Investigating Flumazenil's Effects on Recovery from Anesthesia with Remimazolam
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.
NA · Pusan National University Yangsan Hospital · NCT05939674
This study tests if using flumazenil after remimazolam anesthesia helps older patients recover faster and reduces memory problems after hip surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital (other) |
| Locations | 1 site (Yangsan, Gyeongsangnam-do) |
| Trial ID | NCT05939674 on ClinicalTrials.gov |
What this trial studies
This study examines the necessity of using flumazenil, a reversal agent, after administering remimazolam for total intravenous anesthesia in elderly patients undergoing hip joint surgery. It aims to evaluate the impact of flumazenil on recovery time and the occurrence of postoperative cognitive dysfunction. The research will consider factors such as age, obesity, and plasma albumin levels that may affect recovery. By comparing flumazenil with normal saline, the study seeks to clarify its role in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are patients over 65 years old scheduled for hip joint surgery.
Not a fit: Patients with impaired consciousness, hemodynamic instability, or certain neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and reduced cognitive dysfunction in elderly patients after anesthesia.
How similar studies have performed: While flumazenil is commonly used in clinical settings, this specific investigation into its routine use with remimazolam is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yangsan, Gyeongsangnam-do
- Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jaesang BAE, MD
- Email: wotkdqo@gmail.com
- Phone: 820553602129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Flumazenil Adverse Reaction, Remimazolam, Hip Joint, Elderly Patients