Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
NCT ID: NCT01006668
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
44 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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The aim of the study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.
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Detailed Description
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Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with hight morbidity.
In 2001, in France more than 50% of intubations in neonates were performed without any premedication or anesthesia.
The most frequently used anesthesias are based on benzodiazepine or opioids. Unfortunately, these treatments are responsible for respiratory and hemodynamic adverse effects. Recently, 2 new possibilities for anesthesia before intubation has been tested: propofol was better than association of morphine, succinylcholine and atropine and we shaw that inhaled sevoflurane was better than no treatment.
The aim of the present study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.
Objectives:
The objective of this study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation of neonates.
Methods:
Prospective, controlled, randomized, monocentric study.
Subjects:
Neonates in neonatal intensive care requiring intubation.
Evaluation criteria:
Recovery time after intubation, facilitation of procedure, tolerance of treatment (mean arterial pressure, apnea).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
Administration of sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
Propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary
Administration of propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.
Interventions
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Administration of sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
Administration of propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized in neonatal intensive care unit
* Needing of an endotracheal intubation
Exclusion Criteria
* Predictable difficult endotracheal intubation
* Decrease of blood pressure
* Neurological disorders
* Morphinic treatment
28 Days
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Fabrice MICHEL
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Marseille
Locations
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Assistance Publique - Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-013283-39
Identifier Type: -
Identifier Source: secondary_id
2009-13
Identifier Type: -
Identifier Source: org_study_id
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