Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The difference of 'wobble' value of the patients' BIS value between the two groups
研究概览
简要总结
Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern anesthesia. The purpose of this study is to compare two methods of administering desflurane, an volatile anesthetic during balanced anesthesia. The investigators hypothesized that administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth than administering desflurane according to the patient's BIS (bispectral index) value.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil
排除标准
- •Refusal of consent
- •General anesthesia with agents other than desflurane and remifentanil
- •Patients with allergy to neuromuscular blocker, volatile anesthetics, opioids
- •History of malignant hyperthermia
- •Patients taking CNS stimulants
- •Chronic alcohol abuser
- •Patients with severe depressed left ventricular function, EF < 30%
- •Patients with convulsive disorders
- •ASA class IV, V, VI
- •Patients with systolic arterial blood pressure lower than 90mmHg before surgery
- •Patients needing inotropic infusion during surgery
- •Anesthesia time less than 30 minutes
研究组 & 干预措施
Administering desflurane according to the patient's BIS value
The anesthesiologist administers the volatile anesthetic desflurane to set the patient's BIS value at 50 during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.
干预措施: Administering desflurane according to the patient's BIS value (Drug)
Administering desflurane at 1 MAC
The anesthesiologist administers the volatile anesthetic desflurane at 1 MAC during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.
干预措施: Administering desflurane at 1 MAC (Drug)
结局指标
主要结局
The difference of 'wobble' value of the patients' BIS value between the two groups
时间窗: Every second from 10 minutes after skin incision to 10 minutes before surgery end.
'Wobble' is a variable that can measure the performance measurement of a pharmacokinetic model, or the reaction of the patient to a drug. We can calculate the performance error from the target of the therapy and the actual measured value, and derive the wobble by a specific formulas, which are described below. PE=(BISmeasured-BIStargeted)x100/BIStargeted MDPEi = median{PEij, j=1,...,Ni} MDAPEi = median{\|PEij\|, j=1,...,Ni} Wobblei = median{\|PEij-MDPEi\|, j=1,...,Ni} Divergence = slope{\|PEij\|, j=1,...,Ni}
次要结局
- The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groups(Every 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery end)
研究者
Chul-Woo Jung
associate professor
Seoul National University Hospital