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Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01006668
First received: October 19, 2009
Last updated: May 18, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Endotracheal Intubation
 Drug: Administration of sevoflurane
Drug: Administration of propofol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To compare recovery time between sevoflurane and propofol for intubation of neonates. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: November 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006668

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Marseille, Direction de la Recherche
ClinicalTrials.gov Identifier: NCT01006668     History of Changes
Other Study ID Numbers: 2009-13, 2009-013283-39
Study First Received: October 19, 2009
Last Updated: May 18, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
Neonates
Intensive care
Endotracheal intubation
Neonates in intensive care

Additional relevant MeSH terms:
Propofol
Sevoflurane
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 21, 2013