(336) Prevalence and risk factors associated with adverse drug reactions to propofol used during interventional endoscopic procedures in a Peruvian population: cross-sectional study

Background: Propofol sedation is commonly employed for diagnostic procedures, surgeries, and periods when patients require mechanical ventilation to ensure their comfort and safety. Although trained physicians usually administer this drug, its use can potentially result in the occurrence of adverse drug reactions (ADRs). The number of post-marketing studies on the use of propofol in endoscopic procedures is still small and the ADR frequency associated with this intravenous sedative remains poorly characterized in developing countries such as Peru.

Objectives: The purpose of this observational study was to describe the prevalence of ADR related to propofol and to identify its potential risk factors when it is used during interventional endoscopic procedures in a Peruvian population.

Methods: We conducted a cross-sectional study. We reviewed medical records from a database with outpatients who received an endoscopic intervention performed under sedation with propofol. Patients between 18 and 69 years old, who had American Society of Anesthesiologists (ASA) physical status classification scores I–III, and who were hemodynamically stable with oxygen saturation (SO2)>90% before the procedure were included. Causality and severity were established for each ADR. Chi-square tests were conducted to explore contributing factors for the presence of ADRs, while a robust Poisson regression model was run to evaluate the significant association. Prevalence ratios (PR) with a 95% confidence interval (CI), and p< 0.05 were used to determine statistical significance.

Results: A total of 693 patients (47.41 ± 12.23 yo) were included in this research. The majority of the individuals were women, 62.4% (n=434). In total, 230 ADRs (with causality scores classified as probable or definitive) were reported and all of them related to the cardiovascular or respiratory systems. We found that 35.8% (n=87) and 64.2% (n=143) of the reported ADRs set had moderate and mild severity, respectively. No serious ADRs were found in this study. The prevalence of patients with at least one ADR reported was 30.88% (n=214). We found that only two variables showed a significant association with the presence of propofol’s ADR. The level III ASA classification (p=0.048, PR adjusted (PRa) =1.73, 95% CI: 1.01-2.99) and a procedure time equal to or more than 20 minutes (p>0.0001, PRa=2.05, and 95% CI: 1.53-2.73). Finally, we found that patients who reported at least one ADR had a higher recovery time in comparison to patients who did not present any ADR (22 min ± 22.5 vs 14 min ± 8, respectively; p< 0.0001).

Conclusions: Propofol sedation is not risk-free for interventional endoscopy. Monitoring vital parameters is especially important during long-term interventions and for patients with level III ASA classification.