EUCTR2019-000171-16-GB
Active, not recruiting
Phase 1
Comparison between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes following Cardiac Surgery - a Randomised Controlled Feasibility Trial - COPIA
ConditionsCardiopulmonary bypass (CPB) and revascularisation-induced ischaemic reperfusion injuryMedDRA version: 20.0Level: LLTClassification code 10018061Term: General anesthesiaSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cardiopulmonary bypass (CPB) and revascularisation-induced ischaemic reperfusion injury
- Sponsor
- King's College Hospital NHS Foundation Trust
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients (male and female) aged 18 years and above
- •2\.Written informed consent to participate
- •3\.Patients undergoing Coronary Artery Bypass Graft (CABG) surgery on Cardiopulmonary bypass (CPB) with or without valve surgery
- •4\. Additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 5 or higher (higher scores indicating a greater risk of death; 0 indicates minimum risk and \=6 indicates high risk)
- •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 50
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1\.Pregnant or lactating women
- •2\.Allergy to propofol
- •3\.Previous diagnosis or suspected malignant hyperthermia
- •4\. Patients with a known sensitivity to any of the IMPs or other halogenated anaesthetics
- •5\. Concomitant therapy with Glibenclamide, Allopurinol, Theophylline or Nicorandil (medications that may interfere with remote ischemic preconditioning)
- •6\. Inclusion in another clinical trial of an investigational medicinal product within the last 3 months.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
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