Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Unknown; Phase 3

Conditions: Endotracheal Intubation

Treatments: Drug: Administration of sevoflurane; Drug: Administration of propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01006668

2009-013283-39

2009-13

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Sevoflurane

Experimental group

Description:

Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.

Treatment:

Drug: Administration of sevoflurane

Propofol

Active Comparator group

Description:

Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary

Treatment:

Drug: Administration of propofol