Phase 4
N=100
Multimodal Versus Opioid aNalgesia in carDiAc Surgery
Postoperative Pain · Postoperative Delirium
Bottom Line
View on ClinicalTrials.gov: NCT04987372 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Postoperative Pain After Cardiac Surgery — 2.28; 2.17 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Ghent
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain After Cardiac Surgery |
2.28; 2.17 | — |
| SECONDARY (ICDSC)Delirium After Stop Sedation by Using Intensive Care Delirium Screening Checklist |
0.0; 0.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04987372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.