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Brain monitor may improve sedation safety for heart shock procedure

NCT ID NCT07569016

Symptom relief Sponsor: Istanbul University - Cerrahpasa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a brain activity monitor (BIS) to guide sedation during a procedure that shocks the heart back to normal rhythm leads to faster recovery and fewer side effects. About 60 adults with atrial fibrillation will be randomly assigned to receive sedation guided by the BIS monitor or by standard checks. The goal is to find the safest and most comfortable sedation approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Deep sedation Electric countershock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istanbul University-Cerrahpasa, Cardiology Institute

    RECRUITING

    Istanbul, Turkey (Türkiye)

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