Propofol Clinical Trial
Official title:
Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study
Many studies address safety and effectiveness of non-anesthesiologist propofol sedation
(NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for
providing optimal sedation regimen and avoiding under or oversedation.
This randomized double blind controlled study compares standard moderate sedation level of
sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS
(group P).
70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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