search
Back to results

Impact of Flumazenil on the Emergence Delirium

Primary Purpose

Anesthesia, General

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Flumazenil
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia, General focused on measuring Remimazolam, Flumazenil, Emergence delirium, Delirium

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Flumazenil group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Severity of POD
CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs.
Duration of POD
3D-CAM is utilized to check the duration of POD.
Level of consciousness
Richmond Agitation & Sedation Scale (RASS) is used to evaluate the patients level of consciousness.
Incidence of resedation
Richmond Agitation & Sedation Scale (RASS) ≤-2 is diagnosed as resedation.
Time to eye-opening
Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam.
Time to extubation
Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation.
Preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery
Postoperative nausea/vomiting (PONV)
Confirm PONV through patient's symptoms and signs.
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)
Postoperative hospital length of stay
Calculate the days from the date of surgery to the date of hospital discharge.

Full Information

First Posted
December 28, 2022
Last Updated
September 3, 2023
Sponsor
Korea University Guro Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05681377
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General
Keywords
Remimazolam, Flumazenil, Emergence delirium, Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flumazenil group
Arm Type
Experimental
Arm Description
After discontinuation of remimazolam administration, flumazenil is administered to help the patient recover consciousness.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
After discontinuation of remimazolam administration, wait until the patient's consciousness is restored naturally without flumazenil administration.
Intervention Type
Drug
Intervention Name(s)
Flumazenil
Intervention Description
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 Outcome Measure Information:
Title
Incidence of emergence delirium
Description
Richmond Agitation & Sedation Scale (RASS) ≥1 is considered 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]
Secondary Outcome Measure Information:
Title
Incidence of postoperative delirium (POD)
Description
3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) is used for the evaluation of 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]
Title
Severity of POD
Description
CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs.
Time Frame
From PACU to postoperative day 5
Title
Duration of POD
Description
3D-CAM is utilized to check the duration of POD.
Time Frame
From PACU to postoperative day 5
Title
Level of consciousness
Description
Richmond Agitation & Sedation Scale (RASS) is used to evaluate the patients 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
Title
Incidence of resedation
Description
Richmond Agitation & Sedation Scale (RASS) ≤-2 is diagnosed as resedation.
Time Frame
From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Title
Time to eye-opening
Description
Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam.
Time Frame
After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]
Title
Time to extubation
Description
Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation.
Time Frame
After remimazolam cessation to extubation [within 30 min after remimazolam cessation]
Title
Preoperative anxiety
Description
Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery
Time Frame
1 day before surgery
Title
Postoperative nausea/vomiting (PONV)
Description
Confirm PONV through patient's symptoms and signs.
Time Frame
From immediately after extubation to PACU discharge [within 2 hours after surgery]
Title
Postoperative pain
Description
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 Frame
From PACU admission to postoperative day 5
Title
Postoperative hospital length of stay
Description
Calculate the days from the date of surgery to the date of hospital discharge.
Time Frame
From the day of surgery to the day of hospital discharge [within 1 month]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung Gun Lim, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have no plans yet to share individual participant data (IPD) with other researchers.

Learn more about this trial

Impact of Flumazenil on the Emergence Delirium

We'll reach out to this number within 24 hrs