Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
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| ClinicalTrials.gov Identifier: NCT01006668 |
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Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : November 3, 2009
Last Update Posted : August 29, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endotracheal Intubation | Drug: Administration of sevoflurane Drug: Administration of propofol | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 44 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care |
| Study Start Date : | November 2009 |
| Estimated Primary Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
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Drug: Administration of sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas. |
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Active Comparator: Propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary
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Drug: Administration of propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary. |
- To compare recovery time between sevoflurane and propofol for intubation of neonates. [ Time Frame: 18 months ]
- To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates. [ Time Frame: 18 months ]
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| Ages Eligible for Study: | up to 28 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006668
| Contact: Fabrice MICHEL | fabrice.michel@ap-hm.fr |
| France | |
| Assistance Publique - Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Fabrice MICHEL fabrice.michel@ap-hm.fr | |
| Principal Investigator: Fabrice MICHEL | |
| Principal Investigator: | Fabrice MICHEL | Assistance Publique - Hôpitaux de Marseille |
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT01006668 History of Changes |
| Other Study ID Numbers: |
2009-13 2009-013283-39 |
| First Posted: | November 3, 2009 Key Record Dates |
| Last Update Posted: | August 29, 2014 |
| Last Verified: | August 2014 |
Keywords provided by Assistance Publique Hopitaux De Marseille:
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Neonates Intensive care Endotracheal intubation Neonates in intensive care |
Additional relevant MeSH terms:
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Propofol Sevoflurane Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Anesthetics, Intravenous Anesthetics, General Anesthetics Platelet Aggregation Inhibitors Anesthetics, Inhalation |