Impact of Flumazenil on the Emergence Delirium

NCT05681377 | Completed Phase 4

• 1 other identifier: 2022GR0520
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, General

Keywords

Remimazolam, Flumazenil, Emergence delirium, Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence delirium

  Richmond Agitation \& Sedation Scale (RASS) ≥1 is considered emergence delirium.

  From emergence to postanesthesia care unit (PACU) discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery]

Secondary Outcomes (11)

• Incidence of postoperative delirium (POD)

  From PACU to postoperative day 5(until the discharge date if discharged before 5 days after surgery) [2 times a day in the morning/afternoon]

• Severity of POD

  From PACU to postoperative day 5

• Duration of POD

  From PACU to postoperative day 5

• Level of consciousness

  From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery

• Incidence of resedation

  From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery

Study Arms (2)

Flumazenil group

EXPERIMENTAL

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

Drug: Flumazenil

Control group

NO INTERVENTION

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

Interventions

Flumazenil DRUG

After cessation of remimazolam infusion, flumazenil 0.2 mg is administered intravenously over 15 seconds. If consciousness is not adequately restored within 3-5 minutes, a second dose of 0.1 mg intravenously over 15 seconds is administered. If necessary, 0.1 mg may be administered repeatedly at 3-5 minute intervals, and the maximum dose of 1 mg should not be exceeded.

Flumazenil group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Interventions

Flumazenil

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Byung Gun Lim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: March 5, 2023
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)