NCT00781157已完成4 期
Up-down Determination of the ED90 of Phenylephrine for Spinal Induced Hypotension in Parturients Undergoing Cesarean Delivery
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
- 66
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the ED90 for bolus phenylephrine.
研究概览
简要总结
This study is designed to determine the ED90 for a single dose of phenylephrine for the treatment of spinal induced hypotension in parturients presenting for an elective CD. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-emergent cesarean delivery with planned regional anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
- •American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
- •Age ≥ 18 years (Standard within the obstetrical literature)
- •Term gestational age
- •English-speaking
排除标准
- •Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
- •Height < 5'0" (Women < 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
- •Laboring women
- •Urgent or emergency cesarean delivery
- •Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) > 160mmHg, diastolic blood pressure (DBP) > 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
- •Severe maternal cardiac disease
- •Diabetes type I
- •Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
- •Fetal anomalies
- •Failed spinal anesthesia
- •Subject enrollment in another study involving a study medication within 30 days of CD
- •Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
研究组 & 干预措施
1
Experimental
干预措施: Phenylephrine bolus (Drug)
结局指标
主要结局
The primary outcome measure is the ED90 for bolus phenylephrine.
时间窗: Intraoperative
次要结局
- Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.(Intraoperative)
研究者
Ronald George
Primary Investigator, MD, FRCPC, Assistant Professor
IWK Health Centre
研究点 (1)
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