Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery
NCT ID: NCT04039854
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2019-11-20
2022-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Volatile anaesthetics arm
Patients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure.
Isoflurane, Sevoflurane or Desflurane
The volatile anaesthetic agent will be administered via inhalation, i.e. ventilation through alveolar membrane in lungs) during the maintenance of anaesthesia. During CPB the volatile anaesthetic agent will be administered through the oxygenator oxygen inflow of the CPB machine.
The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure.
The administration of the volatile anaesthetic agent will be started after induction of anaesthesia and it will be ended at the end of surgery, before the patient is transferred to the CCU.
Propofol anaesthetics arm
Patients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure.
Propofol
Patients will receive propofol only during the surgical procedure. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with BIS 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist.
Interventions
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Isoflurane, Sevoflurane or Desflurane
The volatile anaesthetic agent will be administered via inhalation, i.e. ventilation through alveolar membrane in lungs) during the maintenance of anaesthesia. During CPB the volatile anaesthetic agent will be administered through the oxygenator oxygen inflow of the CPB machine.
The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure.
The administration of the volatile anaesthetic agent will be started after induction of anaesthesia and it will be ended at the end of surgery, before the patient is transferred to the CCU.
Propofol
Patients will receive propofol only during the surgical procedure. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with BIS 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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London School of Hygiene and Tropical Medicine
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
King's College Hospital NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Dr Gudrun Kunst
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Locations
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St Thomas' Hospital
London, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Martin John
Role: primary
Gudrun Kunst
Role: primary
References
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Milne B, John M, Evans R, Robertson S, O Scanaill P, Murphy GJ, Landoni G, Marber M, Clayton T, Kunst G. Comparison between propofol and total inhalational anaesthesia on cardiovascular outcomes following on-pump cardiac surgery in higher-risk patients: a randomised controlled pilot and feasibility study. Open Heart. 2024 May 9;11(1):e002630. doi: 10.1136/openhrt-2024-002630.
Other Identifiers
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2019-000171-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
216646
Identifier Type: OTHER
Identifier Source: secondary_id
KCH-PRO:19/001
Identifier Type: -
Identifier Source: org_study_id
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