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The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia

2026年7月8日 更新者：Li Zhao、China-Japan Friendship Hospital

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100029
        • China-Japan Friendship Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. ASA physical status I-II;
  2. BMI 18-28 kg/m²;
  3. Scheduled for elective laparoscopic cholecystectomy, with an expected surgical duration from skin incision to completion of wound closure of ≥45 min;
  4. Planned to receive propofol-remifentanil total intravenous anesthesia, with routine intraoperative BIS monitoring and simultaneous acquisition of raw EEG signals;
  5. Voluntarily agrees to participate in this study, has signed the informed consent form, and is able to cooperate with the intervention and assessment procedures.

Exclusion Criteria:

  1. A confirmed history of psychiatric or neurological disorders, or use of antipsychotics, antidepressants, benzodiazepines, or other sedative-hypnotic drugs within 4 weeks before surgery;
  2. Cognitive impairment identified by Mini-Cog screening;
  3. Poorly controlled or untreated hypertension, sinus bradycardia, or severe cardiac conduction block;
  4. Acute angle-closure glaucoma;
  5. Known allergy to any required anesthetic drug;
  6. Difficulty in electrode placement or any condition that may interfere with EEG monitoring.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia without administration of the study adjunct anesthetic drug.
药品：Propofol
Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Remifentanil
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
实验性的：Midazolam Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol.
药品：Propofol
Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Remifentanil
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Midazolam
Midazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
实验性的：Dexmedetomidine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol.
药品：Propofol
Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Remifentanil
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Dexmedetomidine
Dexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
实验性的：Esketamine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol.
药品：Propofol
Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Remifentanil
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
药品：Esketamine
Esketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Bispectral Index (BIS) value from the pre-intervention baseline
大体时间：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.
Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration

次要结果测量

结果测量
措施说明
大体时间
Change in mean arterial pressure from pre-intervention baseline
大体时间：Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Change in mean arterial pressure (MAP) 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.
Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Change in heart rate from pre-intervention baseline
大体时间：Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Change in heart rate (HR) from the stable pre-intervention baseline will be compared among the four study groups after administration of the assigned adjunct anesthetic drug.
Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Time from discontinuation of anesthetic drugs to airway device removal
大体时间：From discontinuation of anesthetic drugs to airway device removal, up to 60 minutes.
The time interval from discontinuation of anesthetic drugs to removal of the airway device will be recorded.
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
大体时间：From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.
The time from admission to the post-anesthesia care unit to achievement of an Aldrete score of 10 will be recorded. The Aldrete score ranges from 0 to 10, with higher scores indicating better post-anesthesia recovery.
From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.
Brice questionnaire assessment
大体时间：Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
The Brice questionnaire will be used to assess postoperative recall and awareness-related events.
Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
Postoperative pain score
大体时间：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 pain intensity will be assessed using the numeric rating scale (NRS).
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
大体时间：From admission to the post-anesthesia care unit to 48 hours after surgery.
Use of postoperative analgesic medications, including opioid and non-opioid analgesics (e.g., NSAIDs), in the post-anesthesia care unit and hospital ward will be recorded and compared among study groups.
From admission to the post-anesthesia care unit to 48 hours after surgery.

其他结果措施

结果测量
措施说明
大体时间
Change in pre-specified electroencephalographic spectral features from baseline
大体时间：Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Pre-specified electroencephalographic spectral features, including alpha-to-delta power ratio, frontal alpha power, alpha peak frequency, and burst suppression ratio, will be evaluated and compared among study groups at baseline and after administration of the assigned adjunct anesthetic drug.
Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Change in electroencephalographic relative spectral power from baseline
大体时间：Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Relative power spectral density of delta, theta, alpha, beta, and gamma frequency bands will be compared among study groups at baseline and after administration of the assigned adjunct anesthetic drug.
Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China-Japan Friendship Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月30日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-HX-40

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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