Endotracheal IntubationPhase 3NCT01006668
Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
A Phase 3 study testing Administration of sevoflurane and Administration of propofol in people with Endotracheal Intubation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Administration of sevoflurane and Administration of propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates
- Hospitalized in neonatal intensive care unit
- Needing of an endotracheal intubation
Who cannot join
- Emergency state
- Predictable difficult endotracheal intubation
- Decrease of blood pressure
- Neurological disorders
- Morphinic treatment
Trial locations and contacts
1 site in 1 country.
Fabrice MICHEL contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille
Fabrice MICHEL, fabrice.michel@ap-hm.fr
Fabrice MICHEL
About this study
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.
Read the 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).
- Conditions
- Endotracheal Intubation
- Being tested
- Administration of sevoflurane, Administration of propofol
- Keywords
- Neonates, Intensive care, Endotracheal intubation, Neonates in intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of sevofluraneDrug
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
Administration of propofolDrug
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas. Receives: Drug: Administration of sevoflurane |
| Propofol | Active comparator | Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary Receives: Drug: Administration of propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare recovery time between sevoflurane and propofol for intubation of neonates.
Measured: 18 months
Secondary outcomes (1)
To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice MICHEL, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006668
- Sponsor's protocol ID
- 2009-13
- Other IDs
- 2009-013283-39, 2009
- Status last verified
- Aug 2014
- First submitted
- 19 Oct 2009
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT01006668
- Acronym / sponsor ID
- 2009-13
- Conditions
- Endotracheal Intubation
- Keywords
- Neonates, Intensive care, Endotracheal intubation, Neonates in intensive care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2014 (estimated)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Administration of sevofluraneAdministration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas. |
| Propofol | Active comparator | Drug: Administration of propofolAdministration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates
- Hospitalized in neonatal intensive care unit
- Needing of an endotracheal intubation
Key exclusion criteria (5 listed)
- Emergency state
- Predictable difficult endotracheal intubation
- Decrease of blood pressure
- Neurological disorders
- Morphinic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of sevofluraneAdministration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas. | Drug | Sevoflurane |
| Administration of propofolAdministration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary. | Drug | Propofol |
Primary outcome
To compare recovery time between sevoflurane and propofol for intubation of neonates.
Time frame: 18 months
1 secondary outcome
To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice MICHEL contact
Fabrice MICHEL principal investigator
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of sevoflurane and Administration of propofol in people with Endotracheal Intubation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrice MICHEL (fabrice.michel@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare recovery time between sevoflurane and propofol for intubation of neonates. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.