Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
2026年7月26日 更新者：Ma Ye、China-Japan Friendship Hospital
A Prospective, Randomized Study to Determine the Appropriate Bispectral Index Range and Propofol Effect-Site Concentration During Total Intravenous Anesthesia Combined With Midazolam, Dexmedetomidine or Esketamine.
The goal of this clinical trial is to determine the appropriate Bispectral Index (BIS) range and propofol effect-site concentration required to maintain adequate anesthesia depth during total intravenous anesthesia (TIVA) combined with midazolam, dexmedetomidine, or esketamine in patients undergoing unilateral knee replacement surgery. The main questions it aims to answer are:
- What are the appropriate BIS range and propofol effect-site concentration for maintaining adequate anesthesia depth when combined with each of the three medications (midazolam, dexmedetomidine, or esketamine) during TIVA?
- How these combination regimens affect the quality of recovery and postoperative pain in patients？
Participants will:
- Receive one of four anesthesia regimens during surgery: propofol alone, propofol combined with midazolam, dexmedetomidine, or esketamine.
- Undergo a stepwise reduction of propofol effect-site concentration towards the end of surgery.
- Have their consciousness assessed using the isolated forearm technique, while BIS, EEG signals, and vital signs are continuously monitored throughout the procedure.
- Have their recovery quality and postoperative pain assessed after surgery.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
100
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
- 姓名：MA
- 电话号码：+86-10-84205882
- 邮箱：maye_1316@163.com
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:
- Age 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Body Mass Index (BMI) 18 to 30 kg/m²
- Scheduled for elective unilateral total knee replacement surgery
- Willing to participate in the study and signed informed consent form, and able to comply with the intervention and assessment procedures
Exclusion Criteria:
- History of neurological disorders
- Cognitive dysfunction assessed by the Mini-Cog scale
- History of antipsychotic or sedative medication use in the past 4 weeks
- Poorly controlled or untreated hypertension
- Sinus bradycardia, cardiac conduction block, or severe heart failure
- Acute angle-closure glaucoma
- Allergic to intravenous anesthetics
- Hearing impairment, could not cooperate in intervention and evaluation
- Contraindications to tourniquet use on the upper arm
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：预防
- 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 |
|---|---|
|
假比较器：Propofol + Remifentanil
|
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period.
After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated.
Participants will wear headphones playing recorded standardized instructions.
Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm.
The propofol plasma-site concentration will be reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
|
实验性的：Propofol + Remifentanil + Midazolam
|
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period.
After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated.
Participants will wear headphones playing recorded standardized instructions.
Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm.
Midazolam (2 mg) will be administered intravenously.The propofol plasma-site concentration will be set to 1.8 μg/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
|
实验性的：Propofol + Remifentanil + Dexmedetomidine
|
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period.
After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated.
Participants will wear headphones playing recorded standardized instructions.
Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm.
Dexmedetomidine 1 μg/kg infused over 10 minutes.The propofol plasma-site concentration will be set to 1.8 μg/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
|
实验性的：Propofol + Remifentanil + Esketamine
|
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period.
After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated.
Participants will wear headphones playing recorded standardized instructions.
Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm.
Esketamine (0.3 mg/kg) will be administered intravenously.The propofol plasma-site concentration will be set to 1.8 μg/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 75 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
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 |
|---|---|---|
|
BIS value
大体时间：From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.
|
BIS value recorded at the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia.
|
From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.
|
|
Propofol Effect-Site Concentration
大体时间：From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.
|
Propofol effect-site concentration recorded at the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia.
|
From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Modified Brice Questionnaire
大体时间：From PACU admission to 48 hours postoperatively. Assessed before PACU discharge, 24 hours and 48 hours postoperatively.
|
The presence of intra-operative awareness with recall is assessed using the Modified Brice Questionnaire.
The questionnaire explores the patient's memory of the peri-operative period through structured questions.
|
From PACU admission to 48 hours postoperatively. Assessed before PACU discharge, 24 hours and 48 hours postoperatively.
|
|
Time from Discontinuation of Anesthetics to Laryngeal Mask Airway Removal
大体时间：From discontinuation of anesthetics to LMA removal, assessed up to 60 minutes.
|
From discontinuation of anesthetics to LMA removal.
Successful removal is defined as the patient being awake, able to open mouth on command, and having return of protective reflexes, without signs of respiratory distress.
|
From discontinuation of anesthetics to LMA removal, assessed up to 60 minutes.
|
|
Time to Modified Aldrete Score of 10 in the Post Anesthesia Care Unit
大体时间：From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.
|
Time from post anesthesia care unit (PACU) admission until the first attainment of a Modified Aldrete Score of 10.
The Modified Aldrete Score assesses five domains: consciousness, activity, respiration, blood pressure, and oxygen saturation, each scored from 0 to 2, with a maximum total score of 10.
A score of 10 indicates the patient has achieved optimal recovery in all five domains.
|
From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.
|
|
Adverse Events During Emergence from Anesthesia
大体时间：From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.
|
Adverse events during the period from anesthetic discontinuation to PACU discharge are recorded.
|
From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.
|
|
Postoperative Pain Intensity Measured by Numeric Rating Scale
大体时间：From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.
|
Pain intensity is assessed using the Numeric Rating Scale, an 11-point scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst imaginable pain".
Patients are asked to rate their current pain intensity at each assessment time point.
The Numeric Rating Scale is a widely used and validated measure for postoperative pain assessment.
|
From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.
|
|
Analgesic Consumption
大体时间：From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.
|
Total amount of rescue analgesic medication administered to the patient from PACU admission to 48 hours postoperatively.
|
From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.
|
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。
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8月1日
初级完成 (估计的)
2027年1月31日
研究完成 (估计的)
2027年7月31日
研究注册日期
首次提交
2026年7月16日
首先提交符合 QC 标准的
2026年7月26日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月26日
最后验证
2026年7月1日
更多信息
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.