Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
2026년 7월 26일 업데이트: Ma Ye, China-Japan Friendship Hospital
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.
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:
- 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?
- How these combination regimens affect the quality of recovery and postoperative pain in patients？
Participants will:
- Receive one of four anesthesia regimens during surgery: propofol alone, propofol combined with midazolam, dexmedetomidine, or esketamine.
- Undergo a stepwise reduction of propofol effect-site concentration towards the end of surgery.
- Have their consciousness assessed using the isolated forearm technique, while BIS, EEG signals, and vital signs are continuously monitored throughout the procedure.
- Have their recovery quality and postoperative pain assessed after surgery.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: MA
- 전화번호: +86-10-84205882
- 이메일: maye_1316@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
가짜 비교기: 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 maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
|
실험적: 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, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
|
실험적: 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 reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
|
실험적: 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/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS > 75 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
BIS value
기간: 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.
|
BIS value recorded at the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia.
|
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
기간: 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 recorded at the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia.
|
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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Modified Brice Questionnaire
기간: From PACU admission to 48 hours postoperatively. Assessed before PACU discharge, 24 hours and 48 hours postoperatively.
|
The presence of intra-operative awareness with recall is assessed using the Modified Brice Questionnaire.
The questionnaire explores the patient's memory of the peri-operative period through structured questions.
|
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
기간: From discontinuation of anesthetics to LMA removal, assessed up to 60 minutes.
|
From discontinuation of anesthetics to LMA removal.
Successful removal is defined as the patient being awake, able to open mouth on command, and having return of protective reflexes, without signs of respiratory distress.
|
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
기간: From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.
|
Time from post anesthesia care unit (PACU) admission until the first attainment of a Modified Aldrete Score of 10.
The Modified Aldrete Score assesses five domains: consciousness, activity, respiration, blood pressure, and oxygen saturation, each scored from 0 to 2, with a maximum total score of 10.
A score of 10 indicates the patient has achieved optimal recovery in all five domains.
|
From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.
|
|
Adverse Events During Emergence from Anesthesia
기간: From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.
|
Adverse events during the period from anesthetic discontinuation to PACU discharge are recorded.
|
From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.
|
|
Postoperative Pain Intensity Measured by Numeric Rating Scale
기간: From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.
|
Pain intensity is assessed using the Numeric Rating Scale, an 11-point scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst imaginable pain".
Patients are asked to rate their current pain intensity at each assessment time point.
The Numeric Rating Scale is a widely used and validated measure for postoperative pain assessment.
|
From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.
|
|
Analgesic Consumption
기간: From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.
|
Total amount of rescue analgesic medication administered to the patient from PACU admission to 48 hours postoperatively.
|
From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.
|
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 1월 31일
연구 완료 (추정된)
2027년 7월 31일
연구 등록 날짜
최초 제출
2026년 7월 16일
QC 기준을 충족하는 최초 제출
2026년 7월 26일
처음 게시됨 (실제)
2026년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 26일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-HX-39
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