The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Bispectral Index (BIS) value from the pre-intervention baseline
研究概览
简要总结
This prospective, single-center, randomized interventional study aims to investigate the effects of commonly used adjunct anesthetic drugs on the Bispectral Index (BIS) and electroencephalographic (EEG) activity during total intravenous anesthesia.
BIS monitoring is widely used to estimate the depth of anesthesia. However, previous studies suggest that certain anesthetic drugs, particularly dexmedetomidine and esketamine, may alter BIS values independently of the patient's actual level of consciousness. As a result, BIS readings may not always accurately reflect anesthetic depth when multiple drugs are administered together.
Adult patients undergoing elective laparoscopic cholecystectomy under standardized propofol-remifentanil anesthesia will be randomly assigned to receive one of the following adjunct drugs: midazolam, dexmedetomidine, esketamine, or no additional study drug (control group). Continuous BIS values and raw EEG signals will be recorded throughout the study period.
The primary objective is to compare changes in BIS values among different adjunct anesthetic drugs under otherwise similar anesthetic conditions. The study will also explore corresponding EEG characteristics associated with these changes. The findings are expected to improve understanding of drug-related differences in processed EEG monitoring and provide data for future development of more accurate anesthesia depth assessment methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II;
- •BMI 18-28 kg/m²;
- •Scheduled for elective laparoscopic cholecystectomy, with an expected surgical duration from skin incision to completion of wound closure of ≥45 min;
- •Planned to receive propofol-remifentanil total intravenous anesthesia, with routine intraoperative BIS monitoring and simultaneous acquisition of raw EEG signals;
- •Voluntarily agrees to participate in this study, has signed the informed consent form, and is able to cooperate with the intervention and assessment procedures.
排除标准
- •A confirmed history of psychiatric or neurological disorders, or use of antipsychotics, antidepressants, benzodiazepines, or other sedative-hypnotic drugs within 4 weeks before surgery;
- •Cognitive impairment identified by Mini-Cog screening;
- •Poorly controlled or untreated hypertension, sinus bradycardia, or severe cardiac conduction block;
- •Acute angle-closure glaucoma;
- •Known allergy to any required anesthetic drug;
- •Difficulty in electrode placement or any condition that may interfere with EEG monitoring.
研究组 & 干预措施
Control Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia without administration of the study adjunct anesthetic drug.
干预措施: Propofol (Drug)
Control Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia without administration of the study adjunct anesthetic drug.
干预措施: Remifentanil (Drug)
Midazolam Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol.
干预措施: Midazolam (Drug)
Midazolam Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol.
干预措施: Propofol (Drug)
Midazolam Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol.
干预措施: Remifentanil (Drug)
Dexmedetomidine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol.
干预措施: Propofol (Drug)
Dexmedetomidine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol.
干预措施: Remifentanil (Drug)
Esketamine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol.
干预措施: Esketamine (Drug)
Esketamine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol.
干预措施: Propofol (Drug)
Esketamine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Change in Bispectral Index (BIS) value from the pre-intervention baseline
时间窗: Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration
Change in Bispectral Index value from the stable pre-intervention baseline will be compared among the four study groups after administration of the assigned adjunct anesthetic drug under standardized propofol-remifentanil total intravenous anesthesia. The pre-intervention baseline is defined as the stable BIS value immediately before administration of the assigned adjunct anesthetic drug. The Bispectral Index is a dimensionless electroencephalography-derived index ranging from 0 to 100, with lower values indicating deeper hypnotic states.
次要结局
- Change in mean arterial pressure from pre-intervention baseline(Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.)
- Change in heart rate from pre-intervention baseline(Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.)
- Time from discontinuation of anesthetic drugs to airway device removal(From discontinuation of anesthetic drugs to airway device removal, up to 60 minutes.)
- Time to Aldrete score of 10 in the post-anesthesia care unit(From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.)
- Brice questionnaire assessment(Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.)
- Postoperative pain score(At admission to the post-anesthesia care unit, before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.)
- Postoperative analgesic medication use(From admission to the post-anesthesia care unit to 48 hours after surgery.)
研究者
Li Zhao
Principal Investigator
China-Japan Friendship Hospital