GP3d - Are There Any Risk Factors for Serious Adverse Events in Procedural Outpatient Sedations by Oral and Maxillofacial Surgeons?

Abstract:

Background: The use of outpatient procedural sedation in oral and maxillofacial surgery (OMS) clinics has been shown to have a low incidence of serious adverse events. However, these studies are either dated or restricted to a few institutions. As this practice continues to face legislative risk, additional data is required to evaluate the safety of outpatient procedural sedation by OMS.

Purpose: The purpose of this study was to determine the frequency of serious adverse events and related factors in subjects undergoing outpatient procedural sedation by oral and maxillofacial surgeons. Study

Design/Methods: The authors conducted a retrospective cohort study of subjects who underwent procedural deep sedation or general anesthesia in the OMS outpatient clinics at Geisinger Health System from September 2017 to July 2022. The primary outcome variable was the presence of a serious adverse event, defined as mortality, hospitalization, aspiration, complete laryngospasm, respiratory failure, arrhythmia, angina, myocardial infarction, heart failure, cardiac arrest, stroke, deep venous thrombosis, and pulmonary embolism. Subjects that were identified as having a serious adverse event underwent extensive chart review. Potential predictor variables examined for a possible association with serious adverse events were age, sex, American Society of Anesthesiologists Physical Status Classification System score, smoking status, recreational drug use, body mass index, procedure type, anesthetic agents administered, and adjunctive agents administered. Subjects with incomplete medical records, procedures performed in the operating room setting, and procedures performed utilizing modalities other than intravenous deep sedation/general anesthesia were excluded. Analysis: Descriptive statistics were used to describe the study variables. Bivariate analyses describing the association between the study variables and the primary outcome were performed using Wilcoxon sum-rank tests for continuous variables and chi square and Fisher’s exact tests for the categorical variables.

Results: The study sample consisted of 5,295 subjects over the study time period. The mean age was 25.0 ± 11.8 years and there were 3,332 females (62.9%) and 1,963 males (37.1%). There were 5 serious adverse events (.09%) and 0 deaths (0%). The serious events included two subjects with complete laryngospasms, one subject hospitalized on postoperative day 3 for suicidal ideations, one subject hospitalized for severe trismus and dysphagia without cellulitis/abscess formation on postoperative day 3, and one subject hospitalized on postoperative day 0 for acute diverticulitis, which was surgically managed. No significant association was measured between serious adverse events and age (P = .87), sex (P = .66), ASA Score (P = .57), Smoking (P = .09), recreational drug use (P = .56), BMI (P = .85), procedure type (P = .99), midazolam use or dosage (P = .99 and P = .62, respectively), fentanyl use or dosage (P = .39 and P = .62, respectively), propofol use or dosage (P = .65 and P = .36, respectively), dexamethasone use (P = .99), ketorolac use (P = .47), ondansetron use (P = .27) or glycopyrrolate use (P = .10). However, subjects with serious adverse events received a statistically higher dose of ketamine (48.0 ± 30.5 vs 22.7 ± 26.0, P = .03).

Conclusion: Serious adverse events are rare in outpatient sedations performed by oral and maxillofacial surgery. A single factor was found in the study to be significantly associated with serious adverse outcome: a higher ketamine dose. This finding has not been described in previous studies on this topic, but could be explained by an unmeasured confounder, such as sedation difficulty, or could represent a type II error. ReferencesWiemer SJ, Nathan JM, Heggestad BT, Fillmore WJ, Viozzi CF, Van Ess JM, Arce K, Ettinger KS. Safety of Outpatient Procedural Sedation Administered by OMS: The Mayo Clinic Experience in 17,634 Sedations (2004 to 2019). J Oral Maxillofac Surg. 2021 May;79(5):990-999. doi: 10.1016/j.joms.2020.12.002. Epub 2020 Dec 5. PMID: 33382992. Braidy HF, Singh P, Ziccardi VB. Safety of deep sedation in an urban oral and maxillofacial surgery training program. J Oral Maxillofac Surg. 2011 Aug;69(8):2112-9. doi: 10.1016/j.joms.2011.04.017. PMID: 21783001.

Table 1. Summary of the sample’s descriptive statistics. Abbreviations: ASA, American Society of Anesthesiologists.
Table 2. Bivariate analysis of covariates versus Serious Adverse Event status. Wilcoxon sum-rank tests were used to compare continuous variables and Chi square and Fisher exact tests were used to compare categorical variables. Abbreviations: ASA, American Society of Anesthesiologists.
Table 3.