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Can brain monitoring during anesthesia prevent surgery awareness?

NCT ID NCT07389798

Knowledge-focused Sponsor: Tongji Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study reviewed records of 511 adults who had short ear, nose, or throat surgeries under a specific type of anesthesia (remimazolam plus flumazenil). Researchers wanted to see if keeping the brain's activity level (measured by BIS) below 60 during surgery affected the chance of patients being aware. The goal is to find the best anesthesia depth to improve safety and comfort.

What this could mean

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

Active substance
remimazolam and flumazenil
What this could lead to
If successful, this could help doctors choose the best anesthesia depth to reduce the risk of patients being aware during surgery.
What could go wrong
This is a retrospective review, not a controlled trial, so it can't prove cause and effect. Results may not apply to other types of surgery or anesthesia.

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.

Participants

511 people

The number who actually took part.

Started

Mar 2026

Finished

Apr 2026

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.

Who is studied

Patients who underwent short-duration surgeries with remimazolam TIVA combined with flumazenil antagonism in the Department of Otorhinolaryngology at Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology, from January 1, 2024, to December 31, 2025, were included.

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: * Age 18-65 years * ASA I-III * Underwent short-duration ENT surgery * Underwent remimazolam TIVA combined with flumazenil antagonism. * Continuous intraoperative BIS monitoring Exclusion Criteria: * Comorbid severe underlying diseases * Intraoperative BIS data were missing or incompletely recorded * Severe lack of medical records

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As listed by the trial registrant

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

Bispectral index Remimazolam Total intravenous anesthesia

Contacts and locations

Locations

  • Tongji Hospital

    Wuhan, Hubei, 430030, China

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