The Effect of Chronic Opioid Use on Minimum Alveolar Concentration of Sevoflurane for Maintaining Bispectral(BIS) Index Below 50 ; Prospective, Blind Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%)
研究概览
简要总结
The purpose of this study is to find difference in Minimum Alveolar Concentration(MAC) for maintaining Bispectral Index (BIS) below 50 between chronic opioid users and opioid naive patients.
详细描述
- Patients selection in elective surgery which need general anesthesia.
- MAC BIS50 data was collected in each patients (by blinded investigator)
- The data collection will be continued for enough sample size for using Dixon Up Down Method Analysis
- After Data collection, MAC BIS below 50 will be analyzed in both groups ( Chronic opioid users versus opioid naive patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients(ASA class I-III) who receive elective surgery
- •signed in informed consent to participate in this trial voluntarily.
排除标准
- •History of Monoamine Oxidase (MAO) inhibitor use
- •Chronic alcoholics
- •Acute alcohol abuser
- •Contraindication for inhalation agent use (Sevoflurane)
- •History of medication use, which affect in the minimum concentration of sevoflurane;(barbiturates, chlorpromazine, diazepam, hydroxyzine, verapamil, marijuana)
- •Craniotomy
研究组 & 干预措施
Chronic Opioid User
The patients (ASA class I-III) who receive elective surgery s aging between 41 and 69 and signed in informed consent to participate in this trial voluntarily.
The Patients who use opioid medication daily and regularly immediately before the day of surgery for more than four weeks. The minimum criteria for opioid dose in the intervention goup is oral morphine 20mg per day: Morphine Equivalent Daily Dose(MEDD)
干预措施: History for opioid use (Other)
Opioid Naive patient
The patients (ASA class I-III) who receive elective surgery aging between 41 and 69 and signed in informed consent to participate in this trial voluntarily.
The patients who do not use opioid medications immediately before the day of surgery for four weeks.
结局指标
主要结局
Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%)
时间窗: 15 minutes after pre-set of the concentration of sevoflurane
Dixon's up down method is applied in this study. So pre-set concentration of sevoflurane will be used in each group.
次要结局
未报告次要终点
研究者
Oh Tak Kyu
Anesthesiologist
National Cancer Center, Korea