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临床试验/NCT02327156
NCT02327156已完成3 期

The Effect of a Low-dose Dexmedetomidine as an Adjuvant to Levobupivacaine in Patients Undergoing Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Magrabi Eye & Ear Hospital0 个研究点目标入组 60 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
状态
已完成
发起方
入组人数
60
主要终点
the motor and sensory block durations

研究概览

简要总结

The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.

详细描述

Background: The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.

Methods: The investigator investigated 60 patients subjected to vitreoretinal surgery under sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups conferring to the local anesthesia (LA) solution used to receive either 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block (akinesia) and sensory block durations were evaluated until the return of normal motor and sensory function. The sedation level was assessed during the surgery period and 24 hours postoperatively together with the degree of postoperative pain and the efficiency of postoperative analgesia. The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary (CSD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • incorporated patients younger than 18 years,
  • patients with a single eye,
  • history of sleep apnea,
  • severe cardiac disease, and
  • drug abuse or
  • if there was any contraindication to LA.

研究组 & 干预措施

group LD

Active Comparator

4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline

干预措施: dexmedetomidine (Drug)

结局指标

主要结局

the motor and sensory block durations

时间窗: participants will be followed for the duration of hospital stay, an expected average of 24 hours

expected to be extended in group LD

次要结局

  • sleep quality of the 1st postoperative night(24 hours)

研究者

发起方
Magrabi Eye & Ear Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashraf M Ghali

SENIOR CONSULTANT

Magrabi Eye & Ear Hospital

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