The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction
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
- 否
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
干预措施: Alprazolam tablet (Drug)
hydroxyzine
干预措施: Hydroxyzine Hydrochloride (Drug)
control
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
mesure gul nihan ozden
Principal investigator
Istanbul Medeniyet University
