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Deep SedationBIS-ERCPNCT07922291

Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography

A study testing BIS-Guided Propofol Titration and Standard Clinical Propofol Titration in people with Deep Sedation and Endoscopic Retrograde Cholangiopancreatography, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Endoscopic retrograde cholangiopancreatography (ERCP) requires deep sedation, and propofol is commonly used because of its rapid onset and recovery, but it has a narrow therapeutic window, especially in elderly patients. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
BIS-Guided Propofol Titration and Standard Clinical Propofol Titration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
Nov 2026to Apr 2027
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 65 years or older
  • American Society of Anesthesiologists (ASA) physical status III
  • Scheduled for endoscopic retrograde cholangiopancreatography (ERCP) under sedation
  • Written informed consent obtained from the patient or legal guardian

Who cannot join

  • Refusal to participate or to sign the informed consent form
  • Known allergy or hypersensitivity to propofol, midazolam, fentanyl, or to egg or soy components
  • Advanced dementia, Alzheimer's disease, prior major cerebrovascular event (stroke), severe cognitive dysfunction or active neurological disease that may affect bispectral index (BIS) measurements
  • Local infection, wound, burn or anatomical deformity of the forehead preventing proper placement of BIS electrodes
  • ASA IV or higher, hemodynamic instability (shock) or need for active resuscitation before the procedure
  • Severe hearing or speech impairment or psychiatric disease preventing assessment with clinical recovery scales

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

  • University of Health Sciences, Van Training and Research Hospital

    Van

    Ömer Türk, MD, +90 506 979 41 95, omer_turk@hotmail.com

    Ömer Türk, MD

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Bispectral Index (BIS) Monitoring on Postoperative Recovery Profile and Complications in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) Under Deep Sedation: A Randomized Controlled Trial

Endoscopic retrograde cholangiopancreatography (ERCP) requires deep sedation, and propofol is commonly used because of its rapid onset and recovery, but it has a narrow therapeutic window, especially in elderly patients. Bispectral index (BIS) monitoring provides an objective, electroencephalography (EEG)-based measure of sedation depth. This prospective, randomized, single-blind study compares BIS-guided titration of propofol infusion (target BIS 40-60) with standard clinical titration in elderly patients (65 years and older, American Society of Anesthesiologists (ASA) physical status III) undergoing ERCP, with respect to total anesthetic consumption, recovery time, hemodynamic and respiratory complications, and endoscopist satisfaction.

Read the detailed description

Patients aged 65 years and older, American Society of Anesthesiologists (ASA) physical status III, scheduled for endoscopic retrograde cholangiopancreatography (ERCP) under deep sedation will be randomized 1:1 using sealed envelopes to a bispectral index (BIS)-guided group or a standard care group. All patients receive standardized induction with intravenous (IV) midazolam 0.01 mg/kg, fentanyl 25 mcg and propofol 0.5 mg/kg, followed by a propofol infusion of 50-150 mcg/kg/min.

In the BIS group, the infusion rate is titrated to maintain BIS between 40 and 60, with additional low-dose propofol boluses when needed. In the standard group, BIS electrodes are attached and values are recorded blindly, but the monitor screen is hidden from the anesthesia team; the infusion rate is titrated according to heart rate, blood pressure, peripheral oxygen saturation (SpO2) and clinical signs (patient movement, gagging, swallowing).

ERCP is performed by a single experienced gastroenterologist blinded to group allocation. Heart rate, mean arterial pressure and SpO2 are recorded before and after induction, at 5, 10 and 15 minutes and at the end of the procedure. Recovery is assessed in the post-anesthesia care unit (PACU) using the Modified Aldrete Score.

Being tested
BIS-Guided Propofol Titration, Standard Clinical Propofol Titration
Keywords
bispectral index, propofol, ERCP, sedation depth monitoring, elderly, geriatric anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIS-Guided Propofol TitrationDevice

    After standardized induction (midazolam 0.01 mg/kg, fentanyl 25 mcg, propofol 0.5 mg/kg IV), the propofol infusion (50-150 mcg/kg/min) is titrated according to real-time bispectral index (BIS) values to maintain a target BIS of 40-60, with additional low-dose propofol boluses when needed.

