The safety of deep sedation with propofol controlled by the endoscopist in endoscopic retrograde cholangiopancreatography (ERCP): a prospective study in a tertiary hospital.

ABSTRACT

INTRODUCTION: propofol administered by an endoscopist with a trained nurse has evolved as an alternative to anesthesia monitoring and is increasingly common in the routine clinical practice, even in advanced endoscopy. OBJECTIVE: to evaluate the safety of deep sedation with endoscopist-controlled propofol in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). MATERIAL AND METHODS: this was a prospective study in patients undergoing ERCP under deep sedation with propofol. Different patient-related variables were included and the initial and final data on oxygen saturation (SatO2), blood pressure (BP) and heart rate (HR) were recorded in order to determine the presence of adverse events due to sedation (hypoxemia, hypotension, or bradycardia). RESULTS: a total of 661 patients underwent ERCP under sedation with propofol over a 24-month period. The rate of recorded adverse events was 9.7%. The most frequent adverse event was hypoxemia (5.7%), followed by bradycardia (2.4%) and hypotension (1.6%). According to the univariate analysis, the occurrence of adverse events due to sedation (AES) was associated with an ASA score ≥ III (p = 0.026), older patients (p = 0.009), higher body mass index (BMI) (p = 0.002) and a longer exploration time (p = 0.034). The induction dose of propofol was also associated with a greater likelihood of adverse events (p = 0.045) but not the total dose of propofol administered (p = 0.153). According to the multivariate logistic regression analysis, age, body mass index (BMI) and the duration of the exploration were independent predictors of SAE (p < 0.05). CONCLUSION: deep sedation with propofol controlled by trained endoscopy staff is a safe method in complex endoscopic procedures such as ERCP.