Clinical trial NCT04039854: Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery
Official title: Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery - a Randomised Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Cardiovascular Diseases
Keywords: Anaesthesia
Coronary Artery Bypass Surgery
Cardioprotection
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2019-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Collected over the recruitment period of 10 months
measure: To identify barriers to recruitment.
timeFrame: Collected over the recruitment period of 10 months
Secondary outcomes:
measure: Feasibility of maintaining follow-up rates of over 95%
timeFrame: Collected over the recruitment period of 10 months
measure: Assessment of effectiveness of patient identification and screening processes
timeFrame: Collected over the recruitment period of 10 months
measure: To investigate whether it is feasible to recruit at least 10% of all potentially eligible patients at the two tertiary cardiac surgery centres within a period of 10 months.
timeFrame: Collected over the recruitment period of 10 months
measure: To investigate whether it is feasible to maintain routine data collection and follow up rates greater than 90% over the trial period.
timeFrame: Collected over the full trial period of 24 months
measure: To investigate whether it is feasible to achieve 95% data collection of Low Cardiac Output Syndrome for the full trial over the trial period.
timeFrame: Collected over the full trial period of 24 months
measure: To investigate whether it is feasible to achieve 95% data collection of Myocardial injury, assessed by ischaemic serum markers: hsTnT, MyC, for the full trial over the trial period.
timeFrame: Preop, 6 hrs after arrival in CCU, and postop day 1 and 2. Collected over the full trial period of 24 months
measure: To investigate whether it is feasible to achieve 90% data collection of MACCE (stroke, non-fatal myocardial infarction, death from any cause) for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Cardiac related mortality at 30 days for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Postoperative in hospital atrial fibrillation requiring treatment for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Acute Kidney Injury (according to Kidney Disease: Improving Global Outcomes guidelines) for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of In-hospital postoperative delirium (assessed by the confusion assessment method) for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Respiratory complications needing prolonged ventilation (>24 hours) for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Length of stay in the critical care unit (CCU) for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Length of hospital stay for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of WHO Disability Assessment Schedule (WHODAS) for the full trial over the trial period.
timeFrame: Data collected at 30 days post op.
measure: To investigate whether it is feasible to achieve 90% data collection of Quality of Life Questionnaire (Euroqol, EQ-5D-5L) for the full trial over the trial period.
timeFrame: Data collected at Baseline and 30 days postoperative
measure: To investigate whether it is feasible to achieve 90% data collection of Days alive and at home for the full trial over the trial period.
timeFrame: Data collected at 30 days postoperative
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College Hospital NHS Trust
name: Dr Gudrun Kunst
role: PRINCIPAL_INVESTIGATOR
References: