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NCT01006668 Clinical Trial

Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Endotracheal Intubation Clinical Trial

Official title:
Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01006668
Other study ID # 2009-13
Secondary ID 2009-013283-39
Status Recruiting
Phase Phase 3
First received October 19, 2009
Last updated August 28, 2014
Start date November 2009

Study information
Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact Fabrice MICHEL
Email fabrice.michel@ap-hm.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 28 Days
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Administration of sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
• Administration of propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.

Locations
Country Name City State
France Assistance Publique - Hôpitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare recovery time between sevoflurane and propofol for intubation of neonates. 18 months Yes
Secondary To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates. 18 months Yes
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