Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)
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ClinicalTrials.gov Identifier: NCT00797160
Recruitment Status : Unknown
Verified August 2008 by Federal University of Minas Gerais. Recruitment status was: Recruiting
The aim of the study is to compare the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome. At the same time, to show the group of drugs that could let the neonates with no residual sedation after the use of surfactant (the possibility of the premature neonates to be readily extubated after the use of surfactant).
Condition or disease
Respiratory Distress Syndrome
It has been demonstrated that remifentanil, due to it its very short context-sensitive, has an interesting potential for use in premature neonates with respiratory distress syndrome. Indeed, remifentanil allowed an adequate level of sedation and analgesia as well as rapid recovery after discontinuation. The aim of the present study was to compares the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome.
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Ages Eligible for Study:
up to 2 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Gestational age between 28-34 wk
Clinical and radiological features compatible with respiratory distress syndrome that required elective tracheal intubation and surfactant therapy
Hemodynamic stability before tracheal intubation
Signature (parents) consent form
The presence of major congenital malformations
Birth weigh less than 1000 g
Previous use of opioid or other sedative drug for any reason
Previous tracheal intubation
Hemodynamic instability before the indication of tracheal intubation
Refuse of the parents to enroll the neonate in the study protocol
SILVA,Y.P. et al. Morphine versus remifentanil for intubating preterm neonates. Short report.Archives of Disease in Childhood Fetal & Neonatal Edition;92:4.2007. Dani C, Bertini G, Pezzati M, et al. Early Extubation and Nasal Continuous Positive Airway Pressure After Surfactant Treatment for Respiratory Distress Syndrome Among Preterm Infants <30 Weeks' Gestation. Pediatrics 2004; 113:560-563. Carbajal R, Eble B, Anand KJS. Premedication for Tracheal Intubation in Neonates: Confusion or Controversy? Seminars in Perinatology 2007; 31:309-317. Silva YP, Gomez RS, Marcatto JO, et al. Early awakening and extubation with remifentanil in ventilated premature neonates. Pediatric Anesthesia 2008; 18:176-183. Welzing L, Roth B. Experience with remifentanil in neonates and infants. Drugs 2006; 66(10):1339-1350.
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Yerkes Pereira e Silva, Federal University of Minas Gerais