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

NCT07699523 · tracked via the Priya Life Science China tracker

Sponsor

China-Japan Friendship Hospital

Phase

Not applicable

Started

2026-07-14

Last updated

2026-10-28

Condition(s) studied

Depth of Anesthesia MonitoringBIS-EEG

Investigational drug(s) / intervention(s)

Midazolam →Dexmedetomidine →Esketamine →Propofol →Remifentanil →

Midazolam: Midazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.

Dexmedetomidine: Dexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.

Esketamine: Esketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.

Propofol: Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.

Remifentanil: Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. ASA physical status I-II; 2. BMI 18-28 kg/m²; 3. Scheduled for elective laparoscopic cholecystectomy, with an expected surgical duration from skin incision to completion of wound closure of ≥45 min; 4. Planned to receive propofol-remifentanil total intravenous anesthesia, with routine intraoperative BIS monitoring and simultaneous acquisition of raw EEG signals; 5. 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: 1. A confirmed history of psychiatric or neurological disorders, or use of antipsychotics, antidepressants, benzodiazepines, or other sedative-hypnotic drugs within 4 weeks before surgery; 2. Cognitive impairment identified by Mini-Cog screening; 3. Poorly controlled or untreated hypertension, sinus bradycardia, or severe cardiac conduction block; 4. Acute angle-closure glaucoma; 5. Known allergy to any required anesthetic drug; 6. Difficulty in electrode placement or any condition that may interfere with EEG monitoring.

Primary outcome measure(s)

Change in Bispectral Index (BIS) value from the pre-intervention baseline — Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration
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.

Trial sites (2)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
China-Japan Friendship Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07699523 on ClinicalTrials.gov ↗ ← All trials in China