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Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography (BIS-ERCP)

1 november 2026 uppdaterad av: Ömer TÜRK, Van Training and Research Hospital

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Turkiet (Türkiye)
      • Van, Turkiet (Türkiye)
        • University of Health Sciences, Van Training and Research Hospital
        • Kontakt:
        • Huvudutredare:
          • Ömer Türk, MD
        • Underutredare:
          • Sebat İldoğan, MD
        • Underutredare:
          • Cemal Kaçar, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: BIS-Guided Sedation

Propofol infusion during ERCP is titrated to a target BIS of 40-60 using real-time bispectral index monitoring.
Enhet: BIS-Guided 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.
Aktiv komparator: 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.
Övrig: Standard Clinical Propofol Titration

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total Propofol Consumption
Tidsram: From induction of sedation to the end of the ERCP procedure

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Gastroenterologist Satisfaction
Tidsram: Immediately after the end of the ERCP procedure

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

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
Incidence of Sedation-Related Complications
Tidsram: 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
Number of Additional Propofol Boluses
Tidsram: From induction of sedation to the end of the ERCP procedure

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
Time to Discharge Readiness From the Post-Anesthesia Care Unit
Tidsram: From the end of the procedure, up to 2 hours

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
Need for Airway Intervention
Tidsram: From induction of sedation to the end of the ERCP procedure

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
Mean Arterial Pressure
Tidsram: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure

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
Peripheral Oxygen Saturation
Tidsram: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure

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

Samarbetspartners och utredare

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Sponsor

Van Training and Research Hospital

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

1 april 2027

Avslutad studie (Beräknad)

1 april 2027

Studieregistreringsdatum

Först inskickad

26 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

1 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2026/07-01

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IPD-planbeskrivning

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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