  • Standard Clinical Propofol TitrationOther

    After the same standardized induction, the propofol infusion (50-150 mcg/kg/min) is titrated according to standard monitoring (heart rate, blood pressure, SpO2) and clinical signs (movement, gagging, swallowing). BIS electrodes are attached and values are recorded, but the BIS screen is hidden from the anesthesia team.

Study groups in NCT07922291
Study groupRoleWhat they receive
BIS-Guided SedationExperimentalPropofol infusion during ERCP is titrated to a target BIS of 40-60 using real-time bispectral index monitoring.
Receives: Device: BIS-Guided Propofol Titration
Standard Clinical SedationActive comparatorPropofol infusion during ERCP is titrated according to standard monitoring and clinical signs; BIS values are recorded but hidden from the anesthesia team.
Receives: Other: Standard Clinical Propofol Titration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Propofol Consumption

    Total amount of propofol (mg) administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure, including induction, infusion and additional boluses.

    Measured: From induction of sedation to the end of the ERCP procedure

Secondary outcomes (8)

  1. Gastroenterologist Satisfaction

    Procedural comfort and satisfaction rated by the gastroenterologist, who is blinded to group allocation, on a 5-point Likert scale (1 = very poor, 5 = very good).

    Measured: Immediately after the end of the ERCP procedure

  2. Heart Rate

    Heart rate (beats per minute) measured by standard electrocardiographic monitoring.

    Measured: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure

  3. Incidence of Sedation-Related Complications

    Number of participants with hypoxia (peripheral oxygen saturation, SpO2 < 90%), hypotension (mean arterial pressure < 65 mmHg or > 20% decrease from baseline) or bradycardia (heart rate < 50 beats per minute) during the procedure.

    Measured: From induction of sedation to the end of the ERCP procedure

  4. Number of Additional Propofol Boluses

    Number of additional propofol bolus doses given for signs of inadequate sedation (gagging, swallowing, patient movement) during the procedure.

    Measured: From induction of sedation to the end of the ERCP procedure

  5. Time to Discharge Readiness From the Post-Anesthesia Care Unit

    Time (minutes) from the end of the procedure until the patient meets post-anesthesia care unit (PACU) discharge criteria according to the Modified Aldrete Score.

    Measured: From the end of the procedure, up to 2 hours

  6. Need for Airway Intervention

    Number of participants requiring any airway intervention during sedation, recorded by the highest level required: chin lift/jaw thrust, bag-mask ventilation, insertion of an oral/nasal airway or supraglottic device, or endotracheal intubation.

    Measured: From induction of sedation to the end of the ERCP procedure

  7. Mean Arterial Pressure

    Mean arterial pressure (millimeters of mercury, mmHg) measured by non-invasive blood pressure monitoring.

    Measured: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure

  8. Peripheral Oxygen Saturation

    Peripheral oxygen saturation (SpO2, percentage) measured by pulse oximetry.

    Measured: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07922291
Sponsor's protocol ID
2026/07-01
Acronym
BIS-ERCP
Status last verified
Nov 2026
First submitted
26 Oct 2026
Last updated
6 Nov 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. De-identified data may be made available by the corresponding author upon reasonable request.

Publications

  • Kamel Y, Sasa N, Naguib M, Yassen KA, Sayed E. Bispectral Index Guidance Reduced Target Plasma Propofol Concentration During ERCP in Patients with Liver Cirrhosis. Turk J Anaesthesiol Reanim. 2024 Oct 30;52(5):169-179. doi: 10.4274/TJAR.2024.241635.

    PubMed 39478340

  • Inal FY, Daskaya H, Yilmaz Y, Kocoglu H. Evaluation of bispectral index monitoring efficacy in endoscopic patients who underwent retrograde cholangiopancreatography and received sedoanalgesia. Wideochir Inne Tech Maloinwazyjne. 2020 Jun;15(2):358-365. doi: 10.5114/wiitm.2020.93461. Epub 2020 Mar 4.

    PubMed 32489498

Questions about this trial

What is this clinical trial studying?

A study testing BIS-Guided Propofol Titration and Standard Clinical Propofol Titration in people with Deep Sedation and Endoscopic Retrograde Cholangiopancreatography, run by Van Training and Research Hospital 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Nov 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Propofol Consumption (time frame: From induction of sedation to the end of the ERCP procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07922291, which also lists 2 linked publications.

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 6 Nov 2026.

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