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

Phase 4

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT00797160
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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).

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.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-24
• Last Update Submitted: 2008-11-24
• Study First Posted: 2008-11-25
• Last Update Posted: 2008-11-25
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time until extubation after bolus dose as premedication for tracheal intubation	within the first 3 days of life

Secondary Outcome Measures

Name	Time	Method
Quality of intubation with the combination of drugs used for premedication	within the first 2 days of life

Trial Locations

Locations (1)

Department of Neonatology of Julia Kubitschek Hospital; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil