Comparison of the differences in the outcomes of patients receiving two different types of anaesthetics during heart surgery.

Phase 1

• Conditions: Cardiopulmonary bypass (CPB) and revascularisation-induced ischaemic reperfusion injury; MedDRA version: 20.0Level: LLTClassification code 10018061Term: General anesthesiaSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-000171-16-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-05
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified