Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain (REFLECT)

St. Antonius Hospital

Status and phase: Completed; Phase 4

Conditions: Fentanyl; Chronic Pain; Remifentanil; Sternotomy

Treatments: Drug: Fentanyl; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02031016

REFLECT study

Details and patient eligibility

About

This study will investigate the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via sternotomy. Secondary quantitative sensory testing is performed to determine thermal and electrical detection and pain threshold and the difference in pain variability scoring. Postoperative pain scores, analgesic use, genetic variances and costs are measured.

Enrollment: 126 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing cardiac surgery via sternotomy (Coronary artery bypass graft (CABG) and/or valve replacement)
• Patients admitted to the ICU or PACU in the St. Antonius hospital
• Patients between 18 and 85 years old
• Patients weighing between 45 and 140 kg
• Written informed consent

Exclusion criteria

• Pregnancy/ breastfeeding
• Language barrier
• History of drug abuse
• Neurologic condition such as peripheral neuropathy
• Known remifentanil, fentanyl, morphine or paracetamol allergy
• Body Mass Index (BMI) > 35 kg/m2
• Prior cardiac surgery (re-operations);
• Patients with chronic pain conditions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Fentanyl

Active Comparator group

Description:

fentanyl bolus injections on an "as needed" base, next to the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Treatment:

Drug: Fentanyl

Drug: Fentanyl

Remifentanil

Active Comparator group

Description:

remifentanil, starting with 0.15 ug/Ideal Body Weight(IBW)(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Treatment:

Drug: Fentanyl

Drug: Remifentanil

Drug: Fentanyl