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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | 2mg/Kg IV in bolus before tracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Time until extubation after bolus dose as premedication for tracheal intubation | within the first 3 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of intubation with the combination of drugs used for premedication | within the first 2 days of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yerkes P Silva, PhD | Contact | 00553199933384 | yerkesps@uol.com.br | |
| Márcia G Penido, MD | Contact | 00553193047238 | mgpenido@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yerkes P Silva, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology of Julia Kubitschek Hospital | Recruiting | Belo Horizonte | Minas Gerais | 30620470 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2011 | |
| Reset | Jul 22, 2011 | |
| Release | Jul 24, 2014 | |
| Unrelease | Yes | |
| Release | Aug 3, 2014 | |
| Unrelease | Yes | |
| Release | Aug 5, 2014 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2011 | Jul 22, 2011 | |||
| Jul 24, 2014 |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Yes |
| Aug 3, 2014 | Yes |
| Aug 5, 2014 | Yes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |