Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
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- Are you between 18 and 65 years old?
Source: NCT07736352, who can take part
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- Who runs it
- China-Japan Friendship Hospital
- Trial code
- NCT07736352
- Record updated
- 28 October 2026
- Original description
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:Read full original descriptionShow less
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:
1. 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? 2. How these combination regimens affect the quality of recovery and postoperative pain in patients？
Participants will:
1. Receive one of four anesthesia regimens during surgery: propofol alone, propofol combined with midazolam, dexmedetomidine, or esketamine. 2. Undergo a stepwise reduction of propofol effect-site concentration towards the end of surgery. 3. Have their consciousness assessed using the isolated forearm technique, while BIS, EEG signals, and vital signs are continuously monitored throughout the procedure. 4. Have their recovery quality and postoperative pain assessed after surgery.
Inclusion: 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: History of neurological disorders; 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; Allergic to intravenous anesthetics; Hearing impairment, could not cooperate in intervention and evaluation; Cognitive dysfunction assessed by the Mini-Cog scale; Acute angle-closure glaucoma; Contraindications to tourniquet use on the upper arm.