Effet of curarization under general anaesthesia on eye movements in non-strabismus children - STRABO
- Conditions
- Healthy volunteer who will have a surgery requiring curare administration (amygdalectomy...)MedDRA version: 12.1Level: LLTClassification code 10042609Term: SurgeryMedDRA version: 12.1Level: LLTClassification code 10057290Term: Curarization
- Registration Number
- EUCTR2010-021022-35-FR
- Lead Sponsor
- CHU de Saint-Etienne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Parents (or holders of the parental authority) having signed the form of consent
- Children from 4 to 15 years old and 3 months and seen in consultation of anesthesia for a surgical operation requiring a general anesthesia with curarization
- Normal ophtalmological assessment
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
- Presence of a previous ophtalmological history
- Children whose behavior lets augur of an inferior cooperation during the taking of photos
- Children presenting an abnormality of the limb
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Measure the effect of the deep general anesthesia with curarisation on the total horizontal deviation of the eyes of non-strabismus children;Secondary Objective: - Measure the total horizontal deviation of eyes under deep general anesthesia, before the injection of the curare <br>- Measure the horizontal deviation, the eye by eye under deep curarisée general anesthesia<br>;Primary end point(s): The total horizontal deviation of 2 eyes under deep AG (determined by the BIS < 50) curarized (determined by TOF=0/4) compared with the position of globes in the waking state
- Secondary Outcome Measures
Name Time Method