Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery (COPIA)

King's College Hospital NHS Trust

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease; Cardiovascular Diseases

Treatments: Drug: Isoflurane, Sevoflurane or Desflurane; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04039854

2019-000171-16 (EudraCT Number)

KCH-PRO:19/001

216646 (Other Identifier)

Details and patient eligibility

About

The objective of this research proposal is to find out whether comparing the two different anaesthetic maintenance techniques (Propofol vs volatile anaesthetics) in adult patients undergoing heart surgery is practical for the anaesthetist treating the patients and whether it is feasible for the research team to recruit patients and follow them up after the operation.

Full description

All patients undergoing heart bypass surgery are given anaesthetics during the operation. There are two types of anaesthetic commonly given to patients undergoing heart bypass surgery.

Propofol is an anaesthetic that is delivered into the patient's vein. Other anaesthetics which are inhaled include Isoflurane, Sevoflurane and Desflurane and these are called volatile anaesthetics. Preliminary studies over the past ten years suggests that maintenance of general anaesthesia using only volatile anaesthetics has the potential to improve health outcomes after bypass surgery, when compared with propofol.

Volatile anaesthetics have been shown to protect the heart, the kidneys and the brain, however results of studies have been inconclusive. Currently both volatile anaesthetics and propofol are used equally in clinical practice in the UK.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (male and female) aged 18 years and above
• Written informed consent to participate
• Patients undergoing Coronary Artery Bypass Graft (CABG) surgery on Cardiopulmonary bypass (CPB) with or without valve surgery
• Additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 5 or higher

Exclusion criteria

• Pregnant or lactating women
• Allergy to propofol
• Previous diagnosis or suspected malignant hyperthermia
• Patients with a known sensitivity to any of the IMPs or other halogenated anaesthetics
• Concomitant therapy with glibenclamide or nicorandil (medications that may interfere with preconditioning)
• Inclusion in another clinical trial of an investigational medicinal product within the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Volatile anaesthetics arm

Active Comparator group

Description:

Patients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure.

Treatment:

Drug: Isoflurane, Sevoflurane or Desflurane

Propofol anaesthetics arm

Active Comparator group

Description:

Patients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure.

Treatment:

Drug: Propofol