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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- BIS value
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •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
排除标准
- •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
结局指标
主要结局
BIS value
时间窗: 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.
Propofol Effect-Site Concentration
时间窗: 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.
次要结局
- Modified Brice Questionnaire(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(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(From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.)
- Adverse Events During Emergence from Anesthesia(From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.)
- Postoperative Pain Intensity Measured by Numeric Rating Scale(From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.)
- Analgesic Consumption(From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.)
研究者
Ma Ye
Medical Doctor
China-Japan Friendship Hospital