Safety and efficacy of drug-induced sleep endoscopy using a probability ramp propofol infusion system in patients with severe obstructive sleep apnea

Abstract

Background: Drug-induced sleep endoscopy (DISE) uses sedative-hypnotics to induce moderate obstruction in sleep apnea patients, thereby facilitating anatomic assessment of obstructive physiology. Implementation of DISE with propofol requires a dosing strategy that reliably and efficiently produces obstruction while minimizing oxygen desaturation.

Methods: The surgeon in a prospective study of transoral robotic resection of the tongue base enrolled 97 patients with obstructive sleep apnea confirmed by polysomnography who failed continuous positive airway pressure. All patients were screened by DISE. Propofol dose was determined using custom software written in MATLAB, which has been previously described. Studies were performed in an operating room with standard monitors and resuscitation equipment. No topical anesthesia was used, and no IV drugs other than propofol were used. All patients received 2 L/min supplemental oxygen via a nasal cannula placed in the mouth. After initiation of propofol sedation, a pediatric bronchoscope was positioned via the naris to observe the velopharynx. The sedation sequence was continued until the clinical end point of obstruction onset was noted. Observation of the pharynx was performed for a sufficient period to obtain images of the anatomic site(s) of obstruction. The infusion was then terminated. Statistical analysis was performed with MATLAB (MathWorks, version 2012b). Comparison of saturation nadirs between DISE and subject sleep studies was performed with both the paired and unpaired Student t test.

Results: The subject population was characterized by a median body mass index of 32.1 (interquartile range [IQR] 6.8) kg/m and apnea-hypopnea index of 48 (IQR 32). All patients demonstrated obstruction within the design variables. Obstruction was observed after 236 (±57.9) seconds at an estimated effect-site concentration of 4.2 ± 1.3 mcg/mL. The median saturation nadir during DISE was significantly higher (91.4% (IQR 5.1)) than that during standard sleep studies (81.0% [IQR 11.2], P < 0.0001). Ninety-five percent confidence intervals for correlations between DISE saturation nadir and body mass index, age, apnea-hypopnea index, or administered propofol dose included zero in all cases.

Conclusions: A propofol infusion strategy that requires limited experience with propofol dose selection and only 1 pump dosing change reliably produced airway obstruction in patients with severe sleep apnea. Clinical obstruction was achieved faster than target-controlled infusion-based systems for similar procedures reported in the literature. The observed degree of oxygen desaturation in the model system was within a clinically acceptable range.