Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.

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Conditions studied: Knee Osteoarthritis, Replacement, Knee, Elective Surgical Patients, ASA Class I/II Patients

In brief

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.

Key facts

Study ID: NCT07736352
Run by: China-Japan Friendship Hospital
People needed: 100
Starts: 2026-08-01
Expected to finish: 2027-07-31
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Full record on ClinicalTrials.gov

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