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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00797160
• Other study ID #: 0011.0.287.000-08
• Status: Unknown status
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: November 24, 2008
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Federal University of Minas Gerais
• Contact: Yerkes P Silva, PhD
• Phone: 00553199933384
• Email: yerkesps[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• propofol
2mg/Kg IV in bolus before tracheal intubation

Locations

Country	Name	City	State
Brazil	Department of Neonatology of Julia Kubitschek Hospital	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

SILVA,Y.P. et al. Morphine versus remifentanil for intubating preterm neonates. Short report.Archives of Disease in Childhood Fetal & Neonatal Edition;92:4.2007. Dani C, Bertini G, Pezzati M, et al. Early Extubation and Nasal Continuous Positive Airway Pressure After Surfactant Treatment for Respiratory Distress Syndrome Among Preterm Infants <30 Weeks' Gestation. Pediatrics 2004; 113:560-563. Carbajal R, Eble B, Anand KJS. Premedication for Tracheal Intubation in Neonates: Confusion or Controversy? Seminars in Perinatology 2007; 31:309-317. Silva YP, Gomez RS, Marcatto JO, et al. Early awakening and extubation with remifentanil in ventilated premature neonates. Pediatric Anesthesia 2008; 18:176-183. Welzing L, Roth B. Experience with remifentanil in neonates and infants. Drugs 2006; 66(10):1339-1350.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until extubation after bolus dose as premedication for tracheal intubation		within the first 3 days of life
Secondary	Quality of intubation with the combination of drugs used for premedication		within the first 2 days of life