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Not yet recruiting NCT07736352

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

No phase Interventional Knee Osteoarthritis Replacement, Knee Elective Surgical Patients ASA Class I/II Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propofol + Remifentanil +Midazolam, Propofol + Remifentanil + Dexmedetomidine, Propofol + Remifentanil + Esketamine, Propofol + Remifentanil.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Replacement, Knee, Elective Surgical Patients, ASA Class I/II Patients. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Interventions

  • Drug Propofol + Remifentanil +Midazolam
    Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. Midazolam (2 mg) will be administered intravenously.The propofol plasma-site concentration will be set to 1.8 μg/mL, the
  • Drug Propofol + Remifentanil + Dexmedetomidine
    Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. Dexmedetomidine 1 μg/kg infused over 10 minutes.The propofol plasma-site concentration will be set to 1.8 μg/mL, then re
  • Drug Propofol + Remifentanil + Esketamine
    Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. Esketamine (0.3 mg/kg) will be administered intravenously.The propofol plasma-site concentration will be set to 1.8 μg/m
  • Drug Propofol + Remifentanil
    Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. The propofol plasma-site concentration will be reduced in stepwise decrements of 0.3 μg/mL, with each concentration main

Primary outcome measures

  • BIS value [Time frame: From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.]
  • Propofol Effect-Site Concentration [Time frame: From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.]
Secondary outcome measures (6)
  • Modified Brice Questionnaire [Time frame: From PACU admission to 48 hours postoperatively. Assessed before PACU discharge, 24 hours and 48 hours postoperatively.]
  • Time from Discontinuation of Anesthetics to Laryngeal Mask Airway Removal [Time frame: From discontinuation of anesthetics to LMA removal, assessed up to 60 minutes.]
  • Time to Modified Aldrete Score of 10 in the Post Anesthesia Care Unit [Time frame: From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.]
  • Adverse Events During Emergence from Anesthesia [Time frame: From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.]
  • Postoperative Pain Intensity Measured by Numeric Rating Scale [Time frame: From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.]
  • Analgesic Consumption [Time frame: From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07736352 · 2026-HX-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