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The primary purpose of this study was to investigate whether remimazolam administration for sedation had a positive effect on patients' satisfaction compared to dexmedetomidine administration in patients with atrial fibrillation undergoing catheter ablation.
Atrial fibrillation is a common arrhythmia in clinical practice. Catheter ablation can be used when the cause of atrial fibrillation is in the pulmonary veins. However, the procedure takes 2 to 4 hours, and patients complain of considerable discomfort. Remimazolam has the advantage of having no drug interaction with CYP3A4 and shorter elimination half-life, duration of action, and shorter recovery time than midazolam, a previously used drug. In addition, compared to dexmedetomidine, side effects such as bradycardia and hypotension are expected to be less. In addition, even if unexpected deep sedation is induced, complete reversal using flumazenil is possible, so the risk of re-sedation could be low.
In other words, when remimazolam is used instead of a drug previously used as a sedative in atrial fibrillation patients undergoing catheter ablation, effects such as rapid action and recovery, reduced complications, improved safety, and improved patient satisfaction can be expected. Therefore, this study was designed to confirm the hypothesis that administration of remimazolam would improve satisfaction in patients undergoing catheter ablation compared to dexmedetomidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam-remifentanil (RR group) | Experimental |
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| dexmedetomidine-remifentanil (DR group) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam-remifentanil | Drug | In the case of remimazolam, the bolus is prepared in a 30cc syringe by mixing 0.075mg/kg and normal saline to make a total of 25mL. Inject the bolus at a rate of 150 cc/h, and measure the sedation depth every 2 to 3 minutes, stopping the infusion when the target sedation depth (RASS -1 to -2 points) is reached. Remimazolam is then infused at 0.5 to 1 mg/kg/hr to maintain the target depth of sedation until the end of the procedure. Remifentanil was infused at a rate of 1.2-7.2 mcg/kg/h. |
| Measure | Description | Time Frame |
|---|---|---|
| The satisfaction levels of the patients | The satisfaction levels of the patients was assessed with a 5-point numerical scale (0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied). | Immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Soh | Contact | 82-2-2228-8512 | yeonchoo@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Recruiting | Seoul | South Korea |
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| dexmedetomidine-remifentanil | Drug | In the case of dexmedetomidine, the bolus is prepared in a 30cc syringe by mixing 1.0mcg/kg and normal saline to make a total of 25mL. Inject the bolus at a rate of 150 cc/h, and measure the sedation depth every 2 to 3 minutes, stopping the infusion when the target sedation depth (RASS -1 to -2 points) is reached. Dexmedetomidine is then infused at 0.4 to 0.8 mcg/kg/h to maintain the target depth of sedation until the end of the procedure. Remifentanil was infused at a rate of 1.2-7.2 mcg/kg/h. |
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