Propofol has been widely utilized for sedation during endoscopic procedures in the last decade. Its safety profile, when administered by properly trained health professionals, is comparable to or even superior to that of other frequently employed sedatives such as meperidine, fentanyl, and benzodiazepines such as midazolam6,8.
We performed a retrospective study to assess the safety of propofol administered via boluses by nurses who were appropriately trained in the drug administration process and patient monitoring during endoscopic procedures. They play a critical role in maintaining the quality and safety of endoscopic procedures. There were few patients who required rescue maneuvers (including the chin-lift maneuver and supplemental oxygen administration), and there was no need for further respiratory assistance in any patient. Similar to other works3,20, in our study, nurse-administered propofol sedation was safe and practical for outpatient gastrointestinal endoscopy.
In this study, we comprehensively documented every event that may be linked to an ADR, even if it was short-lived and appropriately resolved. We reported that 30.8% of the patients experienced at least one ADR during endoscopic intervention. The percentages of almost all the ADRs were consistent with the findings reported by Guzzo et al.21, except for hypoxia, which was lower in our study. This difference could be attributed to our use of a smaller total propofol dose and our decision not to employ additional drugs during the endoscopic procedures22.
All the ADRs we found were of mild or moderate severity. We did not encounter any SAEs in our study. It is possible that the lack of SAEs may be imputed to our sample size. Duprey et al.6 reported serious cardiovascular adverse events (SCAEs) of intravenous sedative drugs over an 8-year period. In the case of propofol (n = 1596), the percentages of patients with one or more SCAE events and the incidence of each SCAE event were 17% and 7 (106 days of sedative exposure), respectively. However, the authors included all reported events for propofol, not limited solely to endoscopic procedures. In another study, Wehrmann and Riphaus23 showed that in a 6-year observation period of patients who received propofol sedation for interventional endoscopic procedures (n = 9547), assisted ventilation was required for 40 patients (0.4%), endotracheal intubation was necessary for 9 patients (0.09%), 28 patients required additional monitoring in the intensive care unit (ICU) (0.3%), and 3 patients likely died due to sedation-related side effects (mortality rate, 0.03%).
Multivariate analyses revealed that an ASA class III was associated with the occurrence of ADRs in patients receiving propofol sedation. However, due to the small number of participants with this ASA classification in our study, this result should still be confirmed. Other studies have documented both significant23,24 and nonsignificant21,25 associations between these variables. These disparities could be explained by differences in the study design, procedure complexity, and type of sedation administered.
A procedure time of more than 20 minutes was another independent risk factor in our study. Gemma et al.24 reported an association between procedure duration and respiratory and cardiovascular adverse events in patients under propofol sedation during endoscopic interventions. This is possibly because prolonged procedures extend the exposure to the occurrence of ADRs in these patients.
On the other hand, the overall recovery time in our study (15 min ± 21) was lower than that in other studies21,26. Although it is difficult to make a direct comparison among these results without a comprehensive understanding of the recovery criteria used in each study, the longer stays observed in the other studies may be related to the use of benzodiazepines26 and higher propofol doses during the process of sedation6. In addition, we showed that patients who experienced ADRs had longer recovery times than patients who did not experience these events.
This study has several limitations. First, the study primarily involved nonadvanced endoscopic procedures (endoscopy, colonoscopy, and endoscopy + colonoscopy), with the majority of patients having an ASA classification of I-II. Consequently, these findings were predominantly obtained within a low-risk context. Second, due to the unavailability of a suitable and accessible ADR data source in Peru27, as well as the Food and Drug Administration’s MedWatch Adverse Event Reporting System in the United States, we could not conduct a study with a large population. Third, this study could only show correlations and not establish causality among these variables. As strengths, this is the first study to evaluate the postmarketing safety profile of the use of propofol in endoscopic procedures in Peru, a low-income country, and it is one of the few such studies carried out in Latin America. This work highlights the importance of multidisciplinary collaboration among doctors, researchers, nurses, and pharmacists to investigate the safety profile of medications. Finally, although we included mainly a low-risk population, they constitute the majority of individuals receiving daily medical care in our country’s hospitals.