COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)

Charles University, Czech Republic

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Remimazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06013345

Coopertaive-PFA

Details and patient eligibility

About

A prospective single blinded (subject blinded) 1:1:1 randomised control trial with three parallel arms testing superiority of analgosedation regimen based on remimazolam and total intravenous anesthesia over propofol based analgosedation. The primary composite endpoint consists of hypoxaemia, hypotension, or hypertension requiring intervention.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atrial fibrillation (AF) (paroxysmal, persistent or long standing persistent) with indication for catheter ablation
• Age above 18 years
• Capacity to give informed consent

Exclusion criteria

• Heart failure (NYHA III-IV), irrespective of left ventricular ejection fraction
• Left ventricular ejection fraction < 20%
• Significant valvulopathy (moderate or severe aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, moderate and severe mitral stenosis, severe tricuspid regurgitation)
• Obstructive sleep apnoea syndrome (AHI >30)
• Low oxygen saturation (<93%) at baseline
• High aspiration risk (hiatal hernia, gastroesophageal reflux disease on chronic pharmacotherapy)
• Hypersensitivity to the study drugs
• Chronic kidney disease (stage 4 and 5 of CKD), liver cirrhosis
• Anticipated difficult airways
• ASA (American Society of Anaesthesiologists) score > 4
• Schizophrenia
• Epilepsy
• Other individual contraindications (will be reported in detail)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 3 patient groups

Arm P

Active Comparator group

Description:

Patients in arm P will be administered 2-3 mg midazolam IV before the beginning of the procedure, 5-10 mcg sufentanil IV and a loading dose of propofol 0,8-1,0 mg/kg in 2-5 minutes before the start of the ablation phase. During the procedure, boluses of 0,5 mg/kg propofol will be repeated as needed, in case of inappropriate analgosedation, boluses of midazolam and/or sufentanil can also 0be repeated.

Treatment:

Drug: Propofol

Drug: Propofol

Arm R

Experimental group

Description:

Patients in arm R will be administered 2,5 mg loading dose of remimazolam followed by continuous infusion at 0,5 mg/h/kg of ideal body weight (IBW, calculated using the Miller formula) and a dose of ketamine 1 mg/kg IBW 2-5 minutes before the beginning of the ablation phase. In case of inadequate sedation depth, a bolus of 2,5 mg remimazolam can be repeated as needed. If the patient shows signs of pain or discomfort, a single dose of ketamine - 0,5 mg/kg IBW - will be administered, followed by a bolus of 5-10 mcg sufentanil if needed. The continuous infusion will be terminated as the last ablation pulses are delivered.

Treatment:

Drug: Remimazolam

Arm TIVA (Total Intravenous Anesthesia)

Active Comparator group

Description:

Patients randomised in arm TIVA will be administered light analgosedation with spontaneous ventilation for the first part of the procedure. The analgosedation will be induced and maintained with bolus of 5 mcg sufentanil IV and propofol infusion dosed by TCI system (the target plasma concentration for propofol 1-2 mcg/ml). Before the beginning of the ablation phase, general anesthesia will be induced with one bolus of 5-10 mcg sufentanil (the TCI target 3-7 mcg/ml for induction and 3-5 mcg/ml for the rest of the procedure), and a bolus of rocuronium 0,2-0,4 mg/kg IBW. Then, the airways will be secured with a laryngeal mask (LMA), the patient ventilated (0,4 - 0,45 FiO2, the target EtCO2 30 - 45 mmHg). After the last ablation pulse is delivered, infusion of propofol will be ceased and LMA extracted at the return of consciousness, muscle strength and sufficient spontaneous ventilation. If residual muscle relaxation occurs, sugammadex will be administered.

Treatment:

Drug: Propofol

Drug: Propofol