The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Midazolam, Dexmedetomidine, Esketamine, Propofol.
- Who it may be relevant to
- Registry conditions: Depth of Anesthesia Monitoring, BIS-EEG. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Midazolam
Midazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol. - Drug Dexmedetomidine
Dexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol. - Drug Esketamine
Esketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol. - Drug Propofol
Propofol will be administered as part of standardized total intravenous anesthesia in all study groups. - Drug Remifentanil
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
Primary outcome measures
- Change in Bispectral Index (BIS) value from the pre-intervention baseline [Time frame: Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration]
Secondary outcome measures (7)
- Change in mean arterial pressure from pre-intervention baseline [Time frame: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.]
- Change in heart rate from pre-intervention baseline [Time frame: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.]
- Time from discontinuation of anesthetic drugs to airway device removal [Time frame: 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 [Time frame: From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.]
- Brice questionnaire assessment [Time frame: Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.]
- Postoperative pain score [Time frame: 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 [Time frame: From admission to the post-anesthesia care unit to 48 hours after surgery.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT07699523 · 2026-HX-40