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One-stage Adjustable Strabismus Surgery Under AIVOC

C

Clinique Saint Jean, France

Status

Completed

Conditions

Strabismus
Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04261699
LOCAL2019-EL01

Details and patient eligibility

About

The purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type AIVOC (Target-controlled infusion of Propofol-Remifentanyl)

Full description

Adjustable surgery is a surgical treatment technique for strabismus and oculomotor paralysis well known and widely used around the world. The adjustable surgery is done in 2 steps. The first step, performed under general anesthesia, is practically the same as "classic" strabismus surgery however one or more muscles are fixed by temporary sutures. In a second time once the patient is awake and after a new clinical examination the sutures are adjusted and definitively fixed. The adjustment is sometimes made the same day but more often the day after the first intervention because it requires a state of consciousness close to normal.

Anesthesia type Intravenous Intensity Concentration Anesthesia (AIVOC) allows the realization of a surgery under anesthesia general deep (choice of a cerebral or plasma anesthetic target suitable for surgery) but allows a programmed awakening, very fast in full consciousness, condition of an immediate reliable adjustment practically upon stopping the infusion of the anesthetic agent.

The goal is to present an adjustable surgery technique simplified from a logistical point of view since performed in a single step thanks to the contribution of Intravenous Anesthesia with Concentration Objective (AIVOC) and to show that its results are equivalent to a second deferred time.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with medical insurance
  • Major patient requiring a strabismus surgery
  • Patient who received information about study and not having expressed their opposition to participate in the study

Exclusion criteria

  • Minor patient
  • Patient participation in another interventional study
  • Patient having expressed their opposition to participate in the study
  • Patient for whom it is impossible to give informed information
  • Patient under the protection of justice, under curatorship ou under tutorship

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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