Effect of pre-operative single dose Levetiracetam on anxiety associated with laparoscopic cholecystectomy: a randomized, double blinded, placebo controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- level of anxiety in terms of visual analogue score before surgery
研究概览
简要总结
Back ground:
Preoperative anxiety has been described as a subjective feeling of apprehension, fear and nervousness. Levetiracetam is a novel anti epileptic drug and number of studies have shown that it also has anxiolysis property.
Aims and Objectives:
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To asses whether Levetiracetam decreases anxiety in terms of VAS in pre operative period
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To find out whether the use of Levetiracetam causes sedation
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To observe incidence of side effect if any
Material and Methods:
102 patients with physical status ASA I and II, who are posted for elective laparoscopic cholecystecymy will be divided into three groups two receive either tablet Levetiracetam 500 mg or placebo 4 hours before surgery. Pre operative anxiety will be assessed using visual analogue score before giving the study drug, at pre operative holding area and on operation theater table before induction of surgery. Sedation and incidence of side effect will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with physical status ASA I and II, are scheduled for elective laparoscopic cholecystectomy.
排除标准
- •Age< 18 years or >70years
- •body mass index (BMI) <19 and >35 kg/m2
- •known sensitivity to study drugs
- •inability to tolerate oral medication and understand the anxiety (VAS) score,
- •has cardiac problem, renal or hepatic dysfunction, respiratory disease or any psychiatric problem.
- •on chronic pain medication, anticonvulsant or antidepressant.
- •pregnant patients
- •Patients are not giving consent to get enrolled in the study.
结局指标
主要结局
level of anxiety in terms of visual analogue score before surgery
时间窗: level of anxiety in terms of visual analogue score will be assessed before giving the study drug, at pre operative holding area before entering to operation theater, at operation theater just before administering anaesthesia
次要结局
- sedation level(just before giving the study drug, at pre operative holding area before entering to operation theater, on operation theater table just before induction of anesthesia)