ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percent of successful blocks for operation (success operation)
研究概览
简要总结
The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2.05mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiology (ASA) class 2 and 3
- •English speaking
- •Gestational age > 36 weeks
- •Scheduled for cesarean delivery under combined spinal epidural anesthesia
- •18 years or older
- •BMI > 50 kg/m2
排除标准
- •History of past or current intravenous drug or chronic opioid abuse
- •Allergy or contraindication to any study medications
- •Intrapartum cesarean delivery under epidural anesthesia
- •Cesarean delivery under general anesthesia
研究组 & 干预措施
Starting dose of Bupivacaine (9.75 mg)
The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9.75mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).
干预措施: Bupivacaine (Drug)
Subsequent dose
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Percent of successful blocks for operation (success operation)
时间窗: during surgery up to 90 minutes after intrathecal injection
successful initial sensory level without requiring additional epidural anesthetic
Percent of successful blocks for induction (success induction)
时间窗: 10 minutes after intrathecal drug administration
bilateral T6 sensory level to pinprick by
Number of Participants With Successful Blocks for Induction (Success Induction)
时间窗: 10 minutes after intrathecal drug administration
Bilateral T6 sensory level to pinprick
Number of Participants With Successful Blocks for Operation (Success Operation)
时间窗: during surgery up to 90 minutes after intrathecal injection
Successful initial sensory level without requiring additional epidural anesthetic
ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery
时间窗: 90 minutes
次要结局
未报告次要终点