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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 4 treatment groups

Locations

This trial has no locations