Multimodal Analgesia Versus Traditional Opiate Based Analgesia

Cardiac Surgery Clinical Trial

Official title:

Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03521167
• Other study ID #: MAvsTOBA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Kefang Guo, PHD
• Phone: +86-13817706936
• Email: drguokefang[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: December 30, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.
• Lidocaine
Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
• Dexmedetomidine
Intraoperatively use. start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
• Gabapentin
Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness
• Tylenol
Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg
• 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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of analgesic effect	Evaluation of analgesic effect by Visual Analogue Scale	Within 3 months after surgery
Secondary	Additional opioid consumption	assessed by daily sufentanil PCIA dose	Within 3 days after operation
Secondary	postoperative delirium	evaluated by CAM-ICU criteria	Within 3 days after operation