Effect of Neuromuscular Blockade on the Oculomotor by Not Squinting Child

NCT ID: NCT02360969

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-12-31

Brief Summary

Strabismus is a common condition (4-6% of the population) . The screening and treatment is a public health issue. Indeed, beyond the disfigurement, this disease is very supplier of amblyopia which is definitive if it is not detected and treated early (before 6 years old).

Initial treatment of strabismus is medical with orthoptic reeducation through penalization of the better eye in case of amblyopia or wearing optical correction in case of associated refractive disorder.

The second step is the treatment of strabismus is the surgery, when medical treatment has not resulted in a recovery of the visual axes. The principle of surgery is to weaken or strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint deviation. The main difficulty of surgical treatment is to assess the amount of strengthening or weakening muscles to do in order to obtain the best result and for a long time.

The investigators know that the postmortem anatomical position of the eyes is generally a slight elevation and divergence, but is inferior to the angle of divergence of the orbital axes. Curare and similar products which inhibit the nervous transmission at the neuromuscular junction, can be used to reproduce this situation in normal subjects.

The sign of general anesthesia is then to evaluate the angle of strabismus when the patient is under deep general anesthesia and with a complete muscle relaxation, obtained only when curarised it. If one or both eyes are recovering under general anesthesia, strabismus is mainly due to dynamic changes and surgery limiting muscle play (wire operation) and sometimes one eye is justified. A combination of both is possible (down + wireless), guided by the importance of the sign of general anesthesia on two prominent eyes or one eye. This sign of general anesthesia is however less known and most poorly quantified in healthy subjects. Yet it seems very important to determine what is deviation in normal subjects after neuromuscular blockade, as his eye movement is also subject to mechanical factors and spastic. This would indicate whether the state of rectitude (no strabismus) is the result of a deviation at complete rest (appearing under general anesthesia) and corrected by spastic elements wakefulness or, in another case this righteousness is already present in the state of general anesthesia (due to static factors) and slightly modified by enlightenment.

Conditions

Strabismus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy subjects waiting for surgery

patients for whom surgery under general anesthesia with administration of curare is planned will be offered an examination of the eyes before and during surgery

Examination of the eye

Intervention Type: OTHER

Before planed surgery, an ophthalmologist measures the patient's visual acuity and realise an oculomotor examination. Measurement the refraction and the axial length of the eye is performed. Photographs wakefulness are performed.

During surgery, participation in this study does not involve any change in the course of anesthesia and surgery.

Pictures of the eye will be performed under general anesthesia.

Timing photos will be dictated by the values of BIS and train-of-four (TOF). Photos will be conducted at different times, with the "top" given by the anesthetist under the following conditions:

Deep anesthesia: BIS <50 Deep anesthesia and muscle relaxation: BIS <50 and TOF 0/4

Interventions

Examination of the eye

Before planed surgery, an ophthalmologist measures the patient's visual acuity and realise an oculomotor examination. Measurement the refraction and the axial length of the eye is performed. Photographs wakefulness are performed.

During surgery, participation in this study does not involve any change in the course of anesthesia and surgery.

Pictures of the eye will be performed under general anesthesia.

Timing photos will be dictated by the values of BIS and train-of-four (TOF). Photos will be conducted at different times, with the "top" given by the anesthetist under the following conditions:

Deep anesthesia: BIS <50 Deep anesthesia and muscle relaxation: BIS <50 and TOF 0/4

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• normal visual acuity for age: 10/10 (Test of Cadet) Rossano 2 for 4-6 years old. 10/10 (scale Monoyer) Parnaud 1.5 for 7-15 years old.
• normal oculomotor examination: Examination under normal alternating display eliminating strabismus
• Binocular vision less than or equal to 60 sec/arc for the stereoscopic vision test
• Refraction WITHOUT cycloplegia within normal limits: below 2 dioptries myopia, hyperopia less than 1.5d, below 1 dioptry astigmatism, anisometropia less than 1 dioptry.
• Examination of the fundus without normal pupillary dilation
• Axial length 6 normal for age as measured by noncontact biometer to eliminate refractive offset anomaly axial length by abnormal

Exclusion Criteria

• presence of anterior eye history
• children whose behavior suggests a poor cooperation when taking photo awakeness
• children with abnormal limb
• scheduled surgery without the use of curare

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre PM MANOLI, M.D

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

Centre Hospitalier Universitaire de Saint Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

2010-021022-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0908125

Identifier Type: -

Identifier Source: org_study_id