跳至主要内容
临床试验/NCT02224170
NCT02224170终止不适用

Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
QoR-40 score

研究概览

简要总结

The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy

研究设计

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

入排标准

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

入选标准

  • ASA I-II patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy due to gallbladder polyp or asymptomatic gallstones without cholecystitis

排除标准

  • Steroid therapy or immunocompromised patients
  • Diabetes mellitus
  • Allergy to lidocaine or dexamethasone
  • Severe renal dysfunction (serum creatinine more than 1.6mg/dl)
  • Severe liver disease ( liver enzymes more than two times normal values)
  • History of atrioventricular block
  • Have a difficulty in understanding QoR-40 (40-item quality-of-recovery scoring system) or Korean language
  • History of physicologic disease

研究组 & 干预措施

Lidocaine group

Experimental

干预措施: Lidocaine (Drug)

Dexamethasone group

Active Comparator

干预措施: Dexamethasone (Drug)

结局指标

主要结局

QoR-40 score

时间窗: from baseline to 3 hours on the day after surgery

40-item quality-of-recovery scoring system

次要结局

  • Incidence and severity of postoperative nausea and vomiting(from baseline to 3 hours on the day after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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