Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia.
Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events.
The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-64
- surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
- ASA physical status classification I, II, III
- Body Mass Index >35kg/m2
- Fluent in English
Exclusion Criteria:
- History of allergy to protocol medications
- History of chronic opioid use
- Pregnant patients
- Drop out: Conversion to an open surgical route, patient or surgeon request.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Group K (Ketamine)
Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
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Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
其他名称:
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安慰剂比较:Group P (Placebo)
Group P (placebo) will receive the same amount of saline.
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Group P (placebo) will receive the same amount of saline.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of Recovery 40
大体时间:24 hours
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Scores on QOR (quality of recovery) 40 questionnaire.
The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Postoperative Opioid Consumption
大体时间:24 hours
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Total number of opioids (morphine equivalents) consumed 24 hours after surgery
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24 hours
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Postoperative Pain Scores
大体时间:24 hours
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Participants pain scores will be recorded at 24 hours after surgery.
Pain scores range from 0 (no pain) to 10 (worst pain imaginable).
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24 hours
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Length of Hospital Stay
大体时间:Up to 2 weeks
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The subjects length of hospital stay will be recorded.
Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks..
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Up to 2 weeks
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合作者和调查者
调查人员
- 首席研究员:Meltem Yilmaz, MD、Northwestern University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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