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Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Federal University of Minas Gerais.
Recruitment status was:  Recruiting
Information provided by:
Federal University of Minas Gerais Identifier:
First received: November 20, 2008
Last updated: November 24, 2008
Last verified: August 2008
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 Intervention Phase
Respiratory Distress Syndrome
Drug: propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome

Resource links provided by NLM:

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Time until extubation after bolus dose as premedication for tracheal intubation [ Time Frame: within the first 3 days of life ]

Secondary Outcome Measures:
  • Quality of intubation with the combination of drugs used for premedication [ Time Frame: within the first 2 days of life ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: propofol
    2mg/Kg IV in bolus before tracheal intubation
Detailed Description:
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.

Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00797160

Contact: Yerkes P Silva, PhD 00553199933384
Contact: Márcia G Penido, MD 00553193047238

Department of Neonatology of Julia Kubitschek Hospital Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30620470
Contact: Márcia G Penido, MD    00553193047238   
Principal Investigator: Márcia G Penido, MD         
Sponsors and Collaborators
Federal University of Minas Gerais
Principal Investigator: Yerkes P Silva, PhD Federal University of Minas Gerais
  More Information

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.

Responsible Party: Yerkes Pereira e Silva, Federal University of Minas Gerais Identifier: NCT00797160     History of Changes
Other Study ID Numbers: 0011.0.287.000-08
Study First Received: November 20, 2008
Last Updated: November 24, 2008

Keywords provided by Federal University of Minas Gerais:
tracheal intubation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017