- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07714785
Impact of EEG-guided Sevofluorane on Opioid Consumption and Quality of Awakening
Impact of EEG-guided Sevoflurane Titration on Opioid Consumption and Emergency Quality in Pediatric Patients Undergoing Surgery Without Regional Anesthesia
연구 개요
상세 설명
Electroencephalography (EEG)-guided anesthetic titration has demonstrated significant clinical benefits in both pediatric and adult patients. However, proprietary EEG-based indices widely used for monitoring anesthetic depth are affected by patient age and the specific anesthetic agent used, limiting their validity and generalizability. More recently, titrating anesthetics based on a specific interpretation of EEG waveforms and their oscillatory patterns observed on the spectrogram has gained popularity.
Previous studies indicate that sevoflurane titration based on specific EEG waveforms and oscillatory patterns yields more substantial reductions in sevoflurane exposure than previously reported with proprietary EEG indices. Furthermore, reducing sevoflurane exposure decreases the incidence of EEG burst suppression, results in faster emergence times, and reduces emergence delirium.
However, most of these benefits have been reported in the context of surgeries where intraoperative antinociception was provided via central or peripheral nerve blocks, in the absence of increased intraoperative analgesic and opioid requirements. It remains unclear whether the benefits associated with reduced sevoflurane exposure are also observed in surgeries where intraoperative antinociception cannot be provided through regional blocks. In such cases, antinociception depends primarily on the co-administration of inhaled anesthetics and opioids. Therefore, the clinical benefits of decreasing sevoflurane exposure via electroencephalographic guidance must be weighed against the side effects of higher perioperative opioid requirements.
What will be the impact of strict titration of the hypnotic component using electroencephalography in a painful surgery, in terms of intraoperative opioid consumption and the quality of anesthetic emergence? It is hypothesized that to adjust the sevoflurane dose according to EEG targets in children undergoing surgeries where intraoperative antinociception cannot be provided via regional blocks will result in a reduction of sevoflurane requirements. However, a compensatory increase in intraoperative opioid consumption is expected to be observed, which could subsequently affect the quality and duration of the anesthetic recovery period.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Región
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Santiago, Región, 칠레, 450881
- Hospital UC Christus
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 2-8 years
- ASA Physical Status I or II
- Elective tonsillectomy (±adenoidectomy)
- Signed parental consent (and assent ≥7 years)
Exclusion Criteria:
- Neurological or psychiatric disorders
- Growth or developmental delay
- Known allergy to study medications
- Coagulation disorders
- Parental or patient refusal
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Control Group
Induction with sevoflurane 5% in O₂.
Maintenance at fixed 1 age-adjusted MAC in O₂/air FiO₂ 60%.
BIS monitor attached but screen concealed; anesthesiologist blinded to EEG data.
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Arm Description: Induction with sevoflurane 5% in O₂.
Maintenance at fixed 1 age-adjusted MAC in O₂/air FiO₂ 60%.
BIS monitor attached but screen concealed; anesthesiologist blinded to EEG data.
|
|
실험적: Intervention Group
Induction with sevoflurane 3% in O₂.
Maintenance titrated to the minimum concentration sustaining a continuous slow-delta/alpha EEG pattern (SEF 17-20 Hz), starting at 0.7 age-adjusted MAC in O₂/air FiO₂ 60%.
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Induction with sevoflurane 3% in O₂.
Maintenance titrated to the minimum concentration sustaining a continuous slow-delta/alpha EEG pattern (SEF 17-20 Hz), starting at 0.7 age-adjusted MAC in O₂/air FiO₂ 60%.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total intraoperative opioid consumption
기간: Intraoperative period
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Mean fentanyl rate (mcg/kg).
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Intraoperative period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sevoflurane exposure
기간: Intraoperative period
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Age-adjusted MAC-hours
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Intraoperative period
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Sevoflurane exposure
기간: Intraoperative period
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EtSevo
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Intraoperative period
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EEG burst suppression
기간: Intraoperative period
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incidence
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Intraoperative period
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EEG spectral markers_TBP
기간: Intraoperative period
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Total band power
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Intraoperative period
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EEG spectral markers_MedF
기간: Intraoperative period
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Median frequency
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Intraoperative period
|
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EEG spectral markers_SEF95
기간: Intraoperative period
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SEF 95%
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Intraoperative period
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EEG burst suppression
기간: Intraoperative period
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Cumulative duration
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Intraoperative period
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hemodynamic, Bradicardia
기간: Intraoperative period
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Intraoperative bradycardia (HR<20% basaline) requiring intervention
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Intraoperative period
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hemodynamic, hypotension
기간: Intraoperative period
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intraoperative hypotension (MAP<20% basaline) requiring intervention
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Intraoperative period
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emergence time
기간: From end of anesthesia period to extubation
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Time from anesthesia discontinuation to extubation
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From end of anesthesia period to extubation
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Eye opening, emergence time
기간: From end of anesthesia period to extubation
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Time from anesthesia discontinuation to eye opening
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From end of anesthesia period to extubation
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emergence delirium
기간: Post anesthesia period
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incidence by paed scale
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Post anesthesia period
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Postoperative pain
기간: Post anesthesia period
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flacc/vas scores
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Post anesthesia period
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Rescue analgesia
기간: Post anesthesia period
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Drug use for rescue analgesia non opioids (mg)
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Post anesthesia period
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postoperative opioid use
기간: Post anesthesia period
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fentanyl use for pain rescue (mcg)
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Post anesthesia period
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공동 작업자 및 조사자
수사관
- 연구 의자: Victor Contreras, MSN, RN, Researcher
- 수석 연구원: Mauricio Ibacache, Phd, Professor
간행물 및 유용한 링크
일반 간행물
- Wang HY, Chen TY, Li DJ, Lin PY, Su KP, Chiang MH, Carvalho AF, Stubbs B, Tu YK, Wu YC, Roerecke M, Smith L, Tseng PT, Hung KC. Association of pharmacological prophylaxis with the risk of pediatric emergence delirium after sevoflurane anesthesia: An updated network meta-analysis. J Clin Anesth. 2021 Dec;75:110488. doi: 10.1016/j.jclinane.2021.110488. Epub 2021 Sep 1.
- Miyasaka KW, Suzuki Y, Brown EN, Nagasaka Y. EEG-Guided Titration of Sevoflurane and Pediatric Anesthesia Emergence Delirium: A Randomized Clinical Trial. JAMA Pediatr. 2025 Apr 21;179(7):704-12. doi: 10.1001/jamapediatrics.2025.0517. Online ahead of print.
- Sun Y, Ye F, Wang J, Ai P, Wei C, Wu A, Xie W. Electroencephalography-Guided Anesthetic Delivery for Preventing Postoperative Delirium in Adults: An Updated Meta-analysis. Anesth Analg. 2020 Sep;131(3):712-719. doi: 10.1213/ANE.0000000000004746.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 260319004
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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