Clinical trial NCT04261699: One-stage Adjustable Strabismus Surgery Under AIVOC
Official title: One-stage Adjustable Strabismus Surgery Under AIVOC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus
Surgery
Keywords: Adjustable strabismus surgery
Target-controlled infusion of Propofol-Reminfentanyl
Lead sponsor: Clinique Saint Jean, France
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patient requiring a strabismus surgery not having expressed their oppostion to participate in the study and eligible for anesthesia of type AIVOC.

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for a second adjustement time
timeFrame: The day after the intervention
Secondary outcomes:
measure: Digital visual scale to assess pain of patient
timeFrame: Before the intervention, before the intervention and one month after the intervention
measure: Patient comfort assessment questionnaire
timeFrame: 5 minutes after the end of the intervention
measure: Patient satisfaction questionnaire
timeFrame: 5 minutes after the end of the intervention
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Saint Jean
state: Hérault
Study officials:
affiliation: Clinique Saint Jean, Montpellier
name: Erick LAURENT, MD
role: PRINCIPAL_INVESTIGATOR
References:
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