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NCT05681377
Impact of Flumazenil on the Emergence Delirium
Conditions: Anesthesia, General
Sex: All
Ages: 19 Years – N/A
Phase: PHASE4
Enrollment: 68
Sponsor: Korea University Guro Hospital
Location: Korea, Republic of
Summary
Flumazenil rapidly antagonizes benzodiazepines (BZDs); it may induce agitation, seizure, or delirium, especially when applied to patients who have taken BZDs for a long time.
On the contrary, it may help patients regain consciousness in a stable and calm state by appropriately reversing the central nervous system depressant effects of BZDs.
In this study, we aim to investigate the impact of flumazenil on the emergence delirium in patients anesthetized with remimazolam, the short-acting BZD drug.
Eligibility Criteria
Inclusion Criteria:Adult patients aged 19 years or older undergoing surgery under general anesthesiaExclusion Criteria:Peripheral nerve block or Neuraxial blockUncontrolled hypertension (HTN) (systolic blood pressure (SBP) ≥180 mmHg)Uncontrolled diabetes mellitus (DM) (HbA1c ≥9.0%)Hepatic dysfunction (Total bilirubin ≥3.0 mg/mL or Liver enzyme ≥Upper normal limit x 2.5)Renal dysfunction (Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2
or Dialysis)Moderate or severe chronic obstructive pulmonary disease or Respiratory failureEmergencyHepatectomy or Liver transplantationIntraoperative cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) useHead trauma, Increased intracranial pressure, CraniotomyChronic use of benzodiazepines (BZDs)Anxiety, Alcohol/Drug dependence, Addiction to tricyclic antidepressants (TCAs)Allergic reaction to BZDs, flumazenil, or other drugs used in general anesthesiaSevere allergy or Anaphylaxis historyLactose-related genetic disordersMyasthenia gravis or Myasthenia gravis syndromeMyocardial infarction or Cerebrovascular events within 6 monthsSymptomatic coronary artery diseaseOrganic brain diseaseCognitive impairment (Inability to understand informed consent)
Source: ClinicalTrials.gov (NCT05681377). StuddyBuddy aggregates publicly available trial information.