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临床试验/NCT01365195
NCT01365195终止4 期

Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年5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
终止
入组人数
21
试验地点
1
主要终点
Number of Participants With Opioid Consumption

研究概览

简要总结

The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

详细描述

Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

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 80 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

Control

Placebo Comparator

Loading and Infusion:

Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate

干预措施: Ketamine high-dose (Drug)

Control

Placebo Comparator

Loading and Infusion:

Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate

干预措施: Ketamine low-dose (Drug)

Ketamine low-dose

Active Comparator

Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

干预措施: Placebo (Drug)

Ketamine low-dose

Active Comparator

Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

干预措施: Ketamine high-dose (Drug)

Ketamine high-dose

Active Comparator

Loading: 1 mg/Kg Infusion: 10 mcg/kg/min

干预措施: Placebo (Drug)

Ketamine high-dose

Active Comparator

Loading: 1 mg/Kg Infusion: 10 mcg/kg/min

干预措施: Ketamine low-dose (Drug)

结局指标

主要结局

Number of Participants With Opioid Consumption

时间窗: 1 day

Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts

次要结局

  • Participants With Nausea and Vomiting at PACU(1 day)
  • Postoperative Pain(one day)

研究者

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

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

研究点 (1)

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