Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)
2021年11月13日 更新者：Greta Kasputytė、Lithuanian University of Health Sciences
The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery.
Ketamine is an old general anaesthetic.
Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.
研究概览
详细说明
Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment.
New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects.
One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine.
To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched.
The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.
研究类型
介入性
注册 (预期的)
64
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- II or III The American Society of Anesthesiologists (ASA) physical status
- age > 18 years
- bariatric surgery with general remifentanil anesthesia
Exclusion Criteria:
- anamnesis of using opioids for the treatment of chronic pain
- opioid dependence
- younger than 18 years
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Treatment1
0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
其他名称：
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
其他名称：
|
|
有源比较器：Treatment2
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
其他名称：
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
其他名称：
|
|
有源比较器：Treatment3
0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
其他名称：
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
其他名称：
|
|
安慰剂比较：Control
The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
|
Intravenous injection given pre-incisional in the operating room.
其他名称：
|
|
有源比较器：Treatment4
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
其他名称：
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
其他名称：
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
其他名称：
|
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 |
|---|---|---|
|
Postoperative pain intensity
大体时间：On the first postoperative day
|
Comparison of pain intensity will be recorded in both groups every 15 min in Post Anesthesia Care Unit (PACU) for 2.5 hours.
Postoperative pain was treated with boluses of i.v.
morphine (3 mg) at 3 min.
intervals on request, if pain intensity exceeded the score of 5 according to the Numeric Pain Rating Scale (NPRS) (0-10).
After the transfer of patient's to a regular unit, pain intensity was recorded every 6 hours.
|
On the first postoperative day
|
|
Postoperative morphine requirements
大体时间：On the first postoperative day
|
Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
|
On the first postoperative day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of side effects
大体时间：On the first postoperative day
|
Incidence of side effects will be recorded in both groups on the first postoperative day.
|
On the first postoperative day
|
|
Patients' satisfaction with postoperative analgesia
大体时间：On the second postoperative day
|
Patients' satisfaction with postoperative analgesia will be recorded in both groups on the second postoperative day.The subject could express their level of satisfaction in five possible levels, from "very satisfied" to "very dissatisfied".
|
On the second postoperative day
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Aurika Karbonskienė, MDPhDAssProf、Lithuanian University of Health Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年7月22日
初级完成 (实际的)
2017年3月30日
研究完成 (预期的)
2023年6月6日
研究注册日期
首次提交
2017年12月14日
首先提交符合 QC 标准的
2018年1月1日
首次发布 (实际的)
2018年1月3日
研究记录更新
最后更新发布 (实际的)
2021年11月22日
上次提交的符合 QC 标准的更新
2021年11月13日
最后验证
2021年11月1日
更多信息
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