Remifentanil for endotracheal intubation in neonates: a dose-finding trial.
Phase 1
Recruiting
- Conditions
- Hemodynamic stable term and preterm neonates requiring semi-elective endotracheal intubation.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- CTIS2022-501858-11-00
- Lead Sponsor
- niversitair Ziekenhuis Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Hemodynamic stable term or preterm neonate (normal mean blood pressure, without use of inotropic agents or vasopressors., Requiring semi-elective endotracheal intubation., Minimum of 26 weeks gestational age., Written informed consent obtained from the legal representatives.
Exclusion Criteria
5th min Apgar score less than 5., Maxillofacial anomalies., Anticipated difficult airwaiy (e.g. airway anomaly or obstruction)., Concurrent or recent intravenous opioids infusions within 24 hours of the procedure., Neonates from non-Dutch speaking parents, Infants born via cesarian section under general anesthesia 12 hours prior to enrollment., Neonates from mothers with recent drug abuse, Prior enrollment in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method