Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Endotracheal Intubation	Drug: Administration of sevoflurane; Drug: Administration of propofol	Phase 3

Detailed Description:

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).

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Study Start Date :	November 2009
Estimated Primary Completion Date :	November 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Sevoflurane; Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.	Drug: Administration of sevoflurane; Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
Active Comparator: Propofol; Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary	Drug: Administration of propofol; Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To compare recovery time between sevoflurane and propofol for intubation of neonates. [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates. [ Time Frame: 18 months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 28 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Fabrice MICHEL		fabrice.michel@ap-hm.fr

Locations

France
Assistance Publique - Hôpitaux de Marseille	Recruiting
Marseille, France
Contact: Fabrice MICHEL fabrice.michel@ap-hm.fr
Principal Investigator: Fabrice MICHEL

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:	Fabrice MICHEL	Assistance Publique - Hôpitaux de Marseille

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT01006668 History of Changes
Other Study ID Numbers:	2009-13; 2009-013283-39
First Posted:	November 3, 2009
Last Update Posted:	August 29, 2014
Last Verified:	August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:

Neonates; Intensive care; Endotracheal intubation; Neonates in intensive care

Additional relevant MeSH terms:

Propofol; Sevoflurane; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs	Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation