Remimazolam TIVA-Flumazenil Antagonism in Short-duration... | NCT07389798

Studies
Remimazolam TIVA-Flumazenil Antagonism in Short-duration ENT Surgeries

NCT07389798

Sponsor

Tongji Hospital

Status

Completed

Last Update Posted

May 11, 2026Actual

Enrollment

511Actual

Phase

Not provided

Conditions

Remimazolam
Total Intravenous Anesthesia
Bispectral Index

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2026Actual

Primary Completion Date

Mar 29, 2026Actual

Completion Date

Apr 4, 2026Actual

First Submitted Date

Jan 21, 2026

First Submission Date that Met QC Criteria

Jan 29, 2026

First Posted Date

Feb 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2026

Last Update Posted Date

May 11, 2026Actual

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

511Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AB group		Intraoperative BIS values ≤60
HB group		Intraoperative BIS values >60

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of intraoperative awareness	Modified Brice Interview From the start of surgery to the end of surgery	2hours

Secondary Outcomes

Measure	Description	Time Frame
Incidence of secondary sedation	Incidence of secondary sedation from flumazenil antagonization to discharge from the PACU	1 day
mean arterial pressure	The fluctuation range of intraoperative mean arterial pressure during surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aihua Du, Dr	Tongji Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

individual participant data (IPD) available to other researchers could be gotten from the PI Dr. aijun XU

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided