Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Remimazolam; Hip Joint; Flumazenil Adverse Reaction; Elderly Patients

Treatments: Drug: normal saline; Drug: Flumazenil

Study type: Interventional

Funder types: Other

Identifiers

NCT05939674

05-2023-134

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Normal saline group

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline

Flumazenil group

Active Comparator group

Description:

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

Treatment:

Drug: Flumazenil