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NCT Number: NCT05939674

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

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.

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Key information

Conditions

Flumazenil Adverse Reaction Elderly Patients Hip Joint Remimazolam

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location status: Recruiting

Location contact

SANGWOOK SHIN, MD, PhD

CONTACT

[email protected]

82-055-360-2129

About this study

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.

Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.

However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.

Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.

Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 65 years old scheduled for hip joint surgery

Exclusion criteria

  • 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

Treatment and study plan

Flumazenil

Drug

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.

Other names: Flumazenil, Flunil, Bukwang Pharm Co., Ltd

normal saline

Drug

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.

Other names: Normal saline inj (JW)

Primary outcomes

  1. Difference in eye opening time between the two groups

    Time frame: Up to two hours

    Time, after stopping injection of remimazolam, to eye opening

  2. Difference in extubation time between the two groups

    Time frame: Up to two hours

    Time, after stopping injection of remimazolam, to extubation

Secondary outcomes

  1. Actual dose of flumazenil

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

    Actual dose of flumazenil

  2. Occurrence of re-sedation

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

    Richmond Agitation Sedation Scale (RASS) score of -3 or lower(Score range: -5~+4, lower score means more sedated state)

  3. Side effects of flumazenil usage

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

    Number of Participants with Seizures, agitation, arrhythmias, gastrointestinal symptoms, post operative nausea and vomiting, and degree of pain

Study contacts

Contact information is provided by the study sponsor or research team.

Jaesang BAE, MD

CONTACT

[email protected]

820553602129

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2023
Registry last updated
Sep 12, 2025

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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