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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05681377
Other study ID # 2022GR0520
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 5, 2023
Est. completion date August 11, 2023

Study information

Verified date September 2023
Source Korea University Guro Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date August 11, 2023
Est. primary completion date August 11, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Flumazenil
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.

Locations

Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence of postoperative delirium (POD) 3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) is used for the evaluation of 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]
Secondary Severity of POD CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs. From PACU to postoperative day 5
Secondary Duration of POD 3D-CAM is utilized to check the duration of POD. From PACU to postoperative day 5
Secondary Level of consciousness Richmond Agitation & Sedation Scale (RASS) is used to evaluate the patients level of consciousness. From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Secondary Incidence of resedation Richmond Agitation & Sedation Scale (RASS) =-2 is diagnosed as resedation. From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Secondary Time to eye-opening Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam. After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]
Secondary Time to extubation Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation. After remimazolam cessation to extubation [within 30 min after remimazolam cessation]
Secondary Preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery 1 day before surgery
Secondary Postoperative nausea/vomiting (PONV) Confirm PONV through patient's symptoms and signs. From immediately after extubation to PACU discharge [within 2 hours after surgery]
Secondary Postoperative pain 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) From PACU admission to postoperative day 5
Secondary Postoperative hospital length of stay Calculate the days from the date of surgery to the date of hospital discharge. From the day of surgery to the day of hospital discharge [within 1 month]
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