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临床试验/NCT04184141
NCT04184141Unknown4 期

The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction

Istanbul Medeniyet University0 个研究点目标入组 90 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
90
主要终点
preopartive anxiety

研究概览

简要总结

Patients will be divided into three groups. Group H patients will be given 100 mg Hydroxyzine orally 1 hour before surgery while group A patients will receive 0.5 mg Alprazolam orally. group P will be placebo group. Amsterdam Preoperative Anxiety and Knowledge Scale (APAIS) anxiety scores will be evaluated and recorded 1 hour before surgery. APAIS score will be evaluated again in the the operation room before surgery started. After base measurements of patients are recorded with standard monitoring, spinal block will be performed with 15 mg Heavy Bupivacaine from the L2-L3 or L3-L4 levels of spinal cord in sting position. When T10 level sensory block and Bromage 0-1 neuromusculer block will be occured , surgery will be started. Heart rate, non-invasive arterial blood pressure and the degree of peripheral O2 saturation will be measured at 5 minutes interval throughout the operation. IOWA anesthesia satisfaction scale will also performed to the patients the day after the surgery.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • sacrococcygeal dermoid cyst patients
  • Saceptance of spinal anaesthesia
  • between 18-60 years old patients

排除标准

  • drug allergy
  • BMI>35kg/m2
  • psychiatric disorders
  • serious renal and hepatic damage
  • coagulation disorders
  • serious cardiac and respiratory disorderders
  • rejection of spinal anesthesia

研究组 & 干预措施

alprazolam

Experimental

干预措施: Alprazolam tablet (Drug)

hydroxyzine

Experimental

干预措施: Hydroxyzine Hydrochloride (Drug)

control

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

preopartive anxiety

时间窗: 1 hour later orally admition of drugs

Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30)

次要结局

  • Patient satisfaction(24 hours after surgery)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

mesure gul nihan ozden

Principal investigator

Istanbul Medeniyet University

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