Remimazolam TIVA-Flumazenil Antagonism in Short-duration ENT Surgeries (TIVA)

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.

Study Overview

• Status: Completed
• Conditions: Total Intravenous Anesthesia; Remimazolam; Bispectral Index

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 Type: Observational
• Enrollment (Actual): 511

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AB group; Intraoperative BIS values ≤60
HB group; Intraoperative BIS values >60

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	2 hours
heart rate	The fluctuation range of intraoperative heart rate during surgery	2 hours
usage of vasoactive drugs	Intraoperative use of vasoactive drugs during surgery	2 hours
Drug doses	Drug doses during surgery	2 hours
Awakening time	From the end of anesthesia to awakening.	1 hours
PACU stay	From admission to the PACU to discharge from the PACU.	1 hours

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: Aihua Du, Dr, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Actual): March 29, 2026
• Study Completion (Actual): April 4, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RTFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data (IPD) available to other researchers could be gotten from the PI Dr. aijun XU