Atrial FibrillationBIS-ECV-RCTNCT07569016
BIS-Guided Sedation Versus Standard Clinical Sedation During Elective Electrical Cardioversion for Atrial Fibrillation
A study testing BIS-guided propofol sedation and Clinical-guided propofol sedation in people with Atrial Fibrillation and Electric Countershock, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Electric Countershock, Deep Sedation
- What is being tested?
- BIS-guided propofol sedation and Clinical-guided propofol sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa, Cardiology Institute
Istanbul
AYLA ESIN, MD, 00905326343959, ayla.esin@iuc.edu.tr
Kerem Erkalp, Professor MD
About this study
Official title: Bispectral Index-Guided Sedation Versus Standard Clinical Assessment-Guided Sedation During Elective Electrical Cardioversion for Atrial Fibrillation: A Prospective, Single-Center, Randomized Controlled, Assessor-Blinded Trial
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. However, the optimal depth of sedation for ECV has not been well defined: too deep may cause breathing problems and low blood pressure, while too light may result in pain, awareness, or patient movement during the shock.
Bispectral index (BIS) monitoring is a non-invasive technology that continuously measures brain activity using an EEG sensor placed on the forehead, generating a numerical score from 0 (no brain activity) to 100 (fully awake). BIS scores between 61 and 80 correspond to moderate sedation, which preliminary observations suggest may be sufficient for ECV without the risks associated with deeper sedation.
Read more
This randomized controlled trial will compare two approaches to sedation monitoring during elective ECV for AF:
- Group 1 (BIS Group): Sedation is guided by BIS monitoring, targeting a score of 61-80.
- Group 2 (Control Group): Sedation is guided by standard clinical assessment (loss of response to verbal commands and eyelash reflex), with BIS recorded but not visible to the treating team.
Both groups will receive the same medications (propofol and fentanyl). The primary outcome is how quickly patients recover after the procedure, measured by the Modified Aldrete Score - a standard clinical recovery assessment tool. Secondary outcomes include patient and physician satisfaction, procedural pain, risk of awareness during the procedure, cardioversion success rate, hemodynamic stability, and complication rates.
The trial will enroll 60 adult patients at Istanbul University-Cerrahpasa Cardiology Institute. Findings are expected to provide evidence-based guidance for standardizing sedation protocols during ECV.
Read the detailed description
Background:
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia. Elective electrical cardioversion (ECV) is a widely used rhythm control strategy. Procedural sedation is a critical component of ECV; however, the optimal monitoring method and depth of sedation remain undefined. Excessive sedation risks respiratory depression and hemodynamic instability, particularly in patients with structural heart disease, while inadequate sedation may result in patient movement, pain, and procedural awareness.
Bispectral index (BIS) monitoring offers objective, real-time quantification of sedation depth. Preliminary clinical observation at our center suggests that BIS 61-80 provides adequate procedural conditions for ECV with propofol-fentanyl sedation, while deeper sedation (BIS <60) is associated with increased respiratory depression without additional procedural benefit.
- Conditions
- Atrial Fibrillation, Electric Countershock, Deep Sedation
- Being tested
- BIS-guided propofol sedation, Clinical-guided propofol sedation
- Keywords
- atrial fibrillation, Electric Countershock, sedation, bispectral index, propofol, anesthesia recovery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-guided propofol sedationDrug
IV propofol 0.5-1 mg/kg titrated to BIS 61-80, preceded by IV fentanyl 0.5-1 µg/kg. Additional propofol 0.25-0.5 mg/kg boluses as needed for repeat shocks within target range.
Clinical-guided propofol sedationDrug
IV propofol 0.5-1 mg/kg titrated to clinical endpoints, preceded by IV fentanyl 0.5-1 µg/kg. BIS recording passive (blinded to operator).
