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临床试验/NCT05498857
NCT05498857Unknown4 期

Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Prospective, Randomized, Double-blind, Placebo-controlled Trial

Hospital de Base1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2022年7月15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
202
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

Subarachnoid anesthesia is an alternative and usually the first choice for many surgical procedures. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. In this sense, ephedrine, an alpha and beta agonist agent, commonly used as rescue therapy for these events, is also potentially useful for prophylaxis of this unwanted effect and for less hemodynamic variation when preventively administered via the intramuscular route. Two groups will be divided: intramuscular ephedrine (0.5 mg/kg) and placebo. The variables analyzed and compared will be the incidence of hypotension and bradycardia, variation in mean and systolic blood pressure, heart rate, in addition to side effects. The main objective is to verify if the use of intramuscular ephedrine prior to spinal block is able to reduce the incidence of hypotension.

详细描述

Subarachnoid or spinal anesthesia is an alternative and usually the first choice for many surgical procedures of the lower limbs, perineum and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. The incidence of hypotension and bradycardia is approximately 30 and 10%, respectively, during spinal anesthesia, however, the incidence of hypotension can be as high as 50 to 60% in obstetric patients.

In this sense, it is common for ephedrine, an agent with beta and alpha agonist action, to be the medication of first choice for rescuing hypotension and bradycardia after subarachnoid block, with part of its action happening by a direct mechanism and part by stimulus and indirect release. of endogenous catecholamines stored in the adrenal.

It is known that intramuscular administration has slower absorption and lower bioavailability of the drug compared to intravenous administration. Therefore, we have in our favor: a later serum peak, coinciding with the establishment of sympathetic block after spinal anesthesia, as well as more insidious effects, with less tendency to peaks and valleys and greater hemodynamic stability when compared to therapy alone. intravenous rescue. To assess this response, the main objective of the present study is to verify the hypothesis that the previous administration of ephedrine by intramuscular route reduces the incidence of hypotension induced by spinal anesthesia.

The proposal is a prospective, randomized, double-blind, placebo-controlled study in surgical procedures. Examiners responsible for evaluating patients will not have access to the agents used. Patients will be randomized through a list generated by lottery. The examiner responsible for opening the envelope, will perform the drawing, include the patient in one of the groups, write down his/her data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the following examiners will not be aware of the administered drug.

Patients will receive standard monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. Then, the study drug will be administered (ephedrine 0.3mg/kg intramuscularly or placebo). All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist, except clonidine.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years old, 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

Ephedrine group

Active Comparator

Patients will receive intramuscular ephedrine 0,5 mg/kg before spinal anesthesia

干预措施: Intramuscular ephedrine (Drug)

Ephedrine group

Active Comparator

Patients will receive intramuscular ephedrine 0,5 mg/kg before spinal anesthesia

干预措施: Placebo (Drug)

Placebo group

Placebo Comparator

Patients will receive intramuscular saline before spinal anesthesia

干预措施: Intramuscular ephedrine (Drug)

Placebo group

Placebo Comparator

Patients will receive intramuscular 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 of 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

MD, MSc, PhD

Hospital de Base

研究点 (1)

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