One-stage Adjustable Strabismus Surgery Under AIVOC

Surgery Clinical Trial

— AIVOC  

Official title:

One-stage Adjustable Strabismus Surgery Under AIVOC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261699
• Other study ID #: LOCAL2019-EL01
• Status: Completed
• Start date: January 28, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Clinique Saint Jean, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Strabismus
• Surgery

Locations

Country	Name	City	State
France	Clinique Saint Jean	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Jean, France

Country where clinical trial is conducted

France, 

References & Publications (11)

Bleik JH, Karam VY. Comparison of the immediate with the 24-hour postoperative prism and cover measurements in adjustable muscle surgery: is immediate postoperative adjustment reliable? J AAPOS. 2004 Dec;8(6):528-33. — View Citation

Farr AK, Guyton DL. Strabismus after retinal detachment surgery. Curr Opin Ophthalmol. 2000 Jun;11(3):207-10. Review. — View Citation

Garrity JA. The surgical management of Graves' ophthalmopathy. Curr Opin Ophthalmol. 1994 Oct;5(5):39-44. Review. — View Citation

Hakim OM, El-Hag YG, Haikal MA. Strabismus surgery under augmented topical anesthesia. J AAPOS. 2005 Jun;9(3):279-84. — View Citation

Hassan S, Haridas A, Sundaram V. Adjustable versus non-adjustable sutures for strabismus. Cochrane Database Syst Rev. 2018 Mar 12;3:CD004240. doi: 10.1002/14651858.CD004240.pub4. Review. — View Citation

Karaba VL, Elibol O. One-stage vs. two-stage adjustable sutures for the correction of esotropia. Strabismus. 2004 Mar;12(1):27-34. — View Citation

Morris RJ, Luff AJ. Adjustable sutures in squint surgery. Br J Ophthalmol. 1992 Sep;76(9):560-2. Review. — View Citation

Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Ophthalmic Nurs Technol. 2000 May-Jun;19(3):142-7. Review. — View Citation

Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Pediatr Ophthalmol Strabismus. 1999 May-Jun;36(3):112-7; quiz 134-5. Review. — View Citation

Tatham A, Amaya L. Immediate post-operative adjustable suture strabismus surgery using a target-controlled infusion of propofol-remifentanil. Ophthalmologica. 2009;223(3):192-5. doi: 10.1159/000200766. Epub 2009 Feb 10. — View Citation

Vallés-Torres J, Garcia-Martin E, Fernández-Tirado FJ, Gil-Arribas LM, Pablo LE, Peña-Calvo P. Contact topical anesthesia versus general anaesthesia in strabismus surgery. Arch Soc Esp Oftalmol. 2016 Mar;91(3):108-13. doi: 10.1016/j.oftal.2015.11.012. Epub 2015 Dec 30. English, Spanish. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for a second adjustement time	Use of a second adjustment time the day after surgery	The day after the intervention
Secondary	Digital visual scale to assess pain of patient	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
Secondary	Patient comfort assessment questionnaire	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
Secondary	Patient satisfaction questionnaire	Numeric scale numbered from 0 to 10. 0 : unsatisfied, 10 : very satisfied	5 minutes after the end of the intervention