NCT07389798

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

27 days

First QC Date

January 21, 2026

Last Update Submit

March 1, 2026

Conditions

RemimazolamTotal Intravenous AnesthesiaBispectral Index

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative awareness

    Modified Brice Interview From the start of surgery to the end of surgery

    2hours

Secondary Outcomes (7)

  • Incidence of secondary sedation

    1 day

  • mean arterial pressure

    2 hours

  • heart rate

    2 hours

  • usage of vasoactive drugs

    2 hours

  • Drug doses

    2 hours

  • +2 more secondary outcomes

Study Arms (2)

AB group

Intraoperative BIS values ≤60

HB group

Intraoperative BIS values \>60

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 18-65 years
  • ASA I-III
  • Underwent short-duration ENT surgery
  • Underwent remimazolam TIVA combined with flumazenil antagonism.
  • Continuous intraoperative BIS monitoring

You may not qualify if:

  • Comorbid severe underlying diseases
  • Intraoperative BIS data were missing or incompletely recorded
  • Severe lack of medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Aihua Du, Dr

    Tongji Hospital

    STUDY CHAIR

Central Study Contacts

mujun chang, Dr

CONTACT

+862783663625changmujun@hotmail.com

aihua Du, Dr

CONTACT

+862783663625tongjihlunli@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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