Comparative Prospective Randomized Study in Postoperative Cardiac Surgery Patients on Analgesia with Morphine Continuous Infusion or Sublingual Sufentanil (Zalviso®).
- Conditions
- -Postoperative pain treatment after cardiac surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-004038-28-BE
- Lead Sponsor
- niversitair Ziekenhuis Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
All postoperative cardiac surgery patients aged between 18-75 y
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 20
-Patients with known allergy
-Patients with allergy to opioid drugs or a medical history of psychiatric disease --Patients with chronic inflammatory disease or chronic obstructive lung disease
-Pregnancy in female subjects in child-bearing age
-Body mass index greater than 35 kg/m2
-Participation in another clinical trial
-Drug abuse
-Psychological or emotional problems
-The use of nonsteroidal anti-inflammatory drugs or monoamine oxidase inhibitors
-Pain therapy with opioids 14 days before the start of the study
-Patients who are not cooperative or could not use PCA will be also excluded.
-All patients who cannot be weaned from the ventilator the day of surgery or the first postoperative day will be excluded
-Patients who are delirious or to whom no communication could be performed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The present study aims to assess postoperative pain after cardiac surgery by means of a standardized scoring system.;Secondary Objective: -Presence of nausea, vomiting, constipation <br>-Pruritus<br>-Consciousness;Primary end point(s): VAS score;Timepoint(s) of evaluation of this end point: twice daily
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Nausea, vomiting and constipation<br>-Pruritus<br>-Consciousness;Timepoint(s) of evaluation of this end point: twice daily