Atrial Fibrillation
Conditions
Keywords
Analgosedation, Remimazolam, Atrial Fibrillation, Pulsed field ablation
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.
Interventions
DRUGRemimazolam
analgosedation without secured airway
DRUGPropofol
analgosedation with secured airway
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events) | Procedure duration | Composite endpoint consisting of the rate of (1) hypoxaemia events requiring intervention, (2) hypotension events requiring intervention or leading to the procedure interruption, or (3) hypertension events requiring intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Procedure duration | — |
| 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) | Procedure duration | — |
| Total procedural time | Procedure duration | — |
| Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure) | Procedure duration | — |
| Procedural sedation quality | 12-24 hours after the procedure | PROcedural Sedation Assessment Survey - a previously validated form |
| 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 | Procedure duration | — |
| Operator's satisfaction score | Procedure duration | 1-10 scale (10 = the worst), reported by the operating physician |
| Total number of serious adverse events | From randomization until discharge | death, cardiopulmonary resuscitation (chest compression or adrenaline administration), an emergency intubation or prolonged stay in intensive care unit |
| carbon dioxide partial pressure after the procedure | blood sample taken after the procedure (up to 10 minutes) | partial pressure (kPa) of CO2 measured in an arterial blood sample |
| 28-day serious adverese events | discharge to the day 28 | death, a condition related to the procedure requiring inpatient hospitalization |
| Difficult sedation score | Procedure duration | 1-10 scale (10 = the worst), reported by an anaesthesiologist |
Countries
Czechia
Outcome results
None listed