Clinical trial NCT05939674: Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam
Official title: Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flumazenil Adverse Reaction
Remimazolam
Hip Joint
Elderly Patients
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility 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

Primary outcomes:
measure: Difference in eye opening time between the two groups
timeFrame: Up to two hours
measure: Difference in extubation time between the two groups
timeFrame: Up to two hours
Secondary outcomes:
measure: Actual dose of flumazenil
timeFrame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
measure: Occurrence of re-sedation
timeFrame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
measure: Side effects of flumazenil usage
timeFrame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sangwook Shin, MD. PhD
role: STUDY_DIRECTOR
References: