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NCT07922291
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Conditions: Deep Sedation, Endoscopic Retrograde Cholangiopancreatography, Anesthesia Recovery Period
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Van Training and Research Hospital
Location: University of Health Sciences, Van Training and Research Hospital Van
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. 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07922291). StuddyBuddy aggregates publicly available trial information.