Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome
Overview
- Phase
- Not Applicable
- Intervention
- Dexmedetomidine
- Conditions
- Cardiac Surgery
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 225
- Primary Endpoint
- Evaluation of analgesic effect
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
MD
multimodal group with dexmedetomidine
Intervention: Dexmedetomidine
MD
multimodal group with dexmedetomidine
Intervention: Gabapentin
MD
multimodal group with dexmedetomidine
Intervention: Ketamine
MD
multimodal group with dexmedetomidine
Intervention: Lidocaine
MD
multimodal group with dexmedetomidine
Intervention: Tylenol
MD
multimodal group with dexmedetomidine
Intervention: Gabapentin Pill
MD
multimodal group with dexmedetomidine
Intervention: Tylenol Pill
M
multimodal with saline placebo
Intervention: Ketamine
M
multimodal with saline placebo
Intervention: Lidocaine
M
multimodal with saline placebo
Intervention: Gabapentin
M
multimodal with saline placebo
Intervention: Tylenol
M
multimodal with saline placebo
Intervention: Gabapentin Pill
M
multimodal with saline placebo
Intervention: Tylenol Pill
Outcomes
Primary Outcomes
Evaluation of analgesic effect
Time Frame: Within 3 months after surgery
Evaluation of analgesic effect by Visual Analogue Scale
Secondary Outcomes
- Additional opioid consumption(Within 3 days after operation)
- postoperative delirium(Within 3 days after operation)