BIS range and propofol depth during total IV anesthesia with adjuvants for knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to define the appropriate Bispectral Index (BIS) range and propofol effect-site concentration to maintain adequate anesthesia depth during total intravenous anesthesia (TIVA) when combined with either midazolam, dexmedetomidine, or esketamine in adults undergoing unilateral knee replacement. Participants are assigned to one of four regimens: propofol alone, or propofol with one of the three adjuvants, with a stepwise reduction of propofol near the end of surgery to assess recovery quality and postoperative pain. Outcomes focus on anesthesia depth control, recovery quality, and pain after surgery. The trial will be conducted at China-Japan Friendship Hospital in Beijing, with ASA I-II adults aged 18-65.

Why it matters

Who can join: the full rules

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

Where it's running

• China-Japan Friendship Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Ma
• Email: maye_1316@163.com
• Phone: +86-10-84205882

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.