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Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

NCT01006668 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-08-29

No results posted yet for this study

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.

Conditions

  • Endotracheal Intubation

Interventions

DRUG

Administration of sevoflurane

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

DRUG

Administration of propofol

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

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Fabrice MICHEL · Assistance Publique - Hôpitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006668 on ClinicalTrials.gov