The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
2026년 7월 8일 업데이트: Li Zhao, China-Japan Friendship Hospital
This prospective, single-center, randomized interventional study aims to investigate the effects of commonly used adjunct anesthetic drugs on the Bispectral Index (BIS) and electroencephalographic (EEG) activity during total intravenous anesthesia.
BIS monitoring is widely used to estimate the depth of anesthesia. However, previous studies suggest that certain anesthetic drugs, particularly dexmedetomidine and esketamine, may alter BIS values independently of the patient's actual level of consciousness. As a result, BIS readings may not always accurately reflect anesthetic depth when multiple drugs are administered together.
Adult patients undergoing elective laparoscopic cholecystectomy under standardized propofol-remifentanil anesthesia will be randomly assigned to receive one of the following adjunct drugs: midazolam, dexmedetomidine, esketamine, or no additional study drug (control group). Continuous BIS values and raw EEG signals will be recorded throughout the study period.
The primary objective is to compare changes in BIS values among different adjunct anesthetic drugs under otherwise similar anesthetic conditions. The study will also explore corresponding EEG characteristics associated with these changes. The findings are expected to improve understanding of drug-related differences in processed EEG monitoring and provide data for future development of more accurate anesthesia depth assessment methods.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
120
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Li
- 전화번호: +86-15811578082
- 이메일: lizhao2001@aliyun.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- China-Japan Friendship Hospital
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연락하다:
- Li
- 전화번호: +86-15811578082
- 이메일: lizhao2001@aliyun.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
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아니
설명
Inclusion Criteria:
- ASA physical status I-II;
- BMI 18-28 kg/m²;
- Scheduled for elective laparoscopic cholecystectomy, with an expected surgical duration from skin incision to completion of wound closure of ≥45 min;
- Planned to receive propofol-remifentanil total intravenous anesthesia, with routine intraoperative BIS monitoring and simultaneous acquisition of raw EEG signals;
- Voluntarily agrees to participate in this study, has signed the informed consent form, and is able to cooperate with the intervention and assessment procedures.
Exclusion Criteria:
- A confirmed history of psychiatric or neurological disorders, or use of antipsychotics, antidepressants, benzodiazepines, or other sedative-hypnotic drugs within 4 weeks before surgery;
- Cognitive impairment identified by Mini-Cog screening;
- Poorly controlled or untreated hypertension, sinus bradycardia, or severe cardiac conduction block;
- Acute angle-closure glaucoma;
- Known allergy to any required anesthetic drug;
- Difficulty in electrode placement or any condition that may interfere with EEG monitoring.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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활성 비교기: Control Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia without administration of the study adjunct anesthetic drug.
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Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
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실험적: Midazolam Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol.
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Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
Midazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
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실험적: Dexmedetomidine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol.
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Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
Dexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
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실험적: Esketamine Group
Participants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol.
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Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
Esketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Bispectral Index (BIS) value from the pre-intervention baseline
기간: Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration
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Change in Bispectral Index value from the stable pre-intervention baseline will be compared among the four study groups after administration of the assigned adjunct anesthetic drug under standardized propofol-remifentanil total intravenous anesthesia.
The pre-intervention baseline is defined as the stable BIS value immediately before administration of the assigned adjunct anesthetic drug.
The Bispectral Index is a dimensionless electroencephalography-derived index ranging from 0 to 100, with lower values indicating deeper hypnotic states.
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Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in mean arterial pressure from pre-intervention baseline
기간: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Change in mean arterial pressure (MAP) from the stable pre-intervention baseline will be compared among the four study groups after administration of the assigned adjunct anesthetic drug under standardized propofol-remifentanil total intravenous anesthesia.
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Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Change in heart rate from pre-intervention baseline
기간: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Change in heart rate (HR) from the stable pre-intervention baseline will be compared among the four study groups after administration of the assigned adjunct anesthetic drug.
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Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Time from discontinuation of anesthetic drugs to airway device removal
기간: From discontinuation of anesthetic drugs to airway device removal, up to 60 minutes.
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The time interval from discontinuation of anesthetic drugs to removal of the airway device will be recorded.
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From discontinuation of anesthetic drugs to airway device removal, up to 60 minutes.
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Time to Aldrete score of 10 in the post-anesthesia care unit
기간: From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.
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The time from admission to the post-anesthesia care unit to achievement of an Aldrete score of 10 will be recorded.
The Aldrete score ranges from 0 to 10, with higher scores indicating better post-anesthesia recovery.
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From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.
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Brice questionnaire assessment
기간: Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
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The Brice questionnaire will be used to assess postoperative recall and awareness-related events.
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Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
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Postoperative pain score
기간: At admission to the post-anesthesia care unit, before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
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Postoperative pain intensity will be assessed using the numeric rating scale (NRS).
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At admission to the post-anesthesia care unit, before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
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Postoperative analgesic medication use
기간: From admission to the post-anesthesia care unit to 48 hours after surgery.
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Use of postoperative analgesic medications, including opioid and non-opioid analgesics (e.g., NSAIDs), in the post-anesthesia care unit and hospital ward will be recorded and compared among study groups.
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From admission to the post-anesthesia care unit to 48 hours after surgery.
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pre-specified electroencephalographic spectral features from baseline
기간: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Pre-specified electroencephalographic spectral features, including alpha-to-delta power ratio, frontal alpha power, alpha peak frequency, and burst suppression ratio, will be evaluated and compared among study groups at baseline and after administration of the assigned adjunct anesthetic drug.
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Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Change in electroencephalographic relative spectral power from baseline
기간: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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Relative power spectral density of delta, theta, alpha, beta, and gamma frequency bands will be compared among study groups at baseline and after administration of the assigned adjunct anesthetic drug.
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Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
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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)
연구 시작
2026년 6월 30일
기본 완료 (추정된)
기본 완료
2027년 6월 30일
연구 완료 (추정된)
연구 완료
2027년 12월 30일
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2026년 6월 26일
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2026년 7월 8일
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2026년 7월 13일
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QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
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2026년 7월 1일
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기타 연구 ID 번호
기타 연구 ID 번호
- 2026-HX-40
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