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Multimodal Analgesia Versus Traditional Opiate Based Analgesia

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ClinicalTrials.gov Identifier: NCT03521167
Recruitment Status : Unknown
Verified April 2018 by Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date May 11, 2018
Estimated Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Evaluation of analgesic effect [ Time Frame: Within 3 months after surgery ]
Evaluation of analgesic effect by Visual Analogue Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Additional opioid consumption [ Time Frame: Within 3 days after operation ]
    assessed by daily sufentanil PCIA dose
  • postoperative delirium [ Time Frame: Within 3 days after operation ]
    evaluated by CAM-ICU criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Analgesia Versus Traditional Opiate Based Analgesia
Official Title  ICMJE Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Surgery
Intervention  ICMJE
  • Drug: Ketamine

    Intraoperatively use. 0.5 mg/kg with induction bolus, followed by 5mcg/kg/min infusion after induction.

    Continue up to 1 hour prior to extubation. maximum total dose 3mg/kg.

  • Drug: Lidocaine
    Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
  • Drug: Dexmedetomidine
    Intraoperatively use. start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
  • Drug: Gabapentin
    Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness
  • Drug: Tylenol
    Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg
  • Drug: Gabapentin Pill
    Pre-operatively use. 300mg PO up to 1 hour before OR time Reduce to 100 mg PO in patients >65y or with GFR < 50 Consider dose reduction in patients with sleep apnea
  • Drug: Tylenol Pill
    Pre-operatively use. 1000 mg PO up to 1 hour before OR time Reduce to 650 mg PO if <70kg Don't use if h/o liver disease or anticipated liver injury (right heart failure, pulmonary hypertension, etc leading to systemic venous congestion)
Study Arms  ICMJE
  • No Intervention: T
    traditional opioid based regimen
  • Active Comparator: MD
    multimodal group with dexmedetomidine
    Interventions:
    • Drug: Ketamine
    • Drug: Lidocaine
    • Drug: Dexmedetomidine
    • Drug: Gabapentin
    • Drug: Tylenol
    • Drug: Gabapentin Pill
    • Drug: Tylenol Pill
  • Placebo Comparator: M
    multimodal with saline placebo
    Interventions:
    • Drug: Ketamine
    • Drug: Lidocaine
    • Drug: Gabapentin
    • Drug: Tylenol
    • Drug: Gabapentin Pill
    • Drug: Tylenol Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521167
Other Study ID Numbers  ICMJE MAvsTOBA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lin Jin, PHD Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP