Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography (BIS-ERCP)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Van, Turecko (Türkiye)
- University of Health Sciences, Van Training and Research Hospital
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Kontakt:
- Ömer Türk, MD
- Telefonní číslo: +90 506 979 41 95
- E-mail: omer_turk@hotmail.com
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Vrchní vyšetřovatel:
- Ömer Türk, MD
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Dílčí vyšetřovatel:
- Sebat İldoğan, MD
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Dílčí vyšetřovatel:
- Cemal Kaçar, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: BIS-Guided Sedation
Propofol infusion during ERCP is titrated to a target BIS of 40-60 using real-time bispectral index monitoring. |
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. |
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Aktivní komparátor: Standard Clinical Sedation
Propofol infusion during ERCP is titrated according to standard monitoring and clinical signs; BIS values are recorded but hidden from the anesthesia team. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total Propofol Consumption
Časové okno: From induction of sedation to the end of the ERCP procedure
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Total amount of propofol (mg) administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure, including induction, infusion and additional boluses. |
From induction of sedation to the end of the ERCP procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gastroenterologist Satisfaction
Časové okno: Immediately after the end of the ERCP procedure
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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). |
Immediately after the end of the ERCP procedure
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Heart Rate
Časové okno: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Heart rate (beats per minute) measured by standard electrocardiographic monitoring. |
Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Incidence of Sedation-Related Complications
Časové okno: From induction of sedation to the end of the ERCP procedure
|
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. |
From induction of sedation to the end of the ERCP procedure
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Number of Additional Propofol Boluses
Časové okno: From induction of sedation to the end of the ERCP procedure
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Number of additional propofol bolus doses given for signs of inadequate sedation (gagging, swallowing, patient movement) during the procedure. |
From induction of sedation to the end of the ERCP procedure
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Time to Discharge Readiness From the Post-Anesthesia Care Unit
Časové okno: From the end of the procedure, up to 2 hours
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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. |
From the end of the procedure, up to 2 hours
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Need for Airway Intervention
Časové okno: From induction of sedation to the end of the ERCP procedure
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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. |
From induction of sedation to the end of the ERCP procedure
|
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Mean Arterial Pressure
Časové okno: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Mean arterial pressure (millimeters of mercury, mmHg) measured by non-invasive blood pressure monitoring. |
Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Peripheral Oxygen Saturation
Časové okno: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Peripheral oxygen saturation (SpO2, percentage) measured by pulse oximetry. |
Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2026/07-01
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Individual participant data will not be shared publicly. De-identified data may be made available by the corresponding author upon reasonable request.
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