Clinical trial NCT06013345: COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)
Official title: Conventional Vs. Optimised Periprocedural Analgosedation Vs. Total Intravenous Anaesthesia for Pulsed-field Ablation: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Analgosedation
Remimazolam
Atrial Fibrillation
Pulsed field ablation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study arms, analgosedation and TIVA protocols:

1. Conventional propofol analgosedation (arm P): current standard practice in most centres, a combination of short-acting benzodiazepine (midazolam) at the beginning, short-acting opioid (sufentanil in this study) and propofol boluses before and during the application of ablation pulses with unsecured airway
2. Optimised continuous intravenous analgosedation (arm R): ultrashort-acting benzodiazepine (remimazolam) and ketamine with unsecured airway
3. Total intravenous anaesthesia with secured airway (arm TIVA): continuous propofol infusion using target controlled infusion (TCI) and short acting opioid boluses - sufentanil
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events)
timeFrame: Procedure duration
Secondary outcomes:
measure: Total number of haemodynamic instability events (hypoxemia, hypotension, hypertension; defined above), each five minutes of a continuous instability counts as a new event, as well as an instability persisting despite an intervention
timeFrame: Procedure duration
measure: Total number of: a) hypoxemia events hypoxaemia <85% (more than 60s) b) hypotension events = systolic blood pressure (SBP) < 85 mmHg (more than 60s) c) hypertension event = SBP > 200 mmHg (more than 60s)
timeFrame: Procedure duration
measure: Total number of interventions a) jaw thrust b) nasopharyngeal airway administration c) LMA / orotracheal intubation d) increasing FiO2 (oxygen flow) e) hypotensive drugs administration f) vasoactive drugs administration (ephedrine, noradrenaline)
timeFrame: Procedure duration
measure: Total procedural time
timeFrame: Procedure duration
measure: Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure)
timeFrame: Procedure duration
measure: Procedural sedation quality
timeFrame: 12-24 hours after the procedure
measure: Difficult sedation score
timeFrame: Procedure duration
measure: Operator's satisfaction score
timeFrame: Procedure duration
measure: Total number of serious adverse events
timeFrame: From randomization until discharge
measure: carbon dioxide partial pressure after the procedure
timeFrame: blood sample taken after the procedure (up to 10 minutes)
measure: 28-day serious adverese events
timeFrame: discharge to the day 28
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady
Study officials:
References: