Multimodal Analgesia Versus Traditional Opiate Based Analgesia
- Conditions
- Cardiac Surgery
- Interventions
- Registration Number
- NCT03521167
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
- ASA II-III Grade
- BMI 18-31kg/m2
- Adult patients presenting for on-pump cardiac surgery through median sternotomy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M Tylenol Pill multimodal with saline placebo MD Gabapentin Pill multimodal group with dexmedetomidine MD Tylenol Pill multimodal group with dexmedetomidine M Gabapentin Pill multimodal with saline placebo M Ketamine multimodal with saline placebo M Lidocaine multimodal with saline placebo M Gabapentin multimodal with saline placebo MD Ketamine multimodal group with dexmedetomidine MD Lidocaine multimodal group with dexmedetomidine MD Dexmedetomidine multimodal group with dexmedetomidine MD Gabapentin multimodal group with dexmedetomidine MD Tylenol multimodal group with dexmedetomidine M Tylenol multimodal with saline placebo
- Primary Outcome Measures
Name Time Method Evaluation of analgesic effect Within 3 months after surgery Evaluation of analgesic effect by Visual Analogue Scale
- Secondary Outcome Measures
Name Time Method Additional opioid consumption Within 3 days after operation assessed by daily sufentanil PCIA dose
postoperative delirium Within 3 days after operation evaluated by CAM-ICU criteria