Durrmeyer X, et al. - Researchers compared prolonged desaturation with atropine-propofol vs atropine-atracurium-sufentanil treatment during neonatal nasotracheal intubation after premedication. Findings revealed no significant differences regarding the frequency of prolonged desaturation between atropine used with propofol or atropine used with atracurium and sufentanil among neonates undergoing nonemergency nasotracheal intubation.

Methods

• Researchers undertook a multicenter, double-blind, randomized clinical trial (2012-2016) in 6 NICUs in France.
• The trial included 173 neonates requiring nonemergency intubation.
• Due to expired study kits and lack of funding, the study was interrupted.
• Before nasotracheal intubation, they randomly assigned 89 participants to the atropine-propofol group and 82 to the atropine-atracurium-sufentanil group.
• Prolonged desaturation (Spo₂ <80% lasting > 60 seconds), using intention-to-treat analysis using mixed models was assessed as the primary outcome.
• The characteristics of the procedure and its tolerance were assessed as the secondary outcomes.

Results

• Researchers randomized 173 neonates (mean gestational age, 30.6 weeks; mean birth weight, 1502 g; 71 girls); 171 of these (99%) completed the trial.
• Fifty three (59.6%) of 89 infants in the atropine-propofol group vs 54 of 82 (65.9%) in the atropine-atracurium-sufentanil group achieved the primary outcome (adjusted RD, -6.4; 95% CI, -21.0 to 8.1; P=.38).
• The atropine-propofol group compared to the atropine-atracurium-sufentanil group had a longer mean procedure duration(adjusted RD, 1.7 minutes; 95% CI, 0.1-3.3 minutes; P=.04); a less frequent excellent quality of sedation rate, 51.7% (45 of 87) vs 92.6% (75 of 81; P < .001); a shorter median time to respiratory recovery, 14 minutes (IQR, 8-34 minutes) vs 33 minutes (IQR, 15-56 minutes; P=.002), and shorter median time to limb movement recovery, 18 minutes (IQR, 10-43 minutes) vs 36 minutes (IQR, 19-65 minutes; P=.003).
• Spo₂ was preserved significantly better in the atropine-propofol group in the 60 minutes after inclusion(time×treatment interaction P=.02).
• They noted that 20.6% of the atropine-propofol group had head ultrasound scans that showed worsening intracranial hemorrhaging (any or increased intraventricular hemorrhage) in the 7 days after randomization vs 17.6% in the atropine-atracurium-sufentanil group (adjusted RD, 1.2; 95% CI, -13.1 to 15.5, P=.87).
• In 11% of the atropine-propofol group and 20% of the atropine-atracurium-sufentanil group, severe adverse events occurred.