Trial Outcomes & Findings for Multimodal Versus Opioid aNalgesia in carDiAc Surgery (NCT NCT04987372)

Last Updated: 2023-11-08

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

At 48 hours after cardiac surgery

Results posted on

2023-11-08

Participant Flow

Study start on January 21, 2019, primary completion on December 1st, 2021.

Participant milestones

Participant milestones
Measure	Classical Protocol 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 case of break through pain Oxynorm (Oxycodon) 5-10mg 4-6/d PO Post-operative in case of Break through pain	Multimodal Protocol 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 Dexmedetomidine: The use of multimodal painkillers pre, per and postoperative
Overall Study STARTED	50	50
Overall Study COMPLETED	50	46
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Classical Protocol n=50 Participants 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 case of break through pain Oxynorm (Oxycodon) 5-10mg 4-6/d PO Post-operative in case of Break through pain	Multimodal Protocol n=46 Participants 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 Dexmedetomidine: The use of multimodal painkillers pre, per and postoperative	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=46 Participants	0 Participants n=96 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=50 Participants	9 Participants n=46 Participants	27 Participants n=96 Participants
Age, Categorical >=65 years	32 Participants n=50 Participants	37 Participants n=46 Participants	69 Participants n=96 Participants
Age, Continuous	70.2 years STANDARD_DEVIATION 9.4 • n=50 Participants	71.2 years STANDARD_DEVIATION 8.1 • n=46 Participants	70.7 years STANDARD_DEVIATION 8.9 • n=96 Participants
Sex: Female, Male Female	9 Participants n=50 Participants	8 Participants n=46 Participants	17 Participants n=96 Participants
Sex: Female, Male Male	41 Participants n=50 Participants	38 Participants n=46 Participants	79 Participants n=96 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	50 participants n=50 Participants	46 participants n=46 Participants	96 participants n=96 Participants

PRIMARY outcome

Timeframe: At 48 hours after cardiac surgery

Outcome measures

Outcome measures
Measure	Classical Protocol n=50 Participants 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 n=46 Participants 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 Dexmedetomidine: The use of multimodal painkillers pre, per and postoperative
Postoperative Pain After Cardiac Surgery	2.28 units on a scale Standard Deviation 1.906	2.17 units on a scale Standard Deviation 2.039

SECONDARY outcome

Timeframe: At 48 h after surgery

delirium in the direct postoperative phase, by using the ICDSC (Intensive Care Delirium Screening Checklist) score. The ICDSC is score-based (range 0-8) where the ICDSC is positive when any four (or more) symptoms of delirium are present (i.e., altered level of consciousness, inattention, disorientation, hallucinations or delusions, psychomotor activity, inappropriate speech or mood, sleep disturbance or fluctuation of symptoms)

Outcome measures

Outcome measures
Measure	Classical Protocol n=50 Participants 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 n=46 Participants 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 Dexmedetomidine: The use of multimodal painkillers pre, per and postoperative
(ICDSC)Delirium After Stop Sedation by Using Intensive Care Delirium Screening Checklist	0.0 score on a scale Interval 0.0 to 0.0	0.0 score on a scale Interval 0.0 to 0.0

Adverse Events

Classical Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multimodal Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

dr. Harlinde Peperstraete

UZ Ghent

Phone: +3293325185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place