NCT00480142Unknown4 期
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study
Kaplan Medical Center0 个研究点目标入组 100 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
研究概览
简要总结
A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).
CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local ethic committee approval
- •Written informed consent
- •ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH
排除标准
- •Difficulty in communication
- •Allergy to oxycodone and/or morphine
- •Allergy to local anesthetic
- •History of alcohol and substance abuse
- •Treated depression
- •Chronic use of opioid or tramadol or NSAIDS
- •Pregnancy
- •Obstructive sleep apnea
- •Anticipated fiber optic intubation
- •Severe hepatic or renal impairment
- •Weight <50 kg or > 100 kg
- •Conversion to laparotomy
- •Patient extubated in PACU.
- •Any prior abdominal surgery
研究者
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