NCT04039854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2019

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

June 7, 2019

Last Update Submit

February 23, 2021

Conditions

Coronary Heart DiseaseCardiovascular Diseases

Keywords

AnaesthesiaCoronary Artery Bypass SurgeryCardioprotection

Outcome Measures

Primary Outcomes (2)

  • Recruitment rate

    To identify whether it is feasible to recruit up to 50 patients across 2 tertiary cardiac surgery centres within approximately 10 months.

    Collected over the recruitment period of 10 months

  • To identify barriers to recruitment.

    This data will be completed on a screening log.

    Collected over the recruitment period of 10 months

Secondary Outcomes (17)

  • Feasibility of maintaining follow-up rates of over 95%

    Collected over the recruitment period of 10 months

  • Assessment of effectiveness of patient identification and screening processes

    Collected over the recruitment period of 10 months

  • 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.

    Collected over the recruitment period of 10 months

  • To investigate whether it is feasible to maintain routine data collection and follow up rates greater than 90% over the trial period.

    Collected over the full trial period of 24 months

  • To investigate whether it is feasible to achieve 95% data collection of Low Cardiac Output Syndrome for the full trial over the trial period.

    Collected over the full trial period of 24 months

  • +12 more secondary outcomes

Study Arms (2)

Volatile anaesthetics arm

ACTIVE COMPARATOR

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

Drug: Isoflurane, Sevoflurane or Desflurane

Propofol anaesthetics arm

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Isoflurane, Sevoflurane or DesfluraneDRUG

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.

Volatile anaesthetics arm
PropofolDRUG

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.

Propofol anaesthetics arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

NOT YET RECRUITING

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38724266DERIVED

MeSH Terms

Conditions

Coronary DiseaseCardiovascular Diseases

Interventions

IsofluraneSevofluraneDesfluranePropofol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl EthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Dr Gudrun Kunst

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberley Potter

CONTACT

02079272505kimberley.potter@LSHTM.ac.uk

Richard Evans

CONTACT

02072972665richard.evans@LSHTM.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

July 31, 2019

Study Start

November 20, 2019

Primary Completion

November 30, 2021

Study Completion

January 31, 2022

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Anonymous participant data may be shared with other researchers

Locations

GB(2)