Multimodal Analgesia Versus Traditional Opiate Based Analgesia

• ClinicalTrials.gov Identifier: NCT03521167
• Recruitment Status: Unknown
• First Posted: May 11, 2018
• Last Update Posted: May 11, 2018
• Sponsor: Shanghai Zhongshan Hospital
• Information provided by (Responsible Party): Shanghai Zhongshan Hospital

Tracking Information

• First Submitted Date: April 12, 2018
• First Posted Date: May 11, 2018
• Last Update Posted Date: May 11, 2018
• Estimated Study Start Date: May 1, 2018
• Estimated Primary Completion Date: May 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multimodal Analgesia Versus Traditional Opiate Based Analgesia
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cardiac Surgery

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 27, 2018): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2019
• Estimated Primary Completion Date: May 1, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03521167
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Shanghai Zhongshan Hospital
• Study Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lin Jin, PHD; Fudan University

• PRS Account: Shanghai Zhongshan Hospital
• Verification Date: April 2018