Clinical trial NCT05681377: Impact of Flumazenil on the Emergence Delirium
Official title: The Impact of Administration of Flumazenil on the Emergence Delirium in Patients Anesthetized With Remimazolam: a Prospective Randomized Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, General
Keywords: Remimazolam, Flumazenil, Emergence delirium, Delirium
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Incidence of emergence delirium
timeFrame: 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:
measure: Incidence of postoperative delirium (POD)
timeFrame: 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]
measure: Severity of POD
timeFrame: From PACU to postoperative day 5
measure: Duration of POD
timeFrame: From PACU to postoperative day 5
measure: Level of consciousness
timeFrame: From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
measure: Incidence of resedation
timeFrame: From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
measure: Time to eye-opening
timeFrame: After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]
measure: Time to extubation
timeFrame: After remimazolam cessation to extubation [within 30 min after remimazolam cessation]
measure: Preoperative anxiety
timeFrame: 1 day before surgery
measure: Postoperative nausea/vomiting (PONV)
timeFrame: From immediately after extubation to PACU discharge [within 2 hours after surgery]
measure: Postoperative pain
timeFrame: From PACU admission to postoperative day 5
measure: Postoperative hospital length of stay
timeFrame: From the day of surgery to the day of hospital discharge [within 1 month]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Byung Gun Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: