Determination of the ED95 of intranasal sufentanil combined with intranasal dexmedetomidine for moderate sedation during endoscopic ultrasonography

Abstract

BACKGROUND Sedation during endoscopic ultrasonography (EUS) poses many challenges and moderate-to-deep sedation are often required. The conventional method to preform moderate-to-deep sedation is generally intravenous benzodiazepine alone or in combination with opioids. However, this combination has some limitations. Intranasal medication delivery may be an alternative to this sedation regimen. AIM To determine, by continual reassessment method (CRM), the minimal effective dose of intranasal sufentanil (SUF) when combined with intranasal dexmedetomidine (DEX) for moderate sedation of EUS in at least 95% of patients (ED95). METHODS Thirty patients aged 18-65 and scheduled for EUS were recruited in this study. Subjects received intranasal DEX and SUF for sedation. The dose of DEX (1 μg/kg) was fixed, while the dose of SUF was assigned sequentially to the subjects using CRM to determine ED95. The sedation status was assessed by modified observer’s assessment of alertness/sedation (MOAA/S) score. The adverse events and the satisfaction scores of patients and endoscopists were recorded. RESULTS The ED95 was intranasal 0.3 μg/kg SUF when combined with intranasal 1 μg/kg DEX, with an estimated probability of successful moderate sedation for EUS of 94.9% (95% confidence interval: 88.1%-98.9%). When combined with intranasal 1 μg/kg DEX, probabilities of successful moderate sedation at each dose level of intranasal SUF were as follows: 0 μg/kg SUF, 52.8%; 0.1 μg/kg SUF, 75.4%; 0.2 μg/kg SUF, 89.9%; 0.3 μg/kg SUF, 94.9%; 0.4 μg/kg SUF, 98.0%; 0.5 μg/kg SUF,99.0%. CONCLUSION The ED95 needed for moderate sedation for EUS is intranasal 0.3 μg/kg SUF when combined with intranasal 1 μg/kg DEX, based on CRM.