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Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01006668
Enrollment
44
Registered
2009-11-03
Start date
2009-11-30
Completion date
Unknown
Last updated
2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation

Keywords

Neonates, Intensive care, Endotracheal intubation, Neonates in intensive care

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).

Interventions

Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.

Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To compare recovery time between sevoflurane and propofol for intubation of neonates.18 months

Secondary

MeasureTime frame
To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.18 months

Countries

France

Contacts

Primary ContactFabrice MICHEL
fabrice.michel@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026