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

Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00797160

Enrollment

Registered

2008-11-25

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2008-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

propofol, midazolam, neonate, tracheal intubation

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.

Interventions

DRUGpropofol

2mg/Kg IV in bolus before tracheal intubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Minutes to 2 Days

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

* 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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Contacts

Primary ContactYerkes P Silva, PhD

yerkesps@uol.com.br00553199933384

Backup ContactMárcia G Penido, MD

mgpenido@gmail.com00553193047238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026