Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Not Applicable

Recruiting

• Conditions: Remimazolam; Hip Joint; Flumazenil Adverse Reaction; Elderly Patients
• Interventions: Drug: normal saline; Drug: Flumazenil

• Registration Number: NCT05939674
• Lead Sponsor: Pusan National University Yangsan Hospital

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

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-07-02
• Study First Posted: 2023-07-11
• Study Start: 2023-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline group	normal saline	Participants are administered 3mL of 0.9% normal saline at the end of anesthesia
Flumazenil group	Flumazenil	Participants are administered 0.3mg(3mL) of flumazenil at the end of anesthesia

Primary Outcome Measures

Name	Time	Method
Difference in eye opening time between the two groups	Up to two hours	Time, after stopping injection of remimazolam, to eye opening
Difference in extubation time between the two groups	Up to two hours	Time, after stopping injection of remimazolam, to extubation

Secondary Outcome Measures

Name	Time	Method
Actual dose of flumazenil	Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit	Actual dose of flumazenil
Side effects of flumazenil usage	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
Occurrence of re-sedation	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)

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangnamdo, Korea, Republic of