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临床试验/NCT01777100
NCT01777100已完成4 期

Phase IV Study of Postoperative Analgesic Efficacy and Safety of Anesthesia Induction With Single Dose Sufentanil for Open Abdominal Surgery Under Continuous Remifentanil Anesthesia Versus Total Intravenous Remifentanil Anesthesia

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Morphine consumption through patient controlled analgesia pump

研究概览

简要总结

The appropriate management of postoperative pain is recognized as an important clinical challenge with implications beyond humanitarian issues. Evidence shows that effective postoperative analgesia is associated with physiological benefits to the patient, shortened length of hospital stay and lower rates of in-hospital complications, such as pneumonia, delirium and persistent pain after surgery. However, despite the availability of several analgesic drugs and strategies the prevention and treatment of postoperative pain is often suboptimal. Remifentanil is a potent short acting opioid commonly used in continuous infusion for anesthesia for several surgical procedures. Remifentanil has been extensively advocated as a means to provide quick patient awakening in the immediate postoperative period with a very low risk of respiratory depression. Yet it does not provide residual analgesia and postoperative pain is a major concern. In order to overcome this limitation, practicing anesthesiologists frequently give patients a single dose of Sufentanil, a long acting opioid, during the induction of anesthesia where Remifentanil will be used in continuous infusion. However the effectiveness of this strategy still lacks evidence from controlled clinical trials.

详细描述

We propose the current randomized clinical trial to assess the analgesic effectiveness of Sufentanil administered as a single dose during the induction of anesthesia for the management of postoperative pain in patients undergoing open abdominal surgery performed with continuous infusion of Remifentanil.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Physical status (American Society of Anesthesiologists) 1, 2 or 3
  • Age 18 years and older
  • Patients selected for open Abdominal surgery under general total intravenous anesthesia

排除标准

  • Physical status (American Society of Anesthesiologists) 4
  • Patients undergoing other anesthesia technic (subarachnoid, epidural, nerve block, etc)
  • History of anaphylactic reaction after use of tramadol, dipyrone, propofol, rocuronium, dexamethasone, sufentanil, remifentanil or morphine
  • Chronic uso of drugs that are associated with major increases in the activity of P450 isozymes (Carbamazepine, phenobarbital, rifampin, tobacco, phenytoin, Hypericum perforatum)
  • Previous History of Drug addiction
  • alcoholism

研究组 & 干预措施

sufentanil

Experimental

Anesthetic induction with IV sufentanil at 0.5 mcg.kg-1 and analgesic maintenance with IV remifentanil at 0.1 to 0.3 mcg.kg-1.min-1 on demand target-controlled infusion

干预措施: Sufentanil (Drug)

结局指标

主要结局

Morphine consumption through patient controlled analgesia pump

时间窗: 24 hours after surgery

次要结局

  • Morphine consumption through patient controlled analgesia pump(12 hours after surgery)

研究者

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

Fernanda Bono Fukushima

MD, PhD

University of Sao Paulo

研究点 (1)

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