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Multimodal Analgesia Versus Traditional Opiate Based Analgesia

Fudan University logo

Fudan University

Status

Unknown

Conditions

Cardiac Surgery

Treatments

Drug: Lidocaine
Drug: Ketamine
Drug: Tylenol Pill
Drug: Gabapentin
Drug: Tylenol
Drug: Dexmedetomidine
Drug: Gabapentin Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT03521167
MAvsTOBA

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

225 participants in 3 patient groups, including a placebo group

T
No Intervention group
Description:
traditional opioid based regimen
MD
Active Comparator group
Description:
multimodal group with dexmedetomidine
Treatment:
Drug: Tylenol
Drug: Dexmedetomidine
Drug: Gabapentin Pill
Drug: Tylenol Pill
Drug: Lidocaine
Drug: Ketamine
Drug: Gabapentin
M
Placebo Comparator group
Description:
multimodal with saline placebo
Treatment:
Drug: Tylenol
Drug: Gabapentin Pill
Drug: Tylenol Pill
Drug: Lidocaine
Drug: Ketamine
Drug: Gabapentin

Trial contacts and locations

0

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Central trial contact

Kefang Guo, PHD

Data sourced from clinicaltrials.gov

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