Atrial fibrillation
Conditions
Interventions
Deep Sedation Group:Continuous titrated infusion of propofol for anesthesia maintenance throughout the CA procedure, with infusion of remifentanil or fentanyl
Conscious Sedation Group:Intravenous administration of fentanyl or remifentanil
Sponsors
First Affiliated Hosptial of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old (including cut-off value, calculated on the day of signing informed consent), gender is not limited; (2) Study participants with confirmed atrial fibrillation (refer to the Chinese Guidelines for the Diagnosis and Treatment of Atrial Fibrillation 2023), including paroxysmal atrial fibrillation, persistent atrial fibrillation, and persistent atrial fibrillation; (3) Meet the indications for catheter ablation of atrial fibrillation and receive the first catheter ablation treatment; (4) Research participants can follow the regular visits arranged by the investigators, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Received catheter ablation or atrial septal defect repair surgery for AF before enrollment; (2) Left atrial diameter (LAD) >=55 mm; or left atrial thrombosis; (3) study participants with an eGFR 35 kg/m^2; (8) Has a contraindication to procedural sedation or refuses to participate in this study; (9) Patients with congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh grade B-C grade), severe coagulation dysfunction (international normalized ratio (INR)>1.5 or prolonged partially activated prothrombin time (APTT) >=10 seconds, or prolonged plasma prothrombin time (PT) >=3 seconds, or fibrinogen (Fib) <=1.5 g/L) or active bleeding; (10) Pregnant, lactating women or those who have a pregnancy plan during the study, and those who have positive pregnancy test results during the screening period; (11) Life expectancy<12 months; (12) Those who have participated in other clinical drug trials within 3 months before enrollment; (13) Study participants with known allergies to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.; (14) According to the judgment of the investigator, it is considered inappropriate to participate in this clinical study (such as not meeting the most beneficial treatment of the research participant, the compliance of the research participant, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The freedom from documented atrial arrhythmia after blanking- period;The incidence of intraprocedural severe decrease in blood oxygenation (decrease in fingertip oxygen saturation to less than 90% or a >10% decrease in fingertip oxygen saturation from baseline) ;The incidence of apnea, respiratory depression, need for ventilator-assisted ventilation, need for respiratory stimulant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of patients' intraprocedural experiences;Ablation Operator/Nurse/CS Surgical Satisfaction;Procedure, fluoroscopy, ablation time;The dosage of painkillers;Rate of acceptance of re-catheter ablation;The times of remapping;The incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway ; | — |
Countries
China
Contacts
Public ContactYunlong Xia
First Affiliated Hosptial of Dalian Medical University
Outcome results
None listed