Clinical trial • Cardiology|Other

methadone hydrochloride for Postoperative pain after cardiac surgery (coronary artery bypass grafting and/or valve surgery)

Clinical trial of methadone hydrochloride for Postoperative pain after cardiac surgery (coronary artery bypass grafting and/or valve surgery).

Overview

Trial Therapeutic Area: Cardiology|Other
Trial Disease: Postoperative pain after cardiac surgery (coronary artery bypass grafting and/or valve surgery)
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 16-12-2024
First CTIS Authorization Date: 10-01-2025

Trial design

Randomised, usual care comparator: fentanyl 15 mcg/kg at induction of anesthesia + oxycodone 0.2 mg/kg approximately 30 minutes prior to end of surgery. placebo product (isotonic sodium chloride) is listed as placebo comparator (intravenous injection).-controlled trial across 1 site in Denmark.

Randomised: Yes
Comparator: Usual care comparator: fentanyl 15 mcg/kg at induction of anesthesia + oxycodone 0.2 mg/kg approximately 30 minutes prior to end of surgery. Placebo product (isotonic sodium chloride) is listed as placebo comparator (intravenous injection).
Target Sample Size: 220
Trial Duration For Participant: 90

Eligibility

Recruits 220 Vulnerable populations not selected. Individuals unable to provide informed consent are excluded ("Inability to provide informed consent"). Consent is required from participants; subject information and informed consent forms for adults are provided..

Pregnancy Exclusion: 2) Pregnancy or currently breastfeeding
Vulnerable Population: Vulnerable populations not selected. Individuals unable to provide informed consent are excluded ("Inability to provide informed consent"). Consent is required from participants; subject information and informed consent forms for adults are provided.

Inclusion criteria

{"criterion_text":"- 1) Age ≥ 18 years\n- 2) Scheduled for CABG and/or valve surgery."}

Exclusion criteria

{"criterion_text":"- 1) Acute surgery\n- 2) Pregnancy or currently breastfeeding\n- 3) Know elongated Qt syndrome\n- 4) Prolonged QT‐interval assessed by electrocardiogram > 500ms\n- 5) Existing treatment with methadone\n- 6) Preadmission treatment with opioids\n- 7) Allergy to methadone\n- 8) Inability to provide informed consent\n- 9) Dialysis There will be no general restrictions on inclusion into other"}

Endpoints

Primary endpoints

{"endpoint_text":"- The primary endpoint will be cumulated intravenous morphineequivalent consumption within 48 hours from surgery","definition_or_measurement_approach":"Cumulative intravenous morphine-equivalent consumption measured within 48 hours from surgery."}

Secondary endpoints

{"endpoint_text":"- Intraoperative need for inotropes and vasopressors","definition_or_measurement_approach":""}
{"endpoint_text":"- Pain intensity assessed by the Numeric Rating Scale (NRS) at rest and at cough.","definition_or_measurement_approach":"Pain intensity measured using the Numeric Rating Scale (NRS) at rest and during cough."}
{"endpoint_text":"- Pain intensity assessed by the Numeric Rating Scale (NRS) during physiotherapeutic testing","definition_or_measurement_approach":"Pain intensity measured using the Numeric Rating Scale (NRS) during physiotherapeutic testing."}
{"endpoint_text":"- Time from arrival in CICU until patient extubating and mobilization.","definition_or_measurement_approach":""}
{"endpoint_text":"- CICU Length of stay (time from arrival at CICU until booking of transfer to the ward)","definition_or_measurement_approach":""}
{"endpoint_text":"- Days until bowel function (movement, Flatus, stool)","definition_or_measurement_approach":""}
{"endpoint_text":"- Quality of Recovery 1516 at postoperative day 0, 1, 2, 3, 30 and 90.","definition_or_measurement_approach":"Quality of Recovery measured using QoR-15/16 at specified postoperative days."}
{"endpoint_text":"- Quality of life assessed by the SF-3617 after 90 days.","definition_or_measurement_approach":"Quality of life measured using the SF-36 at 90 days."}
{"endpoint_text":"- Chronic pain assessment at 30 and 90 days after surgery.","definition_or_measurement_approach":""}
{"endpoint_text":"- Time to hospital discharge.","definition_or_measurement_approach":""}
{"endpoint_text":"- 3 months mortality","definition_or_measurement_approach":"Mortality assessed at 3 months (90 days)."}
{"endpoint_text":"- Reported occurrence of postoperative arrythmias","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 220
Recruitment Window Months: 13
Consent Approach: Informed consent is required from adult participants (age ≥18). Subject information and informed consent forms for adults are provided (documents: L1_SIS adults, L1_ICF adults). Individuals unable to provide informed consent are excluded.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 220

Denmark

Earliest CTIS Part Ii Submission Date: 21-11-2024
Latest Decision Or Authorization Date: 10-01-2025
Processing Time Days: 50
Number Of Sites: 1
Number Of Participants: 220

Sites

Site Name: Rigshospitalet
Department Name: cardiothoracic anesthesia
Principal Investigator Name: Mark Soegaard Niegsch
Principal Investigator Email: mark.soegaard.niegsch.01@regionh.dk
Contact Person Name: Mark Soegaard Niegsch
Contact Person Email: mark.soegaard.niegsch.01@regionh.dk

Sponsor

Primary sponsor

Full Name: Rigshospitalet
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Denmark

Third parties

{"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name: METHADONE
Active Substance: methadone hydrochloride
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INJECTION (injection)
Route: Injection
Starting Dose: 0.3 mg/kg administered after induction of anesthesia
Dose Levels: 0.3 mg/kg
Frequency: Single intraoperative dose (after induction)
Maximum Dose: 0.3 mg/kg

Investigational Product Name: Fentanyl "B. Braun" 50 mikrogram/ml injektionsvätska, lösning
Active Substance: fentanyl citrate
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INJECTION (injection)
Route: Injection
Starting Dose: 15 mcg/kg at induction of anesthesia
Dose Levels: 15 mcg/kg
Frequency: At induction of anesthesia
Maximum Dose: 1 mg/kg (product listing shows maxTotalDoseAmount: 1 mg/Kg)

Investigational Product Name: Lindoxa, injektions-/infusionsvæske, opløsning
Active Substance: oxycodone hydrochloride
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INJECTION/INFUSION (injection/infusion)
Route: Injection/Infusion
Starting Dose: 0.2 mg/kg approximately 30 minutes prior to end of surgery
Dose Levels: 0.2 mg/kg
Frequency: Single perioperative dose (~30 minutes before end of surgery)
Maximum Dose: 12 mg/kg (product listing shows maxTotalDoseAmount: 12 mg/Kg)

Investigational Product Name: Natriumklorid isotonisk "SAD", injektionsvæske, opløsning
Active Substance: sodium chloride
Modality: Other
Routes Of Administration: SOLUTION FOR INJECTION (injection)
Route: Injection
Starting Dose: Not applicable (placebo); product listing max daily amount 10 ml
Dose Levels: up to 10 ml
Frequency: As administered (placebo)
Maximum Dose: 10 ml

Combination Treatment: Yes

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