Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flumazenil, normal saline.
- Who it may be relevant to
- Registry conditions: Flumazenil Adverse Reaction, Remimazolam, Hip Joint, Elderly Patients. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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
- Drug Flumazenil
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. - Drug normal 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.
Primary outcome measures
- Difference in eye opening time between the two groups [Time frame: Up to two hours]
- Difference in extubation time between the two groups [Time frame: Up to two hours]
Secondary outcome measures (3)
- Actual dose of flumazenil [Time frame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit]
- Occurrence of re-sedation [Time frame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit]
- Side effects of flumazenil usage [Time frame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Pusan National University Yangsan Hospital — Yangsan
Identifiers
NCT: NCT05939674 · 05-2023-134