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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flumazenil group | Experimental | After 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumazenil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung Gun Lim, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
We have no plans yet to share individual participant data (IPD) with other researchers.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005442 | Flumazenil |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Severity of POD |
CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs. |
| From PACU to postoperative day 5 |
| Duration of POD | 3D-CAM is utilized to check the duration of POD. | From PACU to postoperative day 5 |
| 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 |
| 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 |
| 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] |
| 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] |
| Preoperative anxiety | Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery | 1 day before surgery |
| Postoperative nausea/vomiting (PONV) | Confirm PONV through patient's symptoms and signs. | 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) | 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. | From the day of surgery to the day of hospital discharge [within 1 month] |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |