Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPusan National University Yangsan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 65 years old scheduled for hip joint surgery
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Flumazenil
DrugDuring 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.
normal saline
DrugDuring 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Normal saline groupPlacebo comparator 1 intervention
Group B: Flumazenil groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in eye opening time between the two groups
Time, after stopping injection of remimazolam, to eye opening
Time frame
Up to two hours2
Difference in extubation time between the two groups
Time, after stopping injection of remimazolam, to extubation
Time frame
Up to two hoursSecondary outcomes
1
Actual dose of flumazenil
Actual dose of flumazenil
Time frame
Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit2
Occurrence of re-sedation
Richmond Agitation Sedation Scale (RASS) score of -3 or lower(Score range: -5\~+4, lower score means more sedated state)
Time frame
Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit3
Side effects of flumazenil usage
Number of Participants with Seizures, agitation, arrhythmias, gastrointestinal symptoms, post operative nausea and vomiting, and degree of pain
Time frame
Up to two hours, From end of anesthesia to discharge form the post-anestheic care unitSponsors and contacts
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Source ClinicalTrials.gov