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Clinical Trials/NCT03521167
NCT03521167
Unknown
Not Applicable

Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome

Shanghai Zhongshan Hospital0 sites225 target enrollmentMay 1, 2018

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
December 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

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)

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