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Effet of curarization under general anaesthesia on eye movements in non-strabismus children - STRABO

Effet of curarization under general anaesthesia on eye movements in non-strabismus children - STRABO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021022-35-FR
Enrollment
Unknown
Registered
2010-06-15
Start date
2010-10-12
Completion date
Unknown
Last updated
2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer who will have a surgery requiring curare administration (amygdalectomy...) MedDRA version: 12.1 Level: LLT Classification code 10042609 Term: Surgery MedDRA version: 12.1 Level: LLT Classification code 10057290 Term: Curarization

Interventions

Trade Name: Atracrurium HOSPIRA Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ATRACURIUM BESILATE CAS Number: 64228815 Concentration unit: mg/kg milligram(s)/kilogram Concentration ty

Sponsors

CHU de Saint-Etienne
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 - Measure the horizontal deviation, the eye by eye under deep curarisée general anesthesia ;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

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026