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临床试验/NCT00848991
NCT00848991已完成3 期

Comparison of Propofol Standard Anesthetic to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery

The Cooper Health System1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
15
试验地点
1
主要终点
The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients.

研究概览

简要总结

Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube.

Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery will provide improved hemodynamic stability.

详细描述

The purpose of this study is to compare the addition of Precedex to a propofol intravenous anesthetic for emergence from anesthesia in patients having craniotomy surgery for brain tumors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •ASA status 1, 2, and 3

排除标准

  • •ASA status 4 and 5 patients
  • •Patients with positive pregnancy tests

研究组 & 干预措施

Propofol

Active Comparator

Propofol for emergence from anesthesia

干预措施: Propofol (Drug)

Precedex

Active Comparator

In the operating room routine anesthesia monitors will be placed and vital signs will be recorded continuously using data collection software. A routine propofol anesthetic will be administered to subjects randomized to the control group or a Precedex infusion with propofol for subjects randomized to the treatment group. Precedex infusion will be started after induction of general anesthesia. Vital signs (SBP, DBP, MAP) will be recorded continuously throughout the surgery. At the end of the case subjects will be extubated and the blinded observer will assess emergence from anesthesia based on hemodynamic stability and tolerance of the endotracheal tube. Videotaping of emergence will be used to assist in the evaluation of emergence of anesthesia and extubation.

干预措施: Precedex (Drug)

结局指标

主要结局

The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients.

时间窗: 4 hours after awaking from surgery

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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