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

RecruitingNAAges 18 Years - 65 YearsAllChina-Japan Friendship Hospital
NCT07736352 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Propofol + Remifentanil +Midazolam
  • Propofol + Remifentanil + Dexmedetomidine
  • Propofol + Remifentanil + Esketamine
  • Propofol + Remifentanil
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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