Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Phase 3

• Conditions: Endotracheal Intubation
• Interventions: Drug: Administration of propofol; Drug: Administration of sevoflurane

• Registration Number: NCT01006668
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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).

Study Timeline

• Study First Submitted: 2009-10-19
• Study Start: 2009-11
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29
• Primary Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Administration of propofol	Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary
Sevoflurane	Administration of sevoflurane	Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.

Primary Outcome Measures

Name	Time	Method
To compare recovery time between sevoflurane and propofol for intubation of neonates.	18 months

Secondary Outcome Measures

Name	Time	Method
To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.	18 months

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Marseille; 🇫🇷 Marseille, France