Impact of Flumazenil on the Emergence Delirium

Korea University

Status and phase: Completed; Phase 4

Conditions: Anesthesia, General

Treatments: Drug: Flumazenil

Study type: Interventional

Funder types: Other

Identifiers

NCT05681377

2022GR0520

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Flumazenil group

Experimental group

Description:

After discontinuation of remimazolam administration, flumazenil is administered to help the patient recover consciousness.

Treatment:

Drug: Flumazenil

Control group

No Intervention group

Description:

After discontinuation of remimazolam administration, wait until the patient's consciousness is restored naturally without flumazenil administration.