Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants (ARNRD)
2020年3月18日 更新者：Jung Min Koo
Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants
Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Both of these agents are short acting, can be infused with targeted concentrations, excreted shortly from the body with stable hemodynamics.
Remifentanil, when infused for more than 2 hours, causes hyperalgesia to increase the amount of pain postoperatively as well as the amount of opioid analgesics. However, dexmedetomidine does not cause hyperalgesia and is known to have an opioid -sparing effect. In our center.
In this study, we aim to compare the effects of remifentanil and dexmedetomidine on postoperative pain in patients undergoing Nuss procedure, which is a very painful operation on the chest wall.
研究概览
研究类型
介入性
注册 (预期的)
62
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国
- Jung Min Koo
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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
20年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults aged >20
- Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
- American Society of Anesthesiologists classification I ~ III
Exclusion Criteria:
- Drug abuse history
- Chronic pain in need of continuous opioid analgesics administration
- History of psychiatric diseases
- Preoperative bradycardia (heart rate < 50/min) or arrythmia
- Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
- Moderate liver or kidney dysfunction
- Pregnant or breast feeding women
- Hypersensitivity to the study drugs
- Patients who do not agree to participate
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：Remifentanil group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted Minimal Alveolar Concentration (MAC).
As explained above, remifentanil is infused with Target Controlled Infusion pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia.
Remifentanil is usually infused with the effect site concentration of 2.0 to 6.0 ng/ml during general anesthesia.
If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased.
At the end of the surgery when skin closure starts, remifentanil infusion will be stopped.
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Comparing effects of remifentanil versus dexmedetomidine
其他名称：
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有源比较器：Dexmedetomidine group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted MAC (Minimal Alveolar Concentration).
As explained above, dexmedetomidine is infused with syringe pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia.
Dexmedetomidine is loaded for 10 minutes in 1mcg/kg, and then infusion rate is set between 0.4 to 0.6mcg/kg/hour for this study.
If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased.
At the end of the surgery when skin closure starts, dexmedetomidine infusion will be stopped.
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Comparing effects of remifentanil versus dexmedetomidine
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 |
|---|---|---|
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Visual Analogue Scale
大体时间：Between 1~6 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 1~6 hours postoperatively.
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Visual Analogue Scale
大体时间：Between 6~12 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 6~12 hours postoperatively.
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Visual Analogue Scale
大体时间：Between 12~24 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 12~24 hours postoperatively.
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Visual Analogue Scale
大体时间：Between 24~48 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 24~48 hours postoperatively.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Amount of postoperative intravenous patient controlled analgesics (PCA) used
大体时间：At 60 minutes after the end of surgery
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At 60 minutes after the end of surgery
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Amount of fentanyl used postoperatively at the recovery unit
大体时间：At 60 minutes after the end of surgery
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Amount in micgrograms per wegith in kilograms (migrogram/kilogram)
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At 60 minutes after the end of surgery
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Time needed for postoperative rescue opioid analgesics
大体时间：At 60 minutes after the end of surgery
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At 60 minutes after the end of surgery
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Amount of remifentanil or dexmedetomidine used intraoperatively
大体时间：Immediately at the end of the surgery
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Immediately at the end of the surgery
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Intraoperative hemodynamic change: Systolic blood pressure
大体时间：1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: Diastolic blood pressure
大体时间：1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: mean blood pressure
大体时间：1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: heart rate
大体时间：30 minutes after the induction of anesthesia
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30 minutes after the induction of anesthesia
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Intraoperative hemodynamic change: mean blood pressure
大体时间：At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: heart rate
大体时间：At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: Systolic blood pressure
大体时间：At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: Diastolic blood pressure
大体时间：At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia
大体时间：Intraoperatively
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Intraoperatively
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Postoperative complications
大体时间：Between 1~6 hours postoperatively
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Number of events that happened to the patient: e.g.
Yes or No, and how many times.
Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
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Between 1~6 hours postoperatively
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Postoperative complications
大体时间：Between 12~24 hours postoperatively
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Number of events that happened to the patient: e.g.
Yes or No, and how many times.
Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
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Between 12~24 hours postoperatively
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Postoperative complications
大体时间：Between 24~48 hours postoperatively
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Number of events that happened to the patient: e.g.
Yes or No, and how many times.
Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
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Between 24~48 hours postoperatively
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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。
赞助
调查人员
- 首席研究员：Jung Min Koo, M.D、Data recruitment
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)
2019年9月2日
初级完成 (预期的)
2021年2月21日
研究完成 (预期的)
2021年2月28日
研究注册日期
首次提交
2019年8月20日
首先提交符合 QC 标准的
2019年8月27日
首次发布 (实际的)
2019年8月29日
研究记录更新
最后更新发布 (实际的)
2020年3月20日
上次提交的符合 QC 标准的更新
2020年3月18日
最后验证
2020年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.