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Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation

NCT05864404 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-05-30

No results posted yet for this study

Summary

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.

Conditions

  • Patients With Atrial Fibrillation Undergoing Catheter Ablation

Interventions

DRUG

remimazolam-remifentanil

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.

DRUG

dexmedetomidine-remifentanil

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2024-10-09
Completion
2024-10-09

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864404 on ClinicalTrials.gov