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The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Sponsor: China-Japan Friendship Hospital
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-06-30
Completion Date
2027-12-30
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China