Elderly Patients, Flumazenil Adverse Reaction, Hip Joint, Remimazolam
Conditions
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
Interventions
DRUGFlumazenil
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.
DRUGnormal 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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Actual dose of flumazenil | Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit | Actual dose of flumazenil |
| 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) |
| 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 |
Countries
South Korea
Contacts
Primary ContactJaesang BAE, MD
Outcome results
None listed