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临床试验/NCT01542697
NCT01542697Unknown4 期

Phase IV Recruiting

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
number of analgesic request

研究概览

简要总结

intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.

详细描述

Sixty patients undergoing laparoscopic cholecystectomy belonging to American Society of Anaesthesiologist (I-II) of age 18-65 yrs will be enrolled.Group one (n=30) will receive 1.5 gm magnesium sulphate diluted in 3ml of normal saline and group 2 (n=30) will receive 5 ml of NS.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Magnesium sulphate

Active Comparator

intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline at the end of surgery before closure

干预措施: intraperitoneal nebulisation of magnesium sulphate (Drug)

normal saline

Placebo Comparator

intraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure

干预措施: intraperitoneal nebulisation of magnesium sulphate (Drug)

结局指标

主要结局

number of analgesic request

时间窗: 24 hour

time to first analgesic request is taken as duration of effective analgesia number of analgesic request in first 24 hours were also counted

次要结局

  • VAS score(first complaint of pain, 6 hrs, 12 hrs, 24 hrs)
  • nausea and vomiting(24 hrs)
  • respiratory rate(24 hrs)
  • sedation(24hrs)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sujata niroula

junior resident

B.P. Koirala Institute of Health Sciences

研究点 (1)

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