Remimazolam TIVA-Flumazenil Antagonism in Short-duration ENT Surgeries

Different Bispectral Index Guided Remimazolam Total Intravenous Anesthesia-flumazenil Antagonism in Short-duration Ear Nose Throat Surgeries: A Retrospective Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07389798

Acronym

TIVA

Enrollment

511

Registered

2026-02-05

Start date

2026-03-09

Completion date

2026-04-04

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bispectral Index, Remimazolam, Total Intravenous Anesthesia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Incidence of secondary sedation	1 day	Incidence of secondary sedation from flumazenil antagonization to discharge from the PACU
mean arterial pressure	2 hours	The fluctuation range of intraoperative mean arterial pressure during surgery
heart rate	2 hours	The fluctuation range of intraoperative heart rate during surgery
usage of vasoactive drugs	2 hours	Intraoperative use of vasoactive drugs during surgery
Drug doses	2 hours	Drug doses during surgery
Awakening time	1 hours	From the end of anesthesia to awakening.
PACU stay	1 hours	From admission to the PACU to discharge from the PACU.

Countries

China

Contacts

STUDY_CHAIRAihua Du, Dr

Tongji Hospital

Outcome results