Impact of Flumazenil on the Emergence Delirium

Phase 4

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: Flumazenil

• Registration Number: NCT05681377
• Lead Sponsor: Korea University Guro Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2022-12-28
• Study First Posted: 2023-01-12
• Study Start: 2023-03-05
• Primary Completion: 2023-08-11
• Study Completion: 2023-08-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flumazenil group	Flumazenil	After discontinuation of remimazolam administration, flumazenil is administered to help the patient recover consciousness.

Primary Outcome Measures

Name	Time	Method
Incidence of 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]	Richmond Agitation \& Sedation Scale (RASS) ≥1 is considered emergence delirium.

Secondary Outcome Measures

Name	Time	Method
Duration of POD	From PACU to postoperative day 5	3D-CAM is utilized to check the duration of POD.
Incidence of resedation	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.
Time to eye-opening	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.
Postoperative nausea/vomiting (PONV)	From immediately after extubation to PACU discharge [within 2 hours after surgery]	Confirm PONV through patient's symptoms and signs.
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]	3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) is used for the evaluation of POD.
Severity of POD	From PACU to postoperative day 5	CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs.
Level of consciousness	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.
Postoperative pain	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)
Time to extubation	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.
Preoperative anxiety	1 day before surgery	Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery
Postoperative hospital length of stay	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.

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of