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临床试验/NCT01677351
NCT01677351Unknown2 期

Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
40
试验地点
1
主要终点
intensity of pain

研究概览

简要总结

Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias for cataract surgery.

详细描述

After approved by the Ethical Committee and signed informed consent, 40 patients aged from 40 until 80 years undergoing cataract extraction will be randomized in two groups. Exclusion criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency, chronic use of beta-blockage channel drugs. Group 2, patients will receive a single dose of 4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will receive a sterile saline solution dose. Pain intensity will be assessed with the numeric rating scale. The antiarrythmic effect will be assessed with the continuous measure by Holter. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cataract surgery
  • topical anesthesia

排除标准

  • myocardial ischemia
  • psychiatric disease
  • chronic pain
  • drugs dependency
  • use of beta-blockage channel drugs

研究组 & 干预措施

group 2: clonidine 4mcg.kg

Active Comparator

this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.

干预措施: Clonidine (Drug)

Group 1: sterile saline solution

Placebo Comparator

this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery

干预措施: placebo (Drug)

结局指标

主要结局

intensity of pain

时间窗: 30 minutes before surgery, during the surgery

Pain intensity will be assessed by numeric rating scale.

次要结局

  • intraocular pressure(30 minutes and during the surgery)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Ellen de Queiroz Santiago

medical resident, principal investigator

Federal University of São Paulo

研究点 (1)

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