跳至主要内容
临床试验/NCT03521167
NCT03521167Unknown不适用

Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome

Shanghai Zhongshan Hospital0 个研究点目标入组 225 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

multimodal group with dexmedetomidine

干预措施: Dexmedetomidine (Drug)

MD

Active Comparator

multimodal group with dexmedetomidine

干预措施: Gabapentin (Drug)

MD

Active Comparator

multimodal group with dexmedetomidine

干预措施: Ketamine (Drug)

MD

Active Comparator

multimodal group with dexmedetomidine

干预措施: Lidocaine (Drug)

MD

Active Comparator

multimodal group with dexmedetomidine

干预措施: Tylenol (Drug)

MD

Active Comparator

multimodal group with dexmedetomidine

干预措施: Gabapentin Pill (Drug)

MD

Active Comparator

multimodal group with dexmedetomidine

干预措施: Tylenol Pill (Drug)

M

Placebo Comparator

multimodal with saline placebo

干预措施: Ketamine (Drug)

M

Placebo Comparator

multimodal with saline placebo

干预措施: Lidocaine (Drug)

M

Placebo Comparator

multimodal with saline placebo

干预措施: Gabapentin (Drug)

M

Placebo Comparator

multimodal with saline placebo

干预措施: Tylenol (Drug)

M

Placebo Comparator

multimodal with saline placebo

干预措施: Gabapentin Pill (Drug)

M

Placebo Comparator

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)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

相似试验