Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endotracheal Intubation
Intervention: Administration of sevoflurane (Drug); Administration of propofol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assistance Publique Hopitaux De Marseille Official(s) and/or principal investigator(s): Fabrice MICHEL, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Marseille
Overall contact: Fabrice MICHEL, Email: fabrice.michel@ap-hm.fr
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.
Clinical Details
Official title: Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To compare recovery time between sevoflurane and propofol for intubation of neonates.
Secondary outcome: To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.
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).
Eligibility
Minimum age: N/A.
Maximum age: 28 Days.
Gender(s): Both.
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
Locations and Contacts
Fabrice MICHEL, Email: fabrice.michel@ap-hm.fr
Assistance Publique - Hôpitaux de Marseille, Marseille, France; Recruiting Fabrice MICHEL, Email: fabrice.michel@ap-hm.fr Fabrice MICHEL, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: August 28, 2014
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