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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

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.


Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: Ketamine Drug: Lidocaine Drug: Dexmedetomidine Drug: Gabapentin Drug: Tylenol Drug: Gabapentin Pill Drug: Tylenol Pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: T
traditional opioid based regimen
Active Comparator: MD
multimodal group with dexmedetomidine
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)

Placebo Comparator: M
multimodal with saline placebo
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: 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)




Primary Outcome Measures :
  1. Evaluation of analgesic effect [ Time Frame: Within 3 months after surgery ]
    Evaluation of analgesic effect by Visual Analogue Scale


Secondary Outcome Measures :
  1. Additional opioid consumption [ Time Frame: Within 3 days after operation ]
    assessed by daily sufentanil PCIA dose

  2. postoperative delirium [ Time Frame: Within 3 days after operation ]
    evaluated by CAM-ICU criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521167


Contacts
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Contact: Kefang Guo, PHD +86-13817706936 drguokefang@foxmail.com

Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Lin Jin, PHD Fudan University
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03521167    
Other Study ID Numbers: MAvsTOBA
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Lidocaine
Dexmedetomidine
Ketamine
Gabapentin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Anticonvulsants