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| Name | Class |
|---|---|
| Hana Pharm Co., Ltd. | INDUSTRY |
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The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.
The main questions it aims to answer are:
Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?
Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?
Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eleveld model-guided dosing | Experimental |
| |
| Standard weight-based label dosing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eleveld model-guided dosing | Drug | Eleveld model-guided dosing via a validated web-based calculator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eye-Opening Time, EOT | Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h |
| Measure | Description | Time Frame |
|---|---|---|
| Time to loss of consciousness (LOC) | Time from the start of remimazolam administration to loss of consciousness (min), up to 1h | |
| Intraoperative Bispectral Index (BIS) values | Perioperative/Periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hansol Kim, M.D. | Contact | +82-2-2072-2467 | hansolfrkr@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
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| Standard weight-based label dosing | Drug | Induction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h |
|
| Incidence of intraoperative bradycardia (heart rate < 45 bpm) | Perioperative/Periprocedural |
| Incidence of intraoperative tachycardia (heart rate > 110) | Perioperative/Periprocedural |
| Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg) | Perioperative/Periprocedural |
| Incidence of intraoperative hypertension (SBP > 140 mmHg) | Perioperative/Periprocedural |
| Total dose of intraoperative remimazolam (mg) | Perioperative/Periprocedural |
| Total dose of intraoperative remifentanil (㎍) | Perioperative/Periprocedural |
| Total dose(s) of intraoperative vasopressor(s) | Ephedrine (mg) | Perioperative/Periprocedural |
| Extubation time (min) | Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h |
| Incidence of flumazenil administration | From discontinuation of remimazolam to patient discharge from the operating room, up to 1h |
| Incidence of rescue sevoflurane use | Perioperative/Periprocedural |
| Incidence of oxygen supplementation in the Post-Anesthesia Care Unit (PACU) | Perioperative/Periprocedural, on the day of surgery |
| Incidence of postoperative delirium | Perioperative/Periprocedural, up to 1 week |
| Incidence of postoperative nausea and vomiting (PONV) | Perioperative/Periprocedural, up to 1 week |
| Length of stay in the PACU (min) | Perioperative/Periprocedural, on the day of surgery |
| Incidence of re-sedation | Drop in the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score to 3 or lower during the PACU stay | Perioperative/Periprocedural, on the day of surgery |
| Incidence of intraoperative awareness | assessed using the Modified Brice Questionnaire | Perioperative/Periprocedural |
| Total dose(s) of intraoperative vasopressor(s) | phenylephrine (㎍) | Perioperative/Periprocedural |
| Total dose(s) of intraoperative vasopressor(s) | norepinephrine (㎍) | Perioperative/Periprocedural |