Multimodal Analgesia Versus Traditional Opiate Based Analgesia
Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome
Pain after cardiac surgery can be moderate to severe with incisions to the sternum and lower extremities, and also the placement of chest tubes. Postoperative pain may contribute to delirium, stress, myocardial oxygen demand supply imbalance, etc. Traditionally postoperative pain management after cardiac surgery has been based on opiate analgesics. However, opiates have many deleterious side effects including nausea/vomiting, ileus, bladder dysfunction, and respiratory depression, which substantially influence patient recovery and may delay discharge after surgery.
The current study is designed to evaluate if an opiate sparing multimodal regimen of tylenol, gabapentin, ketamine, lidocaine and dexmedetomidine provided better analgesic effect (pain score, postoperative PCA opioid dose), less side effects (PONV) and improved cardiac surgery outcome (delirium, a-fib, AKI, dysglycemia) compared to a traditional fentanyl and hydromorphine regimen after cardiac surgery. Additionally, it aims to investigate if the benefit of multimodal regimen is achieved by combination of all drugs or all drugs except dexmedetomodine by introducing third group of study patients who will be randomized to all interventions except saline placebo instead of dexmedetomodine infusion.
研究概览
地位
条件
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
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:
- ASA II-III Grade
- BMI 18-31kg/m2
- Adult patients presenting for on-pump cardiac surgery through median sternotomy
Exclusion Criteria:
- Cardiac surgery without sternotomy
- emergency surgery
- h/o allergy to any of the medications in the research protocol
- hepatic disease with elevated liver enzymes (preoperative SGPT and SGOT elevated to 1.5 times maximum normal value)
- pregnancy
- unable to give consent
- preoperative mental disorders
学习计划
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:T
traditional opioid based regimen
|
|
有源比较器:MD
multimodal group with dexmedetomidine
|
Intraoperatively use. 0.5 mg/kg with induction bolus, followed by 5mcg/kg/min infusion after induction. Continue up to 1 hour prior to extubation. maximum total dose 3mg/kg.
Intraoperatively use.
start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
Intraoperatively use.
start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
Postoperatively use.
300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness
Postoperatively use.
1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg
Pre-operatively use.
300mg PO up to 1 hour before OR time Reduce to 100 mg PO in patients >65y or with GFR < 50 Consider dose reduction in patients with sleep apnea
Pre-operatively use.
1000 mg PO up to 1 hour before OR time Reduce to 650 mg PO if <70kg Don't use if h/o liver disease or anticipated liver injury (right heart failure, pulmonary hypertension, etc leading to systemic venous congestion)
|
安慰剂比较:M
multimodal with saline placebo
|
Intraoperatively use. 0.5 mg/kg with induction bolus, followed by 5mcg/kg/min infusion after induction. Continue up to 1 hour prior to extubation. maximum total dose 3mg/kg.
Intraoperatively use.
start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
Postoperatively use.
300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness
Postoperatively use.
1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg
Pre-operatively use.
300mg PO up to 1 hour before OR time Reduce to 100 mg PO in patients >65y or with GFR < 50 Consider dose reduction in patients with sleep apnea
Pre-operatively use.
1000 mg PO up to 1 hour before OR time Reduce to 650 mg PO if <70kg Don't use if h/o liver disease or anticipated liver injury (right heart failure, pulmonary hypertension, etc leading to systemic venous congestion)
|
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 |
---|---|---|
Evaluation of analgesic effect
大体时间:Within 3 months after surgery
|
Evaluation of analgesic effect by Visual Analogue Scale
|
Within 3 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Additional opioid consumption
大体时间:Within 3 days after operation
|
assessed by daily sufentanil PCIA dose
|
Within 3 days after operation
|
postoperative delirium
大体时间:Within 3 days after operation
|
evaluated by CAM-ICU criteria
|
Within 3 days after operation
|
合作者和调查者
调查人员
- 首席研究员:Lin Jin, PHD、Fudan University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MAvsTOBA
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