RemimazolamTIVANCT07389798
Remimazolam TIVA-Flumazenil Antagonism in Short-duration ENT Surgeries
An observational study of Remimazolam and Total Intravenous Anesthesia, run by Tongji Hospital at 1 site in China.
Trial summary
This study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism based on whether their intraoperative BIS values were maintained below 60. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Remimazolam, Total Intravenous Anesthesia, Bispectral Index
- How many people
- 511 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 4 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 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.
Who may be able to join
- Age 18-65 years
- ASA I-III
- Underwent short-duration ENT surgery
- Underwent remimazolam TIVA combined with flumazenil antagonism.
- Continuous intraoperative BIS monitoring
Who cannot join
- Comorbid severe underlying diseases
- Intraoperative BIS data were missing or incompletely recorded
- Severe lack of medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Bispectral Index Guided Remimazolam Total Intravenous Anesthesia-flumazenil Antagonism in Short-duration Ear Nose Throat Surgeries: A Retrospective Cohort Study
This study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism based on whether their intraoperative BIS values were maintained below 60.
Read the detailed description
This study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism into two groups based on whether their intraoperative BIS values were maintained below 60. It aims to compare the differences in postoperative recovery quality between the groups, thereby providing evidence-based support for determining the optimal BIS target range during remimazolam TIVA.
- Conditions
- Remimazolam, Total Intravenous Anesthesia, Bispectral Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AB group | Intraoperative BIS values ≤60 | |
| HB group | Intraoperative BIS values >60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative awareness
Modified Brice Interview From the start of surgery to the end of surgery
Measured: 2hours
Secondary outcomes (7)
Incidence of secondary sedation
Incidence of secondary sedation from flumazenil antagonization to discharge from the PACU
Measured: 1 day
mean arterial pressure
The fluctuation range of intraoperative mean arterial pressure during surgery
Measured: 2 hours
heart rate
The fluctuation range of intraoperative heart rate during surgery
Measured: 2 hours
usage of vasoactive drugs
Intraoperative use of vasoactive drugs during surgery
Measured: 2 hours
Drug doses
Drug doses during surgery
Measured: 2 hours
Awakening time
From the end of anesthesia to awakening.
Measured: 1 hours
PACU stay
From admission to the PACU to discharge from the PACU.
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Mar 2026
- Primary completion29 Mar 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Aihua Du, Dr, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389798
- Sponsor's protocol ID
- RTFA
- Acronym
- TIVA
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Individual data sharing
- No: individual participant data (IPD) available to other researchers could be gotten from the PI Dr. aijun XU
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Bispectral Index Guided Remimazolam Total Intravenous Anesthesia-flumazenil Antagonism in Short-duration Ear Nose Throat Surgeries: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07389798
- Acronym / sponsor ID
- TIVA / RTFA
- Conditions
- Remimazolam, Total Intravenous Anesthesia, Bispectral Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 29 Mar 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 5 Feb 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 study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism based on whether their intraoperative BIS values were maintained below 60.
Detailed description
This study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism into two groups based on whether their intraoperative BIS values were maintained below 60. It aims to compare the differences in postoperative recovery quality between the groups, thereby providing evidence-based support for determining the optimal BIS target range during remimazolam TIVA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB group | – | –Intraoperative BIS values ≤60 |
| HB group | – | –Intraoperative BIS values >60 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age 18-65 years
- ASA I-III
- Underwent short-duration ENT surgery
- Underwent remimazolam TIVA combined with flumazenil antagonism.
- Continuous intraoperative BIS monitoring
Key exclusion criteria (3 listed)
- Comorbid severe underlying diseases
- Intraoperative BIS data were missing or incompletely recorded
- Severe lack of medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of intraoperative awareness
Time frame: 2hours
Modified Brice Interview From the start of surgery to the end of surgery
7 secondary outcomes
Incidence of secondary sedation
Time frame: 1 day
mean arterial pressure
Time frame: 2 hours
heart rate
Time frame: 2 hours
usage of vasoactive drugs
Time frame: 2 hours
Drug doses
Time frame: 2 hours
Awakening time
Time frame: 1 hours
PACU stay
Time frame: 1 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. individual participant data (IPD) available to other researchers could be gotten from the PI Dr. aijun XU
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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. This study is not recruiting at the moment.
Aihua Du, Dr study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Remimazolam and Total Intravenous Anesthesia, run by Tongji Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative awareness (time frame: 2hours). 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 11 May 2026.