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OpenTrials
Completed

NCT Number: NCT04261699

One-stage Adjustable Strabismus Surgery Under AIVOC

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint Jean

Montpellier, Hérault, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Need for a second adjustement time

    Time frame: The day after the intervention

    Use of a second adjustment time the day after surgery

Secondary outcomes

  1. Digital visual scale to assess pain of patient

    Time frame: Before the intervention, before the intervention and one month after the intervention

    Numeric scale numbered from 0 to 10. 0 : no pain, 10 : worst pain possible

  2. Patient comfort assessment questionnaire

    Time frame: 5 minutes after the end of the intervention

    This is a question to determine the comfort of the patient immediatly after the intervention.

    Very comfortable Comfortable Less comfortable Uncomfortable Very uncomfortable

  3. Patient satisfaction questionnaire

    Time frame: 5 minutes after the end of the intervention

    Numeric scale numbered from 0 to 10. 0 : unsatisfied, 10 : very satisfied

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Acronym: AIVOC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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