[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634565":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":66,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Beijing Anzhen Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"conscious sedation group","EXPERIMENTAL","A conscious sedation regimen based on remimazolam combined with fentanyl, plus lidocaine for antitussive therapy, administered by electrophysiologists.",[13],"Procedure: conscious sedation",{"label":15,"type":16,"description":17,"interventionNames":18},"General anesthesia group","ACTIVE_COMPARATOR","The general anesthesia group adopted a standardized general anesthesia process of remimazolam + sufentanil + rocuronium for anesthesia induction, and remimazolam + remifentanil for anesthesia maintenance.",[19],"Procedure: General Anesthesia (control group)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","conscious sedation","Medications: Remimazolam toluenesulfonate injection (25 mg) + Fentanyl citrate injection (0.1 mg) + Lidocaine (100 mg).\n\nAdministration method:\n\nRemimazolam: 2 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 1 mg\u002FmL. The target Bispectral Index (BIS) is 60-80, and the infusion rate of remimazolam is adjusted according to the BIS and patient responses.\n\nFentanyl citrate: 5 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 0.01 mg\u002FmL. Dose reduction and slower injection rate are required for patients with hepatic\u002Frenal insufficiency, obesity, or elderly\u002Fweak conditions.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"General Anesthesia (control group)","After femoral vein puncture, anesthesia induction was performed with remimazolam (0.2-0.3 mg\u002Fkg), sufentanil (0.3-0.4 μg\u002Fkg) and rocuronium (0.6 mg\u002Fkg) following standard monitoring and preoxygenation. A laryngeal mask airway was inserted upon loss of consciousness and adequate muscle relaxation, with lung-protective mechanical ventilation applied at tidal volume 6-8 mL\u002Fkg, respiratory rate 10-14 breaths\u002Fmin, I:E 1:2, FiO₂ 60% and fresh gas flow 2-3 L\u002Fmin to maintain PaCO₂ at 35-45 cmH₂O. Anesthesia was maintained with continuous intravenous ciprofol (0.4-1 mg\u002Fkg\u002Fh) and remifentanil (0.1-0.2 μg\u002Fkg\u002Fmin) to keep BIS 60-80 and MAP \\>70 mmHg, with vasoactive agents as needed. Anesthetics were discontinued before surgery end; the laryngeal mask airway was removed after the patient regained consciousness with satisfactory spontaneous breathing, and antagonistic drugs were used if necessary.",[15],[32],"general anesthesia",[34],{"name":35,"affiliation":5,"role":36},"Ning Zhou","STUDY_CHAIR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Ning Zhou, MD and PhD","CONTACT","86+13910526308","zn075@163.com",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"SiTong Li, MD","86+17888810926","moonli1996@163.com",[48],{"facility":5,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Beijing","Beijing Municipality","100029","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61,63],{"name":62,"role":40,"phone":41,"phoneExt":26,"email":46},"Sitong Li, MD",{"name":64,"role":65,"phone":26,"phoneExt":26,"email":26},"Wanting Qin, MD","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"NingZhou","Professor","100634565","safety-and-efficacy-of-conscious-sedation-versus-general-anesthesia-in-pulsed-field-ablation-for-paroxysmal-atrial-fibrillation-100634565",false,"NCT07541339","Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation","Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial","SEDATE-PFA","Inclusion Criteria:\n\n* Aged 18 to 80 years\n* Diagnosed with paroxysmal atrial fibrillation\n* No prior history of catheter ablation for atrial fibrillation\u002Fatrial flutter\n* Scheduled to undergo pulsed-field ablation\n* Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments\n\nExclusion Criteria:\n\n* Obstructive sleep apnea-hypopnea syndrome (OSAHS)\n* Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases\n* Body mass index (BMI) \\>30 kg\u002Fm² or \\\u003C20 kg\u002Fm²\n* Preoperative pulse oxygen saturation (SpO₂) \\\u003C93%\n* Anticipated difficult airway\n* Intolerance to general anesthesia (American Society of Anesthesiologists \\[ASA\\] physical status ≥Ⅳ)\n* Current left ventricular ejection fraction (LVEF) ≤40% or New York Heart Association (NYHA) functional class Ⅲ-Ⅳ\n* Acute coronary syndrome within 3 months\n* Within 3 months after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or other cardiac\u002Fvascular surgeries\n* Moderate\u002Fsevere stenosis or severe regurgitation of aortic or mitral valve\n* Acute cerebrovascular disease within 1 month\n* Severe hepatic insufficiency (Child-Pugh Class C)\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m² or on dialysis\n* History of chronic heavy alcohol consumption\n* History of substance abuse\n* Hypersensitivity to any medications used in the study protocol\n* Pregnancy or lactation\n* Concurrent participation in other interventional clinical trials\n* Other conditions deemed unsuitable for study participation by the investigators","ALL","18 Years","80 Years",{"count":81,"type":82},224,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:\n\n1. Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia?\n2. What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.\n\nParticipants will:\n\n1. Receive the assigned anesthetic strategy combined with standardized PFA procedure\n2. Complete intraoperative vital sign and related index monitoring\n3. Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording",[88],"Atrial Fibrillation (Paroxysmal)",[90,91,92,93,94,95],"Paroxysmal atrial fibrillation","Pulsed-field ablation","Conscious sedation","General anesthesia","Efficacy","Safety","NOT_YET_RECRUITING","2026-04-14",{"date":99,"type":100},"2026-04-21","ACTUAL",{"date":102,"type":82},"2026-04-01",{"date":104,"type":82},"2027-03-01",{"name":5,"class":6},1]