Safety and Efficacy of Propofol only sedation in Oral and Maxillofacial Surgery - Pilot Study

Propofol has been gaining increased attention as a sole agent in providing procedural sedation due to its predictable pharmacokinetics and favorable amnestic properties. Oral and maxillofacial surgical procedures are unique in duration and concomitant use of local anesthesia making it difficult to evaluate data obtained from other specialties.¹ On review of the OMS literature regarding this topic, a lack of internally and externally validated research was discovered. The purpose of our study is to evaluate the safety, efficacy and satisfaction among surgeons and patients using propofol only, for procedural sedation during the extraction of third molars. The Capital Health Research Ethics Board granted ethics approval for this prospective clinical trial. Patients scheduled to undergo third molar surgery at the Atlantic Center for Maxillofacial Surgery, were approached to participate in the study. A RN assessed all patients pre operatively and verified NPO status. Propofol 10mg/ml was administered using an induction dose of 0.5 to 1mg/kg over 60 seconds followed by bolus doses of 10 – 20mg every minute to achieve a Ramsay sedation score of at least 3.² Non-invasive blood pressure monitoring, 3 lead electrocardiogram (EKG), pulse oximetry, capnography, and Ramsay sedation score were monitored throughout the procedure. Local anesthesia consisted of Lidocaine 2% with 1:100,000 epinephrine. Patients received oxygen at a rate of 2 liters per minute via nasal cannula.

Respiratory compromise was defined as apnea for more than 30 seconds or an oxygen saturation of less than 90%. Hemodynamic compromise was defined as a systolic blood pressure of less than 90 mm Hg or a decrease from baseline of > 20%. Major complications were defined as bag-valve-mask ventilation, intubation, aspiration, blood pressure or heart rate interventions, or unplanned hospital admission, and death.  Furthermore, the “Quebec Criteria” for reporting adverse events was also used to facilitate future efforts in comparing procedural sedation outcomes. Patient recovery was assessed using an Aldrete recovery room assessment. Surgeon satisfaction and surgical difficulty were also evaluated. Between 24 and 48 hours post operative, a follow up patient survey was conducted via phone to assess patient satisfaction and recall. Data was analyzed using SPSS 17.0 using descriptive statistics. 25 patients have completed the study. The sedation was successful in 100% of cases allowing completion of all cases enrolled. Respiratory compromise occurred in 3/25 patients (12%) when the patients SpO2 briefly dropped below 90% with the lowest being 87%. Suctioning or airway repositioning allowed the SpO2 to return to baseline. 7 additional patients (28%) experienced either partial or complete upper airway obstruction that was corrected via chin lift jaw thrust. These were not associated with oxygen desaturation however were captured in our data collection using the aforementioned Quebec criteria. Hemodynamic compromise occurred in 3 patients (12%). Two of these patients had systolic pressures that dropped below 90mmHg and one had systolic pressure that dropped below 20% of their baseline, to 97mmHg. No interventions were required and all pressures improved spontaneously. The 24-hour post operative survey showed that only 2 patient (9.1%) could recall unpleasant experiences. Estimated anxiety during the operation was ranked from 0 to 10. Average anxiety was rated 0.35 (std. deviation 1.112). There were no major complications. Patients reached an Aldrete score of 10 at a mean of 2.95 minutes and surgeon satisfaction was high. It was concluded that propofol only sedation is both safe and effective for the removal of third molars.

 

1. Zed PJ, et al. Efficacy, safety and patient satisfaction of propofol for procedural sedation and analgesia in the emergency department: a prospective study. CJEM. 2007 Nov;9(6):421-7.

 

2. Ramsay MA, et al. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9.