Multimodal Versus Opioid aNalgesia in carDiAc Surgery

NCT04987372 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2019-000515-84
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To compare standard "Fentanyl - Tramadol - Paracetamol - Oxycodone" regimen to a multimodal painmanagement "pregabalin- minimal fentanyl-ketamine-lidocain-dexmedetomidine- paracetamol" to determine which therapy provides the most comfort, the fastest extubation time, the least pain and the least delirium.

Conditions

Postoperative Pain; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain After Cardiac Surgery

  By using a NRS scale postoperative pain (at rest) at 48hours after cardiac surgery In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . Zero usually represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.

  At 48 hours after cardiac surgery

Secondary Outcomes (1)

• (ICDSC)Delirium After Stop Sedation by Using Intensive Care Delirium Screening Checklist

  At 48 h after surgery

Study Arms (2)

Classical protocol

NO INTERVENTION

Fentanyl Max. 15µg/kg IV Per-operative Ultiva (Remifentanyl) 0.02-0.1µg/kg/h IV Post-operative Paracetamol 4x1g /24h IV Post-operative Tradonal (Tramadol) 100mg IV 4/d IV Post-operative in cas of break through pain Oxynorm (Oxycodon) 5-10mg 4-6/d PO Post-operative in case of Break through pain

Multimodal protocol

ACTIVE COMPARATOR

Lyrica (Pregabalin) 75mg PO 2 hours before the operation Dexdor (Dexmedetomidine) 0.8µg/kg/h IV Per-operative / Post-operative Ketalar (Ketamine) Bolus (0.5mg/kg) + 0.3mg/kg/h IV Per-operative until stop propofol Linisol (Lidocain) Bolus (1.5mg/kg) + 1.3mg/kg/h IV Per-operatiive until 12h post-op Magnesium Sulphate Induction (25mg/kg) + 25mg/kg weaning ECC IV Per-operative Fentanyl 2.5µg/kg IV Per-operative Paracetamol 4x1g /24u IV Post-operative Tradonal (Tramadol) 100mg IV 4/d IV Post-operative in case of Break through pain Oxynorm (Oxycodon) 5-10mg 4-6/d PO Post-operative in case of Break through pain

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

The use of multimodal painkillers pre, per and postoperative

Also known as: pregabaline, ketamine, lidocaine, magnesium sulfate

Multimodal protocol

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing first time cardiac surgery by median sternotomy
• Elective surgery or semi-urgent: there needs to be time to provide 1 hour before surgery the intake of pregabalin
• ≥ 18 years for men
• Women who are in menopause
• Possibility to communicate with the patient to score pain and comfort
• Signed Informed Consent, signed by subject able and willing to provide written informed consent for study participation

You may not qualify if:

• Urgent surgery
• Women who are in premenopause
• Hypersensitivity to any of the study medication
• In case of direct postoperative revision the patient is NOT excluded.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium

Interventions

Dexmedetomidine; Ketamine; Lidocaine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: dr. Harlinde Peperstraete
• Organization: UZ Ghent

harlinde.peperstraete@uzgent.be

+3293325185

Study Officials

• Harlinde Peperstraete, MD

  UZ Gent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 3, 2021
• Study Start: January 21, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 3, 2021
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)