One-stage Adjustable Strabismus Surgery Under AIVOC (AIVOC)

August 24, 2021 updated by: Clinique Saint Jean, France
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)

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34000
        • Clinique Saint Jean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for a second adjustement time
Time Frame: The day after the intervention
Use of a second adjustment time the day after surgery
The day after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before the intervention, before the intervention and one month after the intervention
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
5 minutes after the end of the intervention
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
5 minutes after the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Saint Jean, France

Investigators

  • Principal Investigator: Erick LAURENT, MD, Clinique Saint Jean, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2020

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

July 31, 2021

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (ACTUAL)

February 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL2019-EL01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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