Depth of Anesthesia MonitoringNCT07699523
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
A study testing Midazolam, Dexmedetomidine and Esketamine in people with Depth of Anesthesia Monitoring and BIS-EEG, run by China-Japan Friendship Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depth of Anesthesia Monitoring, BIS-EEG
- What is being tested?
- Midazolam, Dexmedetomidine and Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Li, +86-15811578082, lizhao2001@aliyun.com
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhao Li, +86 15811578082, lizhao2001@aliyun.com
About this study
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.
Read more
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.
- Conditions
- Depth of Anesthesia Monitoring, BIS-EEG
- Being tested
- Midazolam, Dexmedetomidine, Esketamine, Propofol, Remifentanil
- Keywords
- Bispectral Index, Electroencephalography, Midazolam, Dexmedetomidine, Esketamine, Total Intravenous Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
DexmedetomidineDrug
Dexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
EsketamineDrug
Esketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol.
PropofolDrug
Propofol will be administered as part of standardized total intravenous anesthesia in all study groups.
RemifentanilDrug
Remifentanil will be administered as part of standardized total intravenous anesthesia in all study groups.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants receive standardized propofol-remifentanil total intravenous anesthesia without administration of the study adjunct anesthetic drug. Receives: Drug: Propofol; Drug: Remifentanil |
| Midazolam Group | Experimental | Participants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol. Receives: Drug: Midazolam; Drug: Propofol; Drug: Remifentanil |
| Dexmedetomidine Group | Experimental | Participants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol. Receives: Drug: Dexmedetomidine; Drug: Propofol; Drug: Remifentanil |
| Esketamine Group | Experimental | Participants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol. Receives: Drug: Esketamine; Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bispectral Index (BIS) value from the pre-intervention baseline
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.
Measured: Baseline and 5, 10, 15, 20, 25, 30 minutes after adjunct drug administration
Secondary outcomes (7)
Change in mean arterial pressure from pre-intervention baseline
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.
Measured: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Change in heart rate from pre-intervention baseline
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.
Measured: Baseline and 5, 10, 15, 20, 25, and 30 minutes after adjunct drug administration.
Time from discontinuation of anesthetic drugs to airway device removal
The time interval from discontinuation of anesthetic drugs to removal of the airway device will be recorded.
Measured: 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
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.
Measured: From admission to the post-anesthesia care unit to achievement of an Aldrete score of 10, up to 2 hours.
Brice questionnaire assessment
The Brice questionnaire will be used to assess postoperative recall and awareness-related events.
Measured: Before discharge from the post-anesthesia care unit, and at 24 and 48 hours after surgery.
Postoperative pain score
Postoperative pain intensity will be assessed using the numeric rating scale (NRS).
Measured: 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
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.
Measured: From admission to the post-anesthesia care unit to 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start14 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth of Anesthesia MonitoringStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699523
- Sponsor's protocol ID
- 2026-HX-40
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
- ClinicalTrials.gov ID
- NCT07699523
- Acronym / sponsor ID
- 2026-HX-40
- Conditions
- Depth of Anesthesia Monitoring, BIS-EEG
- Keywords
- Bispectral Index, Electroencephalography, Midazolam, Dexmedetomidine, Esketamine, Total Intravenous Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Propofol, Drug: RemifentanilParticipants receive standardized propofol-remifentanil total intravenous anesthesia without administration of the study adjunct anesthetic drug. |
| Midazolam Group | Experimental | Drug: Midazolam, Drug: Propofol, Drug: RemifentanilParticipants receive standardized propofol-remifentanil total intravenous anesthesia plus midazolam according to the study protocol. |
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine, Drug: Propofol, Drug: RemifentanilParticipants receive standardized propofol-remifentanil total intravenous anesthesia plus dexmedetomidine according to the study protocol. |
| Esketamine Group | Experimental | Drug: Esketamine, Drug: Propofol, Drug: RemifentanilParticipants receive standardized propofol-remifentanil total intravenous anesthesia plus esketamine according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamMidazolam administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol. | Drug | Midazolam Group |
| DexmedetomidineDexmedetomidine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol. | Drug | Dexmedetomidine Group |
| EsketamineEsketamine administered as an adjunct to standardized propofol-remifentanil total intravenous anesthesia according to the study protocol. | Drug | Esketamine Group |
| PropofolPropofol will be administered as part of standardized total intravenous anesthesia in all study groups. | Drug | Control Group, Dexmedetomidine Group, Esketamine Group, Midazolam Group |
| RemifentanilRemifentanil will be administered as part of standardized total intravenous anesthesia in all study groups. | Drug | Control Group, Dexmedetomidine Group, Esketamine Group, Midazolam Group |
Primary outcome
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
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, Dexmedetomidine and Esketamine in people with Depth of Anesthesia Monitoring and BIS-EEG, run by China-Japan Friendship Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li (+86-15811578082, lizhao2001@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.