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

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).

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: propofol

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yerkes P Silva, PhD; Phone Number: 00553199933384; Email: yerkesps@uol.com.br
• Study Contact Backup: Name: Márcia G Penido, MD; Phone Number: 00553193047238; Email: mgpenido@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30620470
      • Recruiting
      • Department of Neonatology of Julia Kubitschek Hospital
      • Contact: Márcia G Penido, MD; Phone Number: 00553193047238; Email: mgpenido@gmail.com
      • Principal Investigator: Márcia G Penido, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: November 20, 2008
• First Submitted That Met QC Criteria: November 24, 2008
• First Posted (Estimate): November 25, 2008

Study Record Updates

• Last Update Posted (Estimate): November 25, 2008
• Last Update Submitted That Met QC Criteria: November 24, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: midazolam; propofol; neonate; tracheal intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 0011.0.287.000-08