Comparison of pain and comfort in patients following cardiac surgery: opioid-morphine managed vs multimodal pain-management. - MONDAY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000515-84-BE

Enrollment

120

Registered

2019-07-15

Start date

2019-07-16

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery. MedDRA version: 20.0 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Dexdor 100 microgram/ml concentraat voor oplossing voor infusie Product Name: dexmedetomidine Pharmaceutical Form: Solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 11

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients undergoing first time cardiac surgery by median sternotomy - elective surgery or semi-urgent: there needs to be time to provide 8 hours before surgery the intake of pregabalin - > or = 18 years - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - urgent surgery - pregnancy and lactation - hypersensitivity to any of the study medication - in case of direct postoperative revision the patient is NOT excluded

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare "Fentanyl-Tramadol-Paracetamol-Oxycodon" regimen to a multimodal painmanagement "pregabalin-minimal fentanyl-ketamine-lidocain-dexmedetomidine-paracetamol" to determin which therapy provides the most comfort, the fastest extubation time, the least pain and the least delirium.;Secondary Objective: Not Applicable.;Primary end point(s): The primary endpoint of this study is postoperative pain (at rest, when coughing and at movement) after cardiac surgery. Pain is measured by a NRS-scale if the patient is awake, and by the critical-care pain observation tool (CPOT) in the sedated patient.;Timepoint(s) of evaluation of this end point: At 8h-16h-24h-32h-40h and 48h after cardiac surgery.	—

Measure

Time frame

Main Objective: To compare "Fentanyl-Tramadol-Paracetamol-Oxycodon" regimen to a multimodal painmanagement "pregabalin-minimal fentanyl-ketamine-lidocain-dexmedetomidine-paracetamol" to determin which therapy provides the most comfort, the fastest extubation time, the least pain and the least delirium.;Secondary Objective: Not Applicable.;Primary end point(s): The primary endpoint of this study is postoperative pain (at rest, when coughing and at movement) after cardiac surgery. Pain is measured by a NRS-scale if the patient is awake, and by the critical-care pain observation tool (CPOT) in the sedated patient.;Timepoint(s) of evaluation of this end point: At 8h-16h-24h-32h-40h and 48h after cardiac surgery.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints include delirium in the direct postoperative phase measured by the ICDSC-score. Also included in the secondary endpoints are: time till extubation, length of hospital stay, length of stay at the ICU department and total comnsumption of pain medication registered in mg/kg.;Timepoint(s) of evaluation of this end point: - time till extubation - length of ICU stay and in general length of hospital stay	—

Measure

Time frame

Secondary end point(s): Secondary endpoints include delirium in the direct postoperative phase measured by the ICDSC-score. Also included in the secondary endpoints are: time till extubation, length of hospital stay, length of stay at the ICU department and total comnsumption of pain medication registered in mg/kg.;Timepoint(s) of evaluation of this end point: - time till extubation - length of ICU stay and in general length of hospital stay

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Countries

Belgium

Contacts

Public ContactHIRUZ CTU

Ghent University Hospital

hiruz.CTU@uzgent.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026