Anesthesia, GeneralPhase 4NCT05681377
Impact of Flumazenil on the Emergence Delirium
A Phase 4 study testing Flumazenil in people with Anesthesia, General, run by Korea University Guro Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Flumazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2023to 11 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 years or older undergoing surgery under general anesthesia
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Administration of Flumazenil on the Emergence Delirium in Patients Anesthetized With Remimazolam: a Prospective Randomized Single-blind Study
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.
- Conditions
- Anesthesia, General
- Being tested
- Flumazenil
- Keywords
- Remimazolam, Flumazenil, Emergence delirium, Delirium
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Flumazenil group | Experimental | After discontinuation of remimazolam administration, flumazenil is administered to help the patient recover consciousness. Receives: Drug: Flumazenil |
| Control group | No intervention | After discontinuation of remimazolam administration, wait until the patient's consciousness is restored naturally without flumazenil administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium
Richmond Agitation \& Sedation Scale (RASS) ≥1 is considered emergence delirium.
Measured: 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 (11)
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.
Measured: 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]
Severity of POD
CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs.
Measured: From PACU to postoperative day 5
Duration of POD
3D-CAM is utilized to check the duration of POD.
Measured: From PACU to postoperative day 5
Level of consciousness
Richmond Agitation \& Sedation Scale (RASS) is used to evaluate the patients level of consciousness.
Measured: From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Incidence of resedation
Richmond Agitation \& Sedation Scale (RASS) ≤-2 is diagnosed as resedation.
Measured: From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Time to eye-opening
Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam.
Measured: After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]
Time to extubation
Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation.
Measured: After remimazolam cessation to extubation [within 30 min after remimazolam cessation]
Preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery
Measured: 1 day before surgery
Postoperative nausea/vomiting (PONV)
Confirm PONV through patient's symptoms and signs.
Measured: From immediately after extubation to PACU discharge [within 2 hours after surgery]
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)
Measured: From PACU admission to postoperative day 5
Postoperative hospital length of stay
Calculate the days from the date of surgery to the date of hospital discharge.
Measured: From the day of surgery to the day of hospital discharge [within 1 month]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start5 Mar 2023
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung Gun Lim, Korea University Guro Hospital
- Investigators
- Byung Gun Lim, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681377
- Sponsor's protocol ID
- 2022GR0520
- Status last verified
- Sep 2023
- First submitted
- 28 Dec 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans yet to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Administration of Flumazenil on the Emergence Delirium in Patients Anesthetized With Remimazolam: a Prospective Randomized Single-blind Study
- ClinicalTrials.gov ID
- NCT05681377
- Acronym / sponsor ID
- 2022GR0520
- Conditions
- Anesthesia, General
- Keywords
- Remimazolam, Flumazenil, Emergence delirium, Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flumazenil group | Experimental | Drug: FlumazenilAfter discontinuation of remimazolam administration, flumazenil is administered to help the patient recover consciousness. |
| Control group | No intervention | –After discontinuation of remimazolam administration, wait until the patient's consciousness is restored naturally without flumazenil administration. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 19 years or older undergoing surgery under general anesthesia
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlumazenilAfter 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. | Drug | Flumazenil group |
Primary outcome
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.
11 secondary outcomes
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]
Severity of POD
Time frame: From PACU to postoperative day 5
Duration of POD
Time frame: From PACU to postoperative day 5
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
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
Time to eye-opening
Time frame: After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]
Time to extubation
Time frame: After remimazolam cessation to extubation [within 30 min after remimazolam cessation]
Preoperative anxiety
Time frame: 1 day before surgery
Postoperative nausea/vomiting (PONV)
Time frame: From immediately after extubation to PACU discharge [within 2 hours after surgery]
Postoperative pain
Time frame: From PACU admission to postoperative day 5
Postoperative hospital length of stay
Time frame: From the day of surgery to the day of hospital discharge [within 1 month]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No. We have no plans yet to share individual participant data (IPD) with other researchers.
Related trials for Anesthesia, General
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung Gun Lim, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flumazenil in people with Anesthesia, General, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.