search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Remimazolam
Propofol
Propofol
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Analgosedation, Remimazolam, Atrial Fibrillation, Pulsed field ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Arm P

    Arm R

    Arm TIVA (Total Intravenous Anesthesia)

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events)
    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 Outcome Measures

    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
    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)
    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)
    Total procedural time
    Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure)
    Procedural sedation quality
    PROcedural Sedation Assessment Survey - a previously validated form
    Difficult sedation score
    1-10 scale (10 = the worst), reported by an anaesthesiologist
    Operator's satisfaction score
    1-10 scale (10 = the worst), reported by the operating physician
    Total number of serious adverse events
    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
    partial pressure (kPa) of CO2 measured in an arterial blood sample
    28-day serious adverese events
    death, a condition related to the procedure requiring inpatient hospitalization

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Charles University, Czech Republic
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06013345
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Charles University, Czech Republic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    Analgosedation, Remimazolam, Atrial Fibrillation, Pulsed field ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Study arms, analgosedation and TIVA protocols: 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 Optimised continuous intravenous analgosedation (arm R): ultrashort-acting benzodiazepine (remimazolam) and ketamine with unsecured airway Total intravenous anaesthesia with secured airway (arm TIVA): continuous propofol infusion using target controlled infusion (TCI) and short acting opioid boluses - sufentanil
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm P
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Arm R
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Arm TIVA (Total Intravenous Anesthesia)
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Remimazolam
    Intervention Description
    analgosedation without secured airway
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    analgosedation with secured airway
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    TIVA with secured airway
    Primary Outcome Measure Information:
    Title
    Primary composite endpoint (rate of hypoxaemia, hypotension, or hypertension events)
    Description
    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
    Time Frame
    Procedure duration
    Secondary Outcome Measure Information:
    Title
    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
    Time Frame
    Procedure duration
    Title
    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)
    Time Frame
    Procedure duration
    Title
    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)
    Time Frame
    Procedure duration
    Title
    Total procedural time
    Time Frame
    Procedure duration
    Title
    Analgosedation depth by bispectral (BIS) monitoring: area under the curve of BIS index (measured every 3 minutes during the procedure)
    Time Frame
    Procedure duration
    Title
    Procedural sedation quality
    Description
    PROcedural Sedation Assessment Survey - a previously validated form
    Time Frame
    12-24 hours after the procedure
    Title
    Difficult sedation score
    Description
    1-10 scale (10 = the worst), reported by an anaesthesiologist
    Time Frame
    Procedure duration
    Title
    Operator's satisfaction score
    Description
    1-10 scale (10 = the worst), reported by the operating physician
    Time Frame
    Procedure duration
    Title
    Total number of serious adverse events
    Description
    death, cardiopulmonary resuscitation (chest compression or adrenaline administration), an emergency intubation or prolonged stay in intensive care unit
    Time Frame
    From randomization until discharge
    Title
    carbon dioxide partial pressure after the procedure
    Description
    partial pressure (kPa) of CO2 measured in an arterial blood sample
    Time Frame
    blood sample taken after the procedure (up to 10 minutes)
    Title
    28-day serious adverese events
    Description
    death, a condition related to the procedure requiring inpatient hospitalization
    Time Frame
    discharge to the day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marek Hozman, MD
    Phone
    +420 267 161 111
    Email
    marek.hozman@fnkv.cz

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs