One-stage Adjustable Strabismus Surgery Under AIVOC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Need for a second adjustement time
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Need for a second adjustement time
时间窗: The day after the intervention
Use of a second adjustment time the day after surgery
次要结局
- Patient comfort assessment questionnaire(5 minutes after the end of the intervention)
- Patient satisfaction questionnaire(5 minutes after the end of the intervention)
- Digital visual scale to assess pain of patient(Before the intervention, before the intervention and one month after the intervention)