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

Federal University of Minas Gerais

Status and phase

Unknown

Phase 4

Conditions

Respiratory Distress Syndrome

Treatments

Drug: propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT00797160

0011.0.287.000-08

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

30 minutes to 2 days old

Volunteers

No Healthy Volunteers

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