Addition of neuromuscular-blocking agents during induction in infants: potential interest in reducing episodes of oxygen decrease in blood
Phase 1
- Conditions
- Chirurgie programmée sous anesthésie générale avec intubation orotrachéale, avec induction inhalatoire prévueMedDRA version: 21.0Level: LLTClassification code 10002326Term: Anesthetic inductionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2015-001668-21-FR
- Lead Sponsor
- Fondation Ophtalomologique A. de Rothschild
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 412
Inclusion Criteria
- Age <2 years
- Indication of general anesthesia with orotracheal intubation
- Inhalational induction scheduled
- Free, written and informed consent of both parents to participate in the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 412
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Contraindication to:
. inhalation induction (stomach full)
. the use of rocuronium (intubating scheduled difficult, documented allergy ...)
- ASA III or IV
- Intracranial surgery
- parental refusal
- no affiliation to French public wellfare system
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