Clinical trial NCT05864404: Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation
Official title: Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Atrial Fibrillation Undergoing Catheter Ablation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age 20-79 years, gender not limited
* Patients undergoing catheter ablation for atrial fibrillation who require monitored anesthetic care (MAC).
* Patients with an American Society of Anesthesiologists (ASA) physical status classification 1,2,3.

Exclusion Criteria:

* Patients with an American Society of Anesthesiologists (ASA) physical status classification \>3.
* Patients with a history of psychiatric disorders
* Patients with myocardial infarction or stroke within the past year
* Patients with a history of major vascular surgery or cardiac surgery within the past year
* Patients with reduced liver function, chronic kidney disease (stage 3 or higher)
* Patients diagnosed with heart failure with a left ventricular ejection fraction \<40%
* Patients who need vasopressor or oxygen therapy due to unstable vital signs before procedure.
* Patients with fever (\>38°) or severe uncontrolled high blood pressure
* Patients with a history of drug hypersensitivity during previous anesthesia
* Patients who are unable to communicate and have cognitive impairment
* Patients with a history of drug or alcohol addiction
* Patients with a history of obstructive sleep apnea

Primary outcomes:
measure: The satisfaction levels of the patients
timeFrame: Immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References: