Actively Recruiting
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study
Led by Pusan National University Yangsan Hospital · Updated on 2025-09-12
24
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery. Remimazolam is a medication known for its short half-life and reversibility with flumazenil, but routine use of flumazenil is not currently recommended due to potential side effects such as rebound sedation and cardiac events. This study aims to clarify the necessity and impact of routinely using flumazenil in this setting, especially considering factors that may delay recovery like advanced age and obesity. Participants receive remimazolam combined with remifentanil for anesthesia. At the end of the procedure, they are randomly assigned to receive either 0.3 mg of flumazenil or 3 mL of normal saline (placebo). Anesthesia is induced with remimazolam at 6 mg/kg/h and maintained at 1-2 mg/kg/h alongside remifentanil. The study compares recovery times and side effects between these two groups. During the study, participants are monitored for up to two hours after anesthesia to measure eye-opening and extubation times. Researchers also assess flumazenil dosage, any re-sedation episodes, and side effects from the drug until discharge from the post-anesthetic care unit. This randomized, double-blind trial involves older adults and includes careful observation of recovery and safety outcomes related to flumazenil use after remimazolam anesthesia.
CONDITIONS
Brief Title
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 65 years old scheduled for hip joint surgery
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and up to 2 hours post-anesthesia
Participants undergo hip joint surgery under total intravenous anesthesia with remimazolam. At the end of anesthesia, participants receive either flumazenil or normal saline as a reversal agent.
1 surgery day visit and monitoring for up to 2 hours post-anesthesia
Trial Site Locations
Total: 1 location
1
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
Research Team
J
Jaesang BAE, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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