Overview

Impact of Flumazenil on the Emergence Delirium

Status:
Not yet recruiting
Trial end date:
2023-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korea University Guro Hospital
Treatments:
Flumazenil
Criteria
Inclusion Criteria:

- Adult patients aged 19 years or older undergoing surgery under general anesthesia

Exclusion Criteria:

- Peripheral nerve block or Neuraxial block

- Uncontrolled 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 failure

- Emergency

- Hepatectomy or Liver transplantation

- Intraoperative cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation
(ECMO) use

- Head trauma, Increased intracranial pressure, Craniotomy

- Chronic use of benzodiazepines (BZDs)

- Anxiety, Alcohol/Drug dependence, Addiction to tricyclic antidepressants (TCAs)

- Allergic reaction to BZDs, flumazenil, or other drugs used in general anesthesia

- Severe allergy or Anaphylaxis history

- Lactose-related genetic disorders

- Myasthenia gravis or Myasthenia gravis syndrome

- Myocardial infarction or Cerebrovascular events within 6 months

- Symptomatic coronary artery disease

- Organic brain disease

- Cognitive impairment (Inability to understand informed consent)