Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

NCT ID: NCT05939674

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2026-06-30

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.

Detailed Description

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

Conditions

Flumazenil Adverse Reaction; Remimazolam; Hip Joint; Elderly Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Normal saline group

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: 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.

Flumazenil group

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

Group Type: ACTIVE_COMPARATOR

Flumazenil

Intervention Type: 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.

Interventions

Flumazenil

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.

Intervention Type: DRUG

normal saline

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.

Intervention Type: DRUG

Other Intervention Names

Flumazenil, Flunil, Bukwang Pharm Co., Ltd; Normal saline inj (JW)

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

SANGWOOK SHIN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sangwook Shin, MD. PhD

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jaesang BAE, MD

Role: CONTACT

wotkdqo@gmail.com

820553602129

Facility Contacts

SANGWOOK SHIN, MD, PhD

Role: primary

shinsw@pusan.ac.kr

82-055-360-2129

Other Identifiers

05-2023-134

Identifier Type: -

Identifier Source: org_study_id