Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059210) titled 'Comparison of recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Hiroshima Heart Center
Condition:
Condition - patients with atrial fibrillation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - The administration of propofol and fentanyl to maintain general anesthesia
Interventions/Control_2 - The administration of propofol and fentanyl to maintain general anesthesia
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients with atrial fibrillation scheduled for pulsed field ablation
Key exclusion criteria - Patients with hepatic dysfunction of Child-Pugh classification B or higher
Patients receiving renal replacement therapy
Severely obese patients (Body mass index 35 or higher)
Dementia patients
Patients who are allergic to anesthetics
Target Size - 62
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 27 Day
Date of IRB - 2025 Year 09 Month 16 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067631
Disclaimer: Curated by HT Syndication.
