NCT05939674

Brief Summary

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

June 22, 2023

Last Update Submit

September 7, 2025

Conditions

Flumazenil Adverse ReactionRemimazolamHip JointElderly Patients

Outcome Measures

Primary Outcomes (2)

  • Difference in eye opening time between the two groups

    Time, after stopping injection of remimazolam, to eye opening

    Up to two hours

  • Difference in extubation time between the two groups

    Time, after stopping injection of remimazolam, to extubation

    Up to two hours

Secondary Outcomes (3)

  • Actual dose of flumazenil

    Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit

  • Occurrence of re-sedation

    Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit

  • Side effects of flumazenil usage

    Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit

Study Arms (2)

Normal saline group

PLACEBO COMPARATOR

Participants are administered 3mL of 0.9% normal saline at the end of anesthesia

Drug: normal saline

Flumazenil group

ACTIVE COMPARATOR

Participants are administered 0.3mg(3mL) of flumazenil at the end of anesthesia

Drug: Flumazenil

Interventions

FlumazenilDRUG

During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.3mg of flumazenil according to allocated groups.

Also known as: Flumazenil, Flunil, Bukwang Pharm Co., Ltd
Flumazenil group
normal salineDRUG

During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.9% normal saline according to allocated groups.

Also known as: Normal saline inj (JW)
Normal saline group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients over 65 years old scheduled for hip joint surgery

You may not qualify if:

  • Patients with impaired consciousness or delirium before surgery
  • Patients who are hemodynamically unstable before surgery
  • Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
  • Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
  • Patients with known allergy to benzodiazepine, flumazenil
  • Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Patients with hypersensitivity to Dextran40
  • Patients who have been taking benzodiazepine for long term
  • Patients with end stage renal disease requiring hemodialysis
  • Patients with history of acute angle glaucoma
  • Patients with alcohol or substance dependence
  • ASA classification 4 or 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Interventions

FlumazenilLong-Term Synaptic DepressionSaline Solution

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sangwook Shin, MD. PhD

    Pusan National University Yangsan Hospital

    STUDY DIRECTOR

Central Study Contacts

Jaesang BAE, MD

CONTACT

820553602129wotkdqo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 11, 2023

Study Start

September 19, 2023

Primary Completion

February 1, 2026

Study Completion

June 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

KR(1)