Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Time until extubation after bolus dose as premedication for tracheal intubation
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Time until extubation after bolus dose as premedication for tracheal intubation
Time Frame: within the first 3 days of life
Secondary Outcomes
- Quality of intubation with the combination of drugs used for premedication(within the first 2 days of life)