The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia

Обзор

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.

Вмешательства

• Препарат Midazolam
  Midazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
• Препарат Dexmedetomidine
  Dexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
• Препарат Esketamine
  Esketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
• Препарат Propofol
  Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
• Препарат Remifentanil
  Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.

Первичные конечные точки

• Change in Bispectral Index (BIS) value from the pre-intervention baseline [Срок оценки: Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration]

Вторичные конечные точки (7)

• Change in mean arterial pressure from pre-intervention baseline [Срок оценки: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.]
• Change in heart rate from pre-intervention baseline [Срок оценки: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.]
• Time from discontinuation of anesthetic drugs to airway device removal [Срок оценки: From discontinuation of anesthetic drugs to airway device removal, up to 60 minutes.]
• Time to Aldrete score of 10 in the post-anesthesia care unit [Срок оценки: From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.]
• Brice questionnaire assessment [Срок оценки: Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.]
• Postoperative pain score [Срок оценки: At admission to the post-anesthesia care unit, before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.]
• Postoperative analgesic medication use [Срок оценки: From admission to the post-anesthesia care unit to 48 hours after surgery.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07699523 · 2026-HX-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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