An interventional study of BIS-Guided Propofol Titration and Standard Clinical Propofol Titration in Deep Sedation, Endoscopic Retrograde Cholangiopancreatography and Anesthesia Recovery Period, sponsored by Van Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Van Training and Research Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Van Training and Research Hospital is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Propofol infusion during ERCP is titrated to a target BIS of 40-60 using real-time bispectral index monitoring.
Device: BIS-Guided Propofol Titration
Propofol infusion during ERCP is titrated according to standard monitoring and clinical signs; BIS values are recorded but hidden from the anesthesia team.
Other: Standard Clinical Propofol Titration
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.
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.
Total Propofol Consumption
Total amount of propofol (mg) administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure, including induction, infusion and additional boluses.
Time frame: From induction of sedation to the end of the ERCP procedure
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).
Time frame: Immediately after the end of the ERCP procedure
Heart Rate
Heart rate (beats per minute) measured by standard electrocardiographic monitoring.
Time frame: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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.
Time frame: From induction of sedation to the end of the ERCP procedure
Number of Additional Propofol Boluses
Number of additional propofol bolus doses given for signs of inadequate sedation (gagging, swallowing, patient movement) during the procedure.
Time frame: From induction of sedation to the end of the ERCP procedure
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.
Time frame: From the end of the procedure, up to 2 hours
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.
Time frame: From induction of sedation to the end of the ERCP procedure
Mean Arterial Pressure
Mean arterial pressure (millimeters of mercury, mmHg) measured by non-invasive blood pressure monitoring.
Time frame: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2, percentage) measured by pulse oximetry.
Time frame: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available by the corresponding author upon reasonable request.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Van Training and Research Hospital