The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
2026年7月8日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Li
- 電話番号：+86-15811578082
- メール：lizhao2001@aliyun.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100029
- China-Japan Friendship Hospital
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コンタクト：
- Li
- 電話番号：+86-15811578082
- メール：lizhao2001@aliyun.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
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
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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実験的：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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実験的：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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実験的：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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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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Change in Bispectral Index (BIS) value from the pre-intervention baseline
時間枠：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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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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Change in mean arterial pressure from pre-intervention baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pre-specified electroencephalographic spectral features from baseline
時間枠：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
時間枠：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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ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月30日
一次修了 (推定)
2027年6月30日
研究の完了 (推定)
2027年12月30日
試験登録日
最初に提出
2026年6月26日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-HX-40
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