Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2014 by Assistance Publique Hopitaux De Marseille

Sponsor:

Information provided by (Responsible Party):

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT01006668

First received: October 19, 2009

Last updated: August 28, 2014

Last verified: August 2014

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:

Drug Information available for: Propofol Sevoflurane

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:	November 2014 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT01006668 History of Changes
Other Study ID Numbers:	2009-13, 2009-013283-39
Study First Received:	October 19, 2009
Last Updated:	August 28, 2014
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 Anesthetics, General Anesthetics, Inhalation Anesthetics, Intravenous Central Nervous System Agents	Central Nervous System Depressants Hematologic Agents Hypnotics and Sedatives Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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