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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Región
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Santiago、Región、チリ、450881
- Hospital UC Christus
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ: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.
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実験的: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%.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total intraoperative opioid consumption
時間枠:Intraoperative period
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Mean fentanyl rate (mcg/kg).
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Intraoperative period
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sevoflurane exposure
時間枠:Intraoperative period
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Age-adjusted MAC-hours
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Intraoperative period
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Sevoflurane exposure
時間枠:Intraoperative period
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EtSevo
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Intraoperative period
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EEG burst suppression
時間枠:Intraoperative period
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incidence
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Intraoperative period
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EEG spectral markers_TBP
時間枠:Intraoperative period
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Total band power
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Intraoperative period
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EEG spectral markers_MedF
時間枠:Intraoperative period
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Median frequency
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Intraoperative period
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EEG spectral markers_SEF95
時間枠:Intraoperative period
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SEF 95%
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Intraoperative period
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EEG burst suppression
時間枠:Intraoperative period
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Cumulative duration
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Intraoperative period
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hemodynamic, Bradicardia
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Post anesthesia period
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incidence by paed scale
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Post anesthesia period
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Postoperative pain
時間枠:Post anesthesia period
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flacc/vas scores
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Post anesthesia period
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Rescue analgesia
時間枠: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
時間枠:Post anesthesia period
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fentanyl use for pain rescue (mcg)
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Post anesthesia period
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協力者と研究者
捜査官
- スタディチェア:Victor Contreras, MSN, RN、Researcher
- 主任研究者:Mauricio Ibacache, Phd、Professor
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 260319004
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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