially useful in attenuating this response. To assess this response, the main goal of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension.

This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that blocking serotonin type 3 receptors with intravenous ondansetron prior to subarachnoid block reduces hypotension induced by spinal anesthesia in surgical procedures at Base Hospital of the Federal District. The examiners responsible for patient assessment will not have access to the agents used.

Patients will be randomized through a randomly generated list. The examiner responsible for opening the envelope will make the draw, will include the patient in one of the groups, write down their data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the next examiners will not be aware of the administered drug.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 70 years, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
  • Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)

排除标准

  • Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
  • Patients with atrioventricular block
  • Patients with cardiac arrhythmias
  • Patients with heart failure;
  • Patients with renal disease
  • Patients with liver disease
  • Patient carrying or suspecting any type of systemic infection or located in a puncture site;
  • Patients who refuse to participate in the study after presenting the free and informed consent form;

研究组 & 干预措施

Ondansetron group

Active Comparator

Patients will receive intravenous ondansetron before spinal anesthesia

干预措施: Prophylactic ondansetron (Drug)

Control group

Placebo Comparator

Patients will receive intravenous saline before spinal anesthesia

干预措施: Placebo (Drug)

结局指标

主要结局

Number of participants with adverse events as hypotension

时间窗: During surgery

Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors

次要结局

未报告次要终点

研究者

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

Fabricio Tavares Mendonca

Preceptor of medical residency in anesthesiology

Hospital de Base

研究点 (1)

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