BridgeMD
Compares treatment options for Atrial Fibrillation
Official title BIS-Guided Sedation Versus Standard Clinical Sedation During Elective Electrical Cardioversion for Atrial Fibrillation
ClinicalTrials.gov ID: NCT07569016
What this study is testing
What is BIS-guided propofol sedation?
BIS-guided propofol sedation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Electrical cardioversion (ECV) is a standard procedure used to restore normal heart rhythm in patients with atrial fibrillation (AF) by delivering a brief electrical shock to the heart. Because the procedure is painful and distressing, patients receive sedation - a controlled state of reduced consciousness - using short-acting intravenous medications.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Documented atrial fibrillation with indication for elective electrical cardioversion
- American Society of Anesthesiologists (ASA) physical status class I, II, or III
- Left ventricular ejection fraction ≥30% on echocardiography
- Adequate anticoagulation: INR ≥2.0, OR ≥3 weeks of therapeutic anticoagulation, OR absence of left atrial thrombus confirmed by transesophageal...
You likely can't join if
- Known allergy or contraindication to propofol or fentanyl, or their excipients (soy, egg)
- Hemodynamic instability (systolic blood pressure \<90 mmHg or symptomatic hypotension)
- Decompensated heart failure (NYHA functional class IV)
- Severe obstructive sleep apnea requiring CPAP or BiPAP therapy
- Anticipated difficult airway (modified Mallampati classification class III or IV)
- Baseline oxygen saturation \<94% or active chronic obstructive pulmonary disease
See the full eligibility criteria
- Age ≥18 years
- Documented atrial fibrillation with indication for elective electrical cardioversion
- American Society of Anesthesiologists (ASA) physical status class I, II, or III
- Left ventricular ejection fraction ≥30% on echocardiography
- Adequate anticoagulation: INR ≥2.0, OR ≥3 weeks of therapeutic anticoagulation, OR absence of left atrial thrombus confirmed by transesophageal echocardiography
- Ability and willingness to provide written informed consent
- Known allergy or contraindication to propofol or fentanyl, or their excipients (soy, egg)
- Hemodynamic instability (systolic blood pressure \<90 mmHg or symptomatic hypotension)
- Decompensated heart failure (NYHA functional class IV)
- Severe obstructive sleep apnea requiring CPAP or BiPAP therapy
- Anticipated difficult airway (modified Mallampati classification class III or IV)
- Baseline oxygen saturation \<94% or active chronic obstructive pulmonary disease
- Severe hepatic impairment (transaminases \>3× upper limit of normal) or severe renal impairment (eGFR \<30 mL/min/1.73m²)
- Active psychiatric illness or cognitive impairment precluding questionnaire completion
- Pregnancy or breastfeeding
- Alcohol or substance use within the preceding 24 hours
- Prior participation in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Turkey (Türkiye)
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.