- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02700893
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.
Primary outcome:
- Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
- Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Créteil, France, 94000
- Hôpital Intercommunal de Créteil
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Toulouse, France, 31059
- Hopital des Enfants
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Corrected age < 45 weeks of gestational age
- Currently hospitalized in a neonatal intensive care unit
- Requiring semi-urgent or elective intubation
- Equipped with a reliable and permeable IV line
- Parental consent
Exclusion Criteria:
- Lack of parental consent
- Parental refusal
- Sedative or anesthetic treatment in the previous 24 hours
- Hemodynamic compromise defined as mean blood pressure< corrected GA and/or refill time > 3 seconds
- Upper airway malformation
- Life-threatening situation requiring immediate intubation
- Inclusion in another trial not permitting any other participation
- Impossibility to establish venous access
- Any contra-indication to any experimental drug
- Skin lesions or burns of the forehead
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atropine + propofol
Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
|
Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
|
Active Comparator: Atropine + atracurium + sufentanil
Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
|
Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral desaturation
Time Frame: from 1 minute before to 60 minutes after the start of premedication
|
rScO2 delta >20% from the baseline value (before premedication).
rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection
|
from 1 minute before to 60 minutes after the start of premedication
|
FTOE (Fractional Tissue Oxygen Extraction)
Time Frame: from 1 minute before to 60 minutes after the start of premedication
|
Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection. |
from 1 minute before to 60 minutes after the start of premedication
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Meryl Vedrenne-Cloquet, MD, CHI Créteil
- Study Director: Xavier Durrmeyer, MD, PhD, CHI Créteil
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Neuromuscular Agents
- Mydriatics
- Nicotinic Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Propofol
- Atropine
- Sufentanil
- Atracurium
Other Study ID Numbers
- PRETTINEO sub-study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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