DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endotracheal Intubation

Intervention: Administration of sevoflurane (Drug); Administration of propofol (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Assistance Publique Hopitaux De Marseille

Official(s) and/or principal investigator(s):
Fabrice MICHEL, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Marseille

Overall contact:
Fabrice MICHEL, Email: fabrice.michel@ap-hm.fr

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.

Clinical Details

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

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

Primary outcome: To compare recovery time between sevoflurane and propofol for intubation of neonates.

Secondary outcome: To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.

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

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

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

Locations and Contacts

Fabrice MICHEL, Email: fabrice.michel@ap-hm.fr

Assistance Publique - Hôpitaux de Marseille, Marseille, France; Recruiting
Fabrice MICHEL, Email: fabrice.michel@ap-hm.fr
Fabrice MICHEL, Principal Investigator
Additional Information

Starting date: November 2009
Last updated: August 28, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017