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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Federal University of Minas Gerais.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00797160
First received: November 20, 2008
Last updated: November 24, 2008
Last verified: August 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797160

Contacts
Contact: Yerkes P Silva, PhD 00553199933384 yerkesps@uol.com.br
Contact: Márcia G Penido, MD 00553193047238 mgpenido@gmail.com

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

No publications provided

Responsible Party: Yerkes Pereira e Silva, Federal University of Minas Gerais
ClinicalTrials.gov 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
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
propofol
midazolam
neonate
tracheal intubation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Midazolam
Propofol
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014