Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Study Overview
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Brief Summary
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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 high morbidity. 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.

Detailed Description
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Background: 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).

Official Title
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Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Drug: Administration of sevoflurane
* Drug: Administration of propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates Hospitalized in neonatal intensive care unit Needing of an endotracheal intubation Exclusion Criteria: Emergency state Predictable difficult endotracheal intubation Decrease of blood pressure Neurological disorders Morphinic treatment

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas. | Drug: Administration of sevoflurane<br>* Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.<br>|
| Active Comparator: Propofol<br>Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary | Drug: Administration of propofol<br>* Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare recovery time between sevoflurane and propofol for intubation of neonates. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonates, Intensive care, Endotracheal intubation, Neonates in intensive care