Clinical trial NCT01006668: Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Official title: Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endotracheal Intubation
Keywords: Neonates
Intensive care
Endotracheal intubation
Neonates in intensive care
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 44
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: To compare recovery time between sevoflurane and propofol for intubation of neonates.
timeFrame: 18 months
Secondary outcomes:
measure: To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: Fabrice MICHEL
role: PRINCIPAL_INVESTIGATOR
References: