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临床试验/NCT02282787
NCT02282787Unknown3 期

DEXMEDETOMIDINE ADJUVANT TO LOCAL ANAESTHESIA FOR PERIBULBAR BLOCKS IN RETINAL SURGERY

King Saud University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
90
试验地点
1
主要终点
onset, duration of the motor and sensory block

研究概览

简要总结

During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration and unexpected globe movement .so many adjuvant was added to LA to overcome this disadvantages of LA such as clonidine and fentanyl .

The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine adjuvant to local anaesthetic in ophthalmic surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Going for elective vitreoretinal surgery.

排除标准

  • History of coagulation abnormalities.
  • Allergy to local anesthetics.
  • Cardiac, hepatic or renal failure,
  • Chronic clonidine or analgesic therapy.
  • One-eyed patients

研究组 & 干预措施

5 micron dex arm

Experimental

干预措施: DEXMEDETOMIDINE (Drug)

10 micron dex arm

Experimental

干预措施: DEXMEDETOMIDINE (Drug)

结局指标

主要结局

onset, duration of the motor and sensory block

时间窗: 10 minutes from injection

A block was considered satisfactory when complete akinesia occurred. In the absence of complete akinesia in any direction after 10 min, supplementary anesthesia given by a further injection of 2-4 ml of the test solution in the same manner as given before. Calculate the number of patients needed supplemental block were. The surgeon assessed the duration of surgery anesthesia and akinesia. Intraocular pressure measured before block, immediately after block and before surgical procedures

次要结局

  • observe the adverse effects of Dexmedetomidine(during and after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwan Abouammoh

Associate professor

King Saud University

研究点 (1)

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