Intravenous Dexmedetomidine Reduces Hypotension and Epigastric Pain in Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Study
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
- 是
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
spinal anesthesia and intravenous dexmedetomidine(1µg/kg)
干预措施: Dexmedetomidine Injectable Product (Drug)
Saline
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)
