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Completed

NCT Number: NCT07389798

Remimazolam TIVA-Flumazenil Antagonism in Short-duration ENT Surgeries

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.

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Key information

Conditions

Remimazolam Bispectral Index Total Intravenous Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of intraoperative awareness

    Time frame: 2hours

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

Secondary outcomes

  1. Incidence of secondary sedation

    Time frame: 1 day

    Incidence of secondary sedation from flumazenil antagonization to discharge from the PACU

  2. mean arterial pressure

    Time frame: 2 hours

    The fluctuation range of intraoperative mean arterial pressure during surgery

  3. heart rate

    Time frame: 2 hours

    The fluctuation range of intraoperative heart rate during surgery

  4. usage of vasoactive drugs

    Time frame: 2 hours

    Intraoperative use of vasoactive drugs during surgery

  5. Drug doses

    Time frame: 2 hours

    Drug doses during surgery

  6. Awakening time

    Time frame: 1 hours

    From the end of anesthesia to awakening.

  7. PACU stay

    Time frame: 1 hours

    From admission to the PACU to discharge from the PACU.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Acronym: TIVA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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