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临床试验/NCT04956237
NCT04956237已完成不适用

Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort

Hopital Foch2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2021年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
164
试验地点
2
主要终点
Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia

研究概览

简要总结

Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head.

Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist.

The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route.

To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia.

This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route.

For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients over 18 years old
  • Patients with an indication for retinal surgery
  • Not having opposed to participate in the study

排除标准

  • Claustrophobia
  • Unbalanced psychiatric pathology
  • Inability to lie down
  • Deprived of liberty or under guardianship.

结局指标

主要结局

Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia

时间窗: At the surgery

Number of eye or head movements of the patient during the operation

次要结局

  • Comparison of the patient's comfort during the operation between the 2 groups(15 minutes after the end of the surgery)
  • Comparison of the patient's comfort during the operation between the 2 groups regarding pain(Preoperative, peroperative and 15 minutes post surgery)
  • Assessement of the security between the 2 groups(At the end of the surgery)
  • Comparison of operating time between the 2 groups(At the end of the surgery)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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