A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Incidence of hypotension
研究概览
简要总结
Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia
详细描述
Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.
排除标准
- •Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.
研究组 & 干预措施
Group B
This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension
干预措施: Phenylephrine (Drug)
Group A
This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of hypotension
时间窗: within first 24 hours after spinal anesthesia
blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
次要结局
- Ephedrine usage(within first 24 hours after spinal anesthesia)
- Apgar scores(within first 24 hours after spinal anesthesia)
- Frequency of bradycardia(within first 24 hours after spinal anesthesia)
- intraoperative fluid management(within first 24 hours after spinal anesthesia)
研究者
Sayed Kaoud Abd-Elshafy
Associate profossor of anesthesia
Assiut University