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临床试验/NCT01512511
NCT01512511已完成不适用

Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

Ahvaz Jundishapur University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
heart rate

研究概览

简要总结

There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common use, has not compared to N2O sufficiently to disclose which one has minimal "physiological" invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and compared.

研究设计

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

入排标准

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

入选标准

  • developed gallstones
  • candidates for laparoscopic cholecystectomy
  • written informed consent
  • ASA Score = 1&2

排除标准

  • signs and complications of gallstones in admission include acute cholecystitis and suppurative cholangitis
  • complete Inability to move
  • severe physical or mental disorders leading to inability to communicate -Pregnancy and

结局指标

主要结局

heart rate

时间窗: At the start of laparoscopic surgery and Immediately after surgery.

number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.

次要结局

  • Mean arterial pressure(At the start of laparoscopic surgery and Immediately after surgery.)

研究者

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

Mehdi Asgari

Principal Investigator

Ahvaz Jundishapur University of Medical Sciences

研究点 (1)

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