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Efficacy and Safety of Early Dexmedetomidine during Non-Invasive Ventilation for Patients with Acute Respiratory Failure: A Randomized, Double-Blind, Placebo-Controlled, Pilot Study.
Chest. 2014 Feb 27;
Authors: Devlin JW, Al-Qadheeb NS, Chi A, Roberts R, Qawi I, Garpestad E, Hill NS
Abstract
BACKGROUND: Successful application of non-invasive ventilation (NIV) for acute respiratory failure (ARF) requires patient cooperation and comfort. The efficacy and safety of early IV dexmedetomidine (D) when added to protocolized prn IV midazolam (M) and fentanyl (F) remains unclear.
METHODS: Adults with ARF and within 8 h of starting NIV were randomized to receive IV D [0.2 mcg/kg/h, titrated q30 min to 0.7 mcg/kg/h to maintain a Sedation-Agitation Scale (SAS) score of 3-4] or placebo (P) in a double-blind fashion up to 72h, until NIV was stopped ≥2 h, or intubation. Patients with agitation (SAS ≥5) or pain (VAS scale ≥5/10), 15 minutes after each D(P) increase, could receive IV M 0.5-1.0mg or IV F 25-50mcg, respectively, at a minimum q3h interval.
RESULTS: The D(n=16) and P(n=17) groups were similar at baseline. Use of early D did not improve NIV tolerance(NIV intolerance score =1 out of 4)[OR=1.44; 95% CI: 0.44 to 4.70, p=0.54), a greater median(IQR) % time either tolerating NIV [99 (61-100)(D) vs. 67 (40-100); p=0.56], remaining at the desired sedation level (SAS=3 or 4) [100 (86-100)(D) vs. 100 (100-100); p=0.28], or fewer intubations (p=0.79). While use of D was associated with a greater duration of NIV [37(16-72) vs. 12(4-22) h; p=0.03], the total ventilation duration (NIV+invasive) [3.3 (2-4)(D) vs. 3.8 (2-5) d; p=0.52] was similar. More D patients had ≥1 episode of deep sedation [SAS ≤ 2; 25 vs. 0%, p=0.04]. Use of M (p=0.40), episodes of either severe bradycardia (HR ≤ 50, p=0.18), or hypotension (SBP ≤ 90, p=0.64) were similar.
CONCLUSION: Initiating D soon after NIV initiation in patients with ARF neither improves NIV tolerance nor helps maintain sedation at a desired goal. Randomized, multicenter trials targeting patients with initial intolerance are needed to further elucidate the role for D in this population.This study is registered on www.ClinicalTrials.gov (# NCT 00871624).
PMID: 24577019 [PubMed - as supplied by publisher]