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

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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
• Препарат 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
• Препарат 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

Первичные конечные точки

• BIS value [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (6)

• Modified Brice Questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.]
• Adverse Events During Emergence from Anesthesia [Срок оценки: From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.]
• Postoperative Pain Intensity Measured by Numeric Rating Scale [Срок оценки: From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.]
• Analgesic Consumption [Срок оценки: From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07736352 · 2026-HX-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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