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Brain monitor accuracy under scrutiny: anesthesia cocktail may skew readings

NCT ID NCT07699523

Knowledge-focused Sponsor: China-Japan Friendship Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (paused)
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Expanded access (ended)
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Approved
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When the status isn't known

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Status unknown
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First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study investigates how three common anesthetic drugs—midazolam, dexmedetomidine, and esketamine—affect the Bispectral Index (BIS), a brain monitor used to gauge depth of anesthesia. Researchers will enroll 120 adults undergoing gallbladder surgery under a standard propofol-remifentanil anesthetic. By comparing BIS and raw EEG changes among the drug groups, the study aims to clarify when BIS readings may misrepresent a patient's true level of consciousness, potentially improving anesthesia safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Midazolam, Dexmedetomidine, Esketamine
What this could lead to
If successful, this could help anesthesiologists better interpret brain activity monitors when multiple drugs are used, potentially reducing the risk of awareness during surgery.
What could go wrong
This is a small, early-phase study focused on monitoring changes, not on patient outcomes. Results may not apply to other surgeries or anesthesia combinations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bis-eeg Depth of anesthesia monitoring

How to take part

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  2. The official record

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Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

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