Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 主要终点
- Evaluation of analgesic effect
研究概览
简要总结
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
- •ASA II-III Grade
- •BMI 18-31kg/m2
- •Adult patients presenting for on-pump cardiac surgery through median sternotomy
排除标准
- •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
研究组 & 干预措施
MD
multimodal group with dexmedetomidine
干预措施: Dexmedetomidine (Drug)
MD
multimodal group with dexmedetomidine
干预措施: Gabapentin (Drug)
MD
multimodal group with dexmedetomidine
干预措施: Ketamine (Drug)
MD
multimodal group with dexmedetomidine
干预措施: Lidocaine (Drug)
MD
multimodal group with dexmedetomidine
干预措施: Tylenol (Drug)
MD
multimodal group with dexmedetomidine
干预措施: Gabapentin Pill (Drug)
MD
multimodal group with dexmedetomidine
干预措施: Tylenol Pill (Drug)
M
multimodal with saline placebo
干预措施: Ketamine (Drug)
M
multimodal with saline placebo
干预措施: Lidocaine (Drug)
M
multimodal with saline placebo
干预措施: Gabapentin (Drug)
M
multimodal with saline placebo
干预措施: Tylenol (Drug)
M
multimodal with saline placebo
干预措施: Gabapentin Pill (Drug)
M
multimodal with saline placebo
干预措施: Tylenol Pill (Drug)
结局指标
主要结局
Evaluation of analgesic effect
时间窗: Within 3 months after surgery
Evaluation of analgesic effect by Visual Analogue Scale
次要结局
- Additional opioid consumption(Within 3 days after operation)
- postoperative delirium(Within 3 days after operation)
