Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Pain Sternotomy Remifentanil Fentanyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Fentanyl

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.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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.

Fentanyl

Intervention Type DRUG

fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Remifentanil

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.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

starting with 0.15 ug/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.

Fentanyl

Intervention Type DRUG

fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Interventions

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Fentanyl

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.

Intervention Type DRUG

Remifentanil

starting with 0.15 ug/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.

Intervention Type DRUG

Fentanyl

fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Intervention Type DRUG

Other Intervention Names

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Sublimaze Ultiva Sublimaze

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No