| Study group | Role | What they receive |
|---|---|---|
| BIS-Guided Sedation (BIS Group) | Experimental | Patients in this group receive sedation with intravenous fentanyl (0.5-1 µg/kg) followed by titrated propofol (0.5-1 mg/kg) guided by continuous BIS monitoring, targeting a BIS range of 61-80. Cardioversion is initiated once the target BIS range is achieved and clinical endpoints (loss of verbal contact, loss of eyelash reflex) are confirmed. Receives: Drug: BIS-guided propofol sedation |
| Standard Clinical Sedation (Control Group) | Active comparator | Patients in this group receive sedation with intravenous fentanyl (0.5-1 µg/kg) followed by titrated propofol (0.5-1 mg/kg) guided by standard clinical assessment (loss of verbal contact, loss of eyelash reflex). BIS monitoring is applied but the monitor screen is physically concealed from the treating team. BIS values are recorded for analysis only. Receives: Drug: Clinical-guided propofol sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recovery (Modified Aldrete Score ≥9)
Time in minutes from sedation induction (first propofol dose) to achievement of Modified Aldrete Score ≥9, assessed by an independent, blinded anesthesiologist. The Modified Aldrete Score evaluates activity, respiration, circulation, consciousness, and oxygen saturation (0-2 points each; maximum 10). Score ≥9 indicates readiness for discharge from monitored care.
Measured: From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.
Secondary outcomes (7)
Patient Satisfaction
Patient-reported global satisfaction with the procedure assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied), administered by the blinded assessor after Modified Aldrete Score ≥9 is achieved.
Measured: Within 60 minutes post-procedure.
Physician Satisfaction
Treating cardiologist's global satisfaction with sedation conditions assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied), recorded immediately after the procedure.
Measured: Immediately post-procedure (within 5 minutes of ECV completion).
Procedural Pain
Patient-reported pain intensity during the procedure assessed using the Numeric Rating Scale-11 (NRS-11; 0 = no pain, 10 = worst imaginable pain), administered after recovery.
Measured: Within 60 minutes post-procedure (after Modified Aldrete Score ≥9).
Cardioversion Success Rate
Proportion of patients achieving restoration of sinus rhythm confirmed by 12-lead ECG within 1 hour of the procedure.
Measured: Within 1 hour post-ECV.
Incidence of sedation related complications
Proportion of patients experiencing any of the following: hypotension (systolic BP <90 mmHg), bradycardia (HR <50 bpm), oxygen desaturation (SpO₂ <90%), apnea, laryngospasm, or procedurally significant arrhythmia. Recorded as a composite binary outcome (yes/no).
Measured: From sedation induction to 60 minutes post-procedure.
Total Anesthetic Drug Consumption
Total dose (mg/kg) of propofol and fentanyl (µg/kg) administered during the procedure.
Measured: During procedure
Number of Cardioversion Shocks and Total Energy Delivered
Total number of synchronized shocks delivered and cumulative energy (Joules) used per patient.
Measured: During the ECV procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start13 Apr 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYLA ESİN, Istanbul University - Cerrahpasa
- Investigators
- Kerem Erkalp, Professor Dr, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569016
- Sponsor's protocol ID
- 20260404
- Acronym
- BIS-ECV-RCT
- Status last verified
- May 2026
- First submitted
- 12 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. Aggregate de-identified results will be reported in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index-Guided Sedation Versus Standard Clinical Assessment-Guided Sedation During Elective Electrical Cardioversion for Atrial Fibrillation: A Prospective, Single-Center, Randomized Controlled, Assessor-Blinded Trial
- ClinicalTrials.gov ID
- NCT07569016
- Acronym / sponsor ID
- BIS-ECV-RCT / 20260404
- Conditions
- Atrial Fibrillation, Electric Countershock, Deep Sedation
- Keywords
- atrial fibrillation, Electric Countershock, sedation, bispectral index, propofol, anesthesia recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, the optimal depth of sedation for ECV has not been well defined: too deep may cause breathing problems and low blood pressure, while too light may result in pain, awareness, or patient movement during the shock.
Bispectral index (BIS) monitoring is a non-invasive technology that continuously measures brain activity using an EEG sensor placed on the forehead, generating a numerical score from 0 (no brain activity) to 100 (fully awake). BIS scores between 61 and 80 correspond to moderate sedation, which preliminary observations suggest may be sufficient for ECV without the risks associated with deeper sedation.
This randomized controlled trial will compare two approaches to sedation monitoring during elective ECV for AF:
- Group 1 (BIS Group): Sedation is guided by BIS monitoring, targeting a score of 61-80.
