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临床试验/NCT04358367
NCT04358367已完成3 期

Intravenous Dexmedetomidine Reduces Hypotension and Epigastric Pain in Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Study

Egyptian Biomedical Research Network1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年5月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
ephedrine use

研究概览

简要总结

The present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain together with satisfactory analgesic effects and excellent safety profile for the mother and the newborn.

详细描述

Background and aim: Hypotension and epigastric pain are commonly encountered during spinal anesthesia for cesarean section. Dexmedetomidine (DEX) is a highly selective α 2-adrenergic agonist. Its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. The present randomized study aimed to evaluate the effect of intravenous DEX administration on the hemodynamic parameters and epigastric pain in women subjected to cesarean section.

Patients and Methods: This study is a randomized double-blinded controlled trial. Seventy patients were randomly assigned to one of two interventional groups: one group received spinal anesthesia and intravenous DEX (1µg/kg) and the other group received spinal anesthesia and placebo (saline). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace. Primary Outcome parameters included frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and epigastric pain episodes. Secondary outcomes included time to onset of sensory and motor blocks, duration of sensory and motor blocks, operative duration, time needed to request of rescue analgesia, level of intrathecal block, and neonatal Apgar score at 1 and 5 minutes.

研究设计

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

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Full-term pregnancy and American Society of Anesthesiologists (ASA) physical status I/II in women scheduled for elective cesarean section

排除标准

  • Severe hepatic or renal disease
  • Severe cardiopulmonary disease
  • Thyroid disorders multiple allergies prematurity
  • Known fatal abnormality
  • Known chronic gastrointestinal problems with epigastric pain e.g. peptic ulcer and reflux esophagitis.

研究组 & 干预措施

Dexmedetomidine

Active Comparator

spinal anesthesia and intravenous dexmedetomidine(1µg/kg)

干预措施: Dexmedetomidine Injectable Product (Drug)

Saline

Placebo Comparator

spinal anesthesia and placebo (saline).

干预措施: Saline (Drug)

结局指标

主要结局

ephedrine use

时间窗: up to 48 hours postoperative

frequency of ephedrine doses needed

epigastric pain

时间窗: up to 48 hours postoperative

Pain in the epigastric region assessed by Visual Analog Scale

sedation

时间窗: up to 48 hours postoperative

sedation score

hypotension

时间窗: up to 48 hours postoperative

systolic blood pressure \< 90 mmHg

次要结局

  • sensory and motor blocks(Intraoperative)

研究者

发起方
Egyptian Biomedical Research Network
申办方类型
Network
责任方
Sponsor

研究点 (1)

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