Post Craniotomy Analgesia Safety Monitoring With ET CO2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Respiratory Depression
研究概览
简要总结
This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.
详细描述
See brief summary
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
- None
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
- •Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.
排除标准
- •pregnant women
- •patients with post operative neurological changes
- •patients who remain intubated post-operatively
- •patients who require the use of concomitant administration of sedatives
- •patients who are unable to initiate a PCA bolus
- •patients who are unable to communicate verbally
- •patients who are allergic to fentanyl
- •patients who have a history of narcotic abuse
- •patients who have a history of chronic pain requiring opioids
- •patients who have been in any investigational drug trial within 1 month of the treatment day
- •patients who have chronic respiratory insufficiency
研究组 & 干预措施
Pro re nata (PRN) fentanyl
A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
干预措施: Fentanyl (Drug)
Intravenous Patient-controlled Analgesia (IVPCA) fentanyl
Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Respiratory Depression
时间窗: Up to 24 hours postoperatively.
Defined by maximal End Tidal CO2 (mmHg)
次要结局
- Hypoxia(up to 24 hours postoperatively)