NCT04069078已完成4 期
Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial
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
- 173
- 试验地点
- 1
- 主要终点
- Bradycardia
研究概览
简要总结
The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status class I-II.
- •Age: 18 Years to 40 Years.
- •Women scheduled for elective Cesarean section under spinal anesthesia.
- •indications for CS other than fetal or maternal pathology.
排除标准
- •Height < 150 or > 180 cm
- •Body mass index (BMI) >35 kg/m2
- •Contraindication for central neuraxial block
- •Refusal to undergo regional anesthesia
- •Known allergy to any of the study drugs,
- •Infection at the site of injection,
- •Coagulopathy,
- •Indication to general anesthesia
- •Baseline bradycardia (heart rate < 60/min), or any cardiovascular disease
- •Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs.
- •Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block,
- •Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy,
- •Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
研究组 & 干预措施
Hyoscine butylbromide
Active Comparator
干预措施: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule (Drug)
Control
Placebo Comparator
干预措施: Normal saline (Other)
结局指标
主要结局
Bradycardia
时间窗: intraoperative
number of participants who will develop heart rate below 50 BPM.
次要结局
未报告次要终点
研究者
Mostafa Samy Abbas
associate professor of anesthesia
Assiut University
研究点 (1)
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