- Group 2 (Control Group): Sedation is guided by standard clinical assessment (loss of response to verbal commands and eyelash reflex), with BIS recorded but not visible to the treating team.
Both groups will receive the same medications (propofol and fentanyl). The primary outcome is how quickly patients recover after the procedure, measured by the Modified Aldrete Score - a standard clinical recovery assessment tool. Secondary outcomes include patient and physician satisfaction, procedural pain, risk of awareness during the procedure, cardioversion success rate, hemodynamic stability, and complication rates.
The trial will enroll 60 adult patients at Istanbul University-Cerrahpasa Cardiology Institute. Findings are expected to provide evidence-based guidance for standardizing sedation protocols during ECV.
Detailed description
Background:
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia. Elective electrical cardioversion (ECV) is a widely used rhythm control strategy. Procedural sedation is a critical component of ECV; however, the optimal monitoring method and depth of sedation remain undefined. Excessive sedation risks respiratory depression and hemodynamic instability, particularly in patients with structural heart disease, while inadequate sedation may result in patient movement, pain, and procedural awareness.
Bispectral index (BIS) monitoring offers objective, real-time quantification of sedation depth. Preliminary clinical observation at our center suggests that BIS 61-80 provides adequate procedural conditions for ECV with propofol-fentanyl sedation, while deeper sedation (BIS <60) is associated with increased respiratory depression without additional procedural benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS-Guided Sedation (BIS Group) | Experimental | Drug: BIS-guided propofol sedationPatients in this group receive sedation with intravenous fentanyl (0.5-1 µg/kg) followed by titrated propofol (0.5-1 mg/kg) guided by continuous BIS monitoring, targeting a BIS range of 61-80. Cardioversion is initiated once the target BIS range is achieved and clinical endpoints (loss of verbal contact, loss of eyelash reflex) are confirmed. |
| Standard Clinical Sedation (Control Group) | Active comparator | Drug: Clinical-guided propofol sedationPatients in this group receive sedation with intravenous fentanyl (0.5-1 µg/kg) followed by titrated propofol (0.5-1 mg/kg) guided by standard clinical assessment (loss of verbal contact, loss of eyelash reflex). BIS monitoring is applied but the monitor screen is physically concealed from the treating team. BIS values are recorded for analysis only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS-guided propofol sedationIV propofol 0.5-1 mg/kg titrated to BIS 61-80, preceded by IV fentanyl 0.5-1 µg/kg. Additional propofol 0.25-0.5 mg/kg boluses as needed for repeat shocks within target range. | Drug | BIS-Guided Sedation (BIS Group) |
| Clinical-guided propofol sedationIV propofol 0.5-1 mg/kg titrated to clinical endpoints, preceded by IV fentanyl 0.5-1 µg/kg. BIS recording passive (blinded to operator). | Drug | Standard Clinical Sedation (Control Group) |
Primary outcome
Time to Recovery (Modified Aldrete Score ≥9)
Time frame: From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.
Time in minutes from sedation induction (first propofol dose) to achievement of Modified Aldrete Score ≥9, assessed by an independent, blinded anesthesiologist. The Modified Aldrete Score evaluates activity, respiration, circulation, consciousness, and oxygen saturation (0-2 points each; maximum 10). Score ≥9 indicates readiness for discharge from monitored care.
7 secondary outcomes
Patient Satisfaction
Time frame: Within 60 minutes post-procedure.
Physician Satisfaction
Time frame: Immediately post-procedure (within 5 minutes of ECV completion).
Procedural Pain
Time frame: Within 60 minutes post-procedure (after Modified Aldrete Score ≥9).
Cardioversion Success Rate
Time frame: Within 1 hour post-ECV.
Incidence of sedation related complications
Time frame: From sedation induction to 60 minutes post-procedure.
Total Anesthetic Drug Consumption
Time frame: During procedure
Number of Cardioversion Shocks and Total Energy Delivered
Time frame: During the ECV procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Aggregate de-identified results will be reported in peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerem Erkalp, Professor Dr principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS-guided propofol sedation and Clinical-guided propofol sedation in people with Atrial Fibrillation and Electric Countershock, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYLA ESIN (+905326343959, ayla.esin@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recovery (Modified Aldrete Score ≥9) (time frame: From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.