Comparison of Quantitative EEG Parameters During Anesthesia Emergence Between Remimazolam Group and Propofol Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- frontal spectral power
研究概览
简要总结
This is an observational study comparing perioperative quantitative EEG parameters between the conventional propofol/remifentanil and remimazolam/remifentanil. We aim to compare and analyze the differences in EEG patterns during the postoperative recovery in a group that underwent remimazolam and remifentanil-based total intravenous anesthesia(TIVA), in comparison to propofol and remifentanil-based TIVA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The principal investigator and the anesthesiologist directly involved in anesthetizing the respective patients should be aware of patient allocation due to the nature of research design and anesthesia maintenance. Two research personnel, who are unaware of the type of test drug (blinding), are not involved in anesthesia but are responsible only for data collection and analysis.
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 to 65 years who meet the American Society of Anesthesiologists (ASA) physical status classification 1-3 and undergo laparoscopic cholecystectomy at Severance Hospital.
排除标准
- •Pregnant women, individuals with arrhythmias, emergency surgeries, obesity (BMI > 30), day-surgery, foreigners, and illiterate individuals.
研究组 & 干预措施
propofol group
During induction, the propofol group initiates with a target-controlled infusion (TCI) of propofol, starting at an effect site concentration of 4.0 ng/ml. After intubation, it is adjusted to maintain an appropriate depth of anesthesia based on the EEG (psi target 40).
干预措施: propofol group (Drug)
remimazolam group
The remimazolam group begins with a continuous infusion of remimazolam at 6 mg/kg/hr, which is then adjusted to 1 mg/kg/hr after loss of consciousness to maintain an appropriate depth of anesthesia based on the EEG (psi target 40).
干预措施: remimazolam group (Drug)
结局指标
主要结局
frontal spectral power
时间窗: immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU)
Frontal spectral power in EEG (Electroencephalography) refers to the measurement of electrical activity in the frontal lobes of the brain across different frequency bands. Frontal spectral power specifically focuses on the electrical activity in the frontal region of the brain within these frequency bands. Different frequency bands are associated with different states of brain activity. For example, alpha waves are often associated with relaxation or idling of the brain, while beta waves are linked to more active cognitive processing.
次要结局
- Riker sedation-agitation score(immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU))