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One-stage Adjustable Strabismus Surgery Under AIVOC

One-stage Adjustable Strabismus Surgery Under AIVOC

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04261699
Acronym
AIVOC
Enrollment
159
Registered
2020-02-10
Start date
2020-01-28
Completion date
2021-07-31
Last updated
2021-08-25

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

Conditions

Strabismus, Surgery

Keywords

Adjustable strabismus surgery, Target-controlled infusion of Propofol-Reminfentanyl

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.

Interventions

None listed

Sponsors

Clinique Saint Jean, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Need for a second adjustement timeThe day after the interventionUse of a second adjustment time the day after surgery

Secondary

MeasureTime frameDescription
Patient comfort assessment questionnaire5 minutes after the end of the interventionThis is a question to determine the comfort of the patient immediatly after the intervention. Very comfortable Comfortable Less comfortable Uncomfortable Very uncomfortable
Digital visual scale to assess pain of patientBefore the intervention, before the intervention and one month after the interventionNumeric scale numbered from 0 to 10. 0 : no pain, 10 : worst pain possible
Patient satisfaction questionnaire5 minutes after the end of the interventionNumeric scale numbered from 0 to 10. 0 : unsatisfied, 10 : very satisfied

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026