search
Back to results

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

Primary Purpose

Patients With Atrial Fibrillation Undergoing Catheter Ablation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remimazolam-remifentanil
dexmedetomidine-remifentanil
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patients With Atrial Fibrillation Undergoing Catheter Ablation

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

remimazolam-remifentanil (RR group)

dexmedetomidine-remifentanil (DR group)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 25, 2023
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT05864404
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
October 9, 2024 (Anticipated)
Study Completion Date
October 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Atrial Fibrillation Undergoing Catheter Ablation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
remimazolam-remifentanil (RR group)
Arm Type
Experimental
Arm Title
dexmedetomidine-remifentanil (DR group)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
remimazolam-remifentanil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine-remifentanil
Intervention Description
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.
Primary Outcome Measure Information:
Title
The satisfaction levels of the patients
Description
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).
Time Frame
Immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Soh
Phone
82-2-2228-8512
Email
yeonchoo@yuhs.ac
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Soh
Phone
82-2-2228-8512
Email
yeonchoo@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs