Sevoflurane Versus Propofol for Intubation in Neonatal In... | NCT01006668

Studies
Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

NCT01006668

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Aug 29, 2014Estimated

Enrollment

44Estimated

Phase

Phase 3

Conditions

Endotracheal Intubation

Interventions

Administration of sevoflurane
Administration of propofol

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-013283-39

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2014Estimated

Completion Date

Not provided

First Submitted Date

Oct 19, 2009

First Submission Date that Met QC Criteria

Nov 2, 2009

First Posted Date

Nov 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2014

Last Update Posted Date

Aug 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental	Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.	Drug: Administration of sevoflurane
Propofol	Active Comparator	Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary	Drug: Administration of propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Administration of sevoflurane	Drug	Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.	Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare recovery time between sevoflurane and propofol for intubation of neonates.		18 months

Secondary Outcomes

Measure	Description	Time Frame
To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.		18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fabrice MICHEL	Contact			fabrice.michel@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Fabrice MICHEL	Assistance Publique - Hôpitaux de Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique - Hôpitaux de Marseille	Recruiting	Marseille			France