Safety of Propofol and Methohexital Use in Office-Based Procedures

Abstract

Statement of the Problem: Oral and maxillofacial surgeons (OMSs) are trained to provide anesthesia and perform surgical procedures in an office-based ambulatory setting. Propofol and methohexital sodium are often administered as anesthetic agents because of their rapid onset, effectiveness, and short duration. However, the propofol package insert states that it “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.” The purpose of this study is to compare the safety and anesthetic outcomes of propofol, methohexital, and benzodiazepines during oral and maxillofacial surgery outpatient procedures in which the OMS is both the anesthesia provider and the surgeon working with a team of assistants. Materials and Methods: This prospective cohort study, conducted by the AAOMS Outcomes Assessment Project, included a consecutive series of patients who underwent oral and maxillofacial surgery outpatient procedures in office-based ambulatory settings between January 2001 and December 2004. The procedures were performed by OMSs who volunteered to submit studyrelated data to a specialty-specific data repository. To be included in this study, the patient underwent conscious sedation or deep sedation/general anesthesia (DS/GA) and received a benzodiazepine, methohexital, or propofol. Patients given other sedative agents, such as ketamine, or a combination of sedative agents were excluded. Demographic information of the patient population included age, gender, and anesthetic risk classified according to the ASA system. Additional study variables included operative procedure, anesthetic monitoring, adverse events, and patient-oriented outcomes. Method of Data Analysis: Fisher’s exact test was used to compare the complications between each of three sedative regimens. The level of statistical significance was set at p 0.05. Results: Ninety-four volunteer OMSs submitted data for 27,162 patients who met the study criteria. Mean patient age was 29.2 years (range 1-101). The patients were relatively healthy with 20,551 (75.5%) classified as ASA I and 5,997 (22.0%) as ASA II. Over 70% of the procedures were third molar extractions, while the rest were other dentoalveolar procedures, implants, trauma, reconstruction, and pathology. Patients were categorized on the basis of the sedative regime they received: 15,428 (56.8%) received methohexital (with or without a benzodiazepine), 7,625 (28.1%) received propofol (with or without a benzodiazepine), and 4,109 (15.1%) received a benzodiazepine but no methohexital or propofol. Overall, 318 (1.2%) patients developed a complication from the anesthesia. The most common was postoperative nausea and vomiting without aspiration (68 patients, 0.3%). There were no deaths, but 6 patients required hospitalization. No patient in the study suffered any long-term effects. When comparing the anesthetic agents and the number of complications with each agent, propofol regimens resulted in 58 complications (0.8% of the patients receiving propofol), benzodiazepines resulted in 37 (0.9% of those receiving benzodiazepines without propofol or methohexital), and methohexital incurred 223 complications (1.4% of patients receiving methohexital). There was no statistically significant difference between the number of complications when using propofol than when using benzodiazepines without propofol or methohexital. However, there was a statistically significant difference between methohexital and benzodiazepines without propofol or methohexital (p 0.007), and between methohexital and propofol (p 0.0001). Methohexital demonstrated a higher number of complications in both comparisons. Conclusion: The overall proportion of patients who experienced complications was found to be extremely low (1.2%) and the complications that did occur were minor without any long-term effects. In addition, the number of complications while administering propofol, or benzodiazepines is statistically significantly less than methohexital. These results support the use of propofol by OMSs when administering the anesthetic and performing the procedure.