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NCT Number: NCT05681377

Impact of Flumazenil on the Emergence Delirium

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Incidence of emergence delirium

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

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

Secondary outcomes

  1. Incidence of postoperative delirium (POD)

    Time frame: 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]

    3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) is used for the evaluation of POD.

  2. Severity of POD

    Time frame: From PACU to postoperative day 5

    CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs.

  3. Duration of POD

    Time frame: From PACU to postoperative day 5

    3D-CAM is utilized to check the duration of POD.

  4. Level of consciousness

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

    Richmond Agitation & Sedation Scale (RASS) is used to evaluate the patients level of consciousness.

  5. Incidence of resedation

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

    Richmond Agitation & Sedation Scale (RASS) ≤-2 is diagnosed as resedation.

  6. Time to eye-opening

    Time frame: After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]

    Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam.

  7. Time to extubation

    Time frame: After remimazolam cessation to extubation [within 30 min after remimazolam cessation]

    Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation.

  8. Preoperative anxiety

    Time frame: 1 day before surgery

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery

  9. Postoperative nausea/vomiting (PONV)

    Time frame: From immediately after extubation to PACU discharge [within 2 hours after surgery]

    Confirm PONV through patient's symptoms and signs.

  10. Postoperative pain

    Time frame: From PACU admission to postoperative day 5

    Numeric rating scale (NRS) or Visual analogue scale (VAS) is used to determine the patient's pain severity (*NRS and VAS are measured on a 0-10 scale, and the higher the score, the more severe the patient's pain)

  11. Postoperative hospital length of stay

    Time frame: From the day of surgery to the day of hospital discharge [within 1 month]

    Calculate the days from the date of surgery to the date of hospital discharge.

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

The Impact of Administration of Flumazenil on the Emergence Delirium in Patients Anesthetized With Remimazolam: a Prospective Randomized Single-blind Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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