Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation

Durrmeyer, Xavier; Breinig, Sophie; Claris, Olivier; Tourneux, P.; Carlos, Alexandre; Saliba, Élie; Beuchée, Alain; Jung, Camille; Lévy, Corinne; Marchand-Martin, Laetitia; Marcoux, Marie-Odile; Dechartres, Agnès; Danan, Claude

doi:10.1001/jama.2018.3708

Cited by 37 publications

(73 citation statements)

References 42 publications

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“…Because of its rapid onset and recovery, and its ease of use, propofol as a sedative for endotracheal intubation has been implemented into clinical practice in several neonatal intensive care units (NICUs) 13–17. Previous trials studying propofol have shown conflicting results on sedative effect and concerning effects on blood pressure 16–19…”

Section: Introductionmentioning

confidence: 99%

“…Used propofol starting doses range from 1.0 to 2.5 mg/kg, with cumulative doses ranging from 1.0 to 6.0 mg/kg for successful intubation 15–19. Although gestational age (GA) and postnatal age (PNA) are important determinants of propofol pharmacokinetics,20 fixed propofol starting doses are often used for the entire neonatal population regardless of GA and PNA.…”

Section: Introductionmentioning

confidence: 99%

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Propofol for endotracheal intubation in neonates: a dose-finding trial

Kort

Prins

Reiss

et al. 2020

Arch Dis Child Fetal Neonatal Ed

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ObjectiveTo find propofol doses providing effective sedation without side effects in neonates of different gestational ages (GA) and postnatal ages (PNA).Design and settingProspective multicentere dose-finding study in 3 neonatal intensive care units.PatientsNeonates with a PNA <28 days requiring non-emergency endotracheal intubation.InterventionsNeonates were stratified into 8 groups based on GA and PNA. The first 5 neonates in every group received a dose of 1.0 mg/kg propofol. Based on sedative effect and side effects, the dose was increased or decreased in the next 5 patients until the optimal dose was found.Main outcome measuresThe primary outcome was the optimal single propofol starting dose that provides effective sedation without side effects in each age group.ResultsAfter inclusion of 91 patients, the study was prematurely terminated because the primary outcome was only reached in 13% of patients. Dose-finding was completed in 2 groups, but no optimal propofol dose was found. Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%). Propofol-induced hypotension occurred in 59% of patients. Logistic regression analyses showed that GA and PNA did not predict effective sedation or the occurrence of hypotension.ConclusionsEffective sedation without side effects is difficult to achieve with propofol and the optimal dose in different age groups of neonates could not be determined. The sedative effect of propofol and the occurrence of hypotension are unpredictable and show large inter-individual variability in the neonatal population.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Propofol for endotracheal intubation in neonates: a dose-finding trial

Kort

Prins

Reiss

et al. 2020

Arch Dis Child Fetal Neonatal Ed

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“…This trial will be the first multicenter, double blind, randomised, placebo controlled trial evaluating premedication before LISA with an expected number of participants of 542. In addition it will examine the neurodevelopmental outcome at 2 years of age of preterm infants who received a few doses of propofol or ketamine shortly after birth [22,44].…”

Section: Discussionmentioning

confidence: 99%

“…Mediali-pide® is used in the control group to ensure that the 2 arms are indistinguishable. Medialipides® is an emulsion of medium and long triglycerides based derived from soya oil and has the same appearance as propofol [20,22].…”

Section: Blindingmentioning

confidence: 99%

“…Propofol might be of interest due to its short action, quick preparation, rapid onset and sedative properties [21]. It has been shown to be a suitable sedative for nonemergent neonatal endotracheal intubation with good tolerance and the possibility of titration [22,23]. An observational study reported a higher level of comfort (ComfortNeo scale) when using premedication with 1 mg/kg propofol for the LISA procedure compared to a historical non-sedated control group [11].…”

Section: Introductionmentioning

confidence: 99%

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Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA)

et al. 2020

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Premedication for Neonates Requiring Nonemergency Intubation

Fideler

Grasshoff

2018

JAMA

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To the Editor Dr Durrmeyer and colleagues 1 investigated 173 neonates requiring nonemergent intubation in a multicenter, double-blind clinical trial, randomly assigning infants to receive atropine-propofol or atropine-atracuriumsufentanil before nasotracheal intubation. The authors reported that "the frequency of prolonged desaturation did not differ significantly [between groups]…. However, the study may have been underpowered to detect a clinically important difference."We would like to raise 2 points of concern regarding this study. First, the potential toxicity of general anesthetics like propofol administered to children receiving general anesthesia is controversial and has led to a warning from the US Food and Drug Administration (FDA). 2 We wonder whether anesthetic toxicity during intubation and sedation of neonates is relevant.Second, we would like to emphasize the occurrence of intraventricular hemorrhage. The authors stated that "the goal of premedication is to prevent pain, because multiple painful experiences in the neonatal period are associated with poor neurodevelopmental outcome." In this study, neonates were exposed to 2.5 mg/kg of propofol for infants weighing more than 1000 g and 1 mg/kg of propofol for those weighing less than 1000 g. Propofol has no analgesic properties, and we are concerned about whether this practice facilitates the occurrence of intraventricular hemorrhage, especially after Friesen et al 3 demonstrated that intracranial pressure increases by almost 200% during intubation. The difference in the number of intraventricular hemorrhages between groups (20.6% in the atropine-propofol group and 17.6% in the atropine-atracurium-sufentanil group; P = .87) may be underestimated due to the greater number of boys (69.5% vs 49.4%) and premature infants with lower median birth weight of 1130 g in the atropine-propofol group vs 1310 g in the atropine-atracurium-sufentanil group. Both parameters previously have been shown to be independent risk factors for intraventricular hemorrhage. 4,5 In our experience, the use of propofol without analgesia for tracheal intubation in neonates should only be recommended cautiously, although there might be a benefit in preservation of oxygen saturation immediately after intubation.

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Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation

Abstract: ClinicalTrials.gov Identifier: NCT01490580, EudraCT number: 2009-014885-25.

Cited by 37 publications

References 42 publications

Propofol for endotracheal intubation in neonates: a dose-finding trial

Propofol for endotracheal intubation in neonates: a dose-finding trial

Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA)

Premedication for Neonates Requiring Nonemergency Intubation

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