Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS) - Full Text View

Sponsored by:	Federal University of Minas Gerais
Information provided by:	Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT00797160

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 IV

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Propofol Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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:

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

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, Minas Gerais
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

Responsible Party:	Federal University of Minas Gerais ( Yerkes Pereira e Silva )
Study ID Numbers:	0011.0.287.000-08
Study First Received:	November 20, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797160
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:

propofol
midazolam
neonate
tracheal intubation

Study placed in the following topic categories:

Remifentanil
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome
Propofol
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants

Pharmacologic Actions
Adjuvants, Anesthesia
Pathologic Processes
Anesthetics, General
Syndrome
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009