A randomised trial to identify the association between glucose levels and the type of anaesthesia in patients undergoing major non-cardiac surgery
| ISRCTN | ISRCTN46862025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46862025 |
| IRAS number | 324653 |
| Secondary identifying numbers | 157967, IRAS 324653, CPMS 56485 |
- Submission date
- 01/09/2023
- Registration date
- 13/09/2023
- Last edited
- 28/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
More than 1.5 million major operations not involving the heart are performed in the NHS each year. General anaesthesia is most often given with an inhaled anaesthetic gas. A commonly used alternative is to give anaesthesia using anaesthetic drugs given into the veins, a technique called total intravenous anaesthesia (TIVA). These two types of anaesthetic may have important differences in affecting how the body uses blood sugar for several days after surgery.
Higher blood sugar often occurs after surgery, making cells work less well. High blood sugar levels make inflammation and injury to important organs like the heart and brain worse and increase the risk of infections. Recovery after surgery is far slower if glucose levels are higher during and after the operation. Remarkably, for the vast majority of individuals who are not diabetic, blood sugar is not checked at all after surgery. This is because of the previous lack of available technology that can monitor blood sugar without the need for lots of unpleasant blood tests that require much more nursing care. The VITAL trial measures the effect of each anaesthetic technique by assessing recovery, complications and safety. This study is designed to add no extra steps/inconvenience for VITAL participants. It asks whether intravenous anaesthesia achieves more normal control of blood sugar than inhalational anaesthesia. If intravenous anaesthesia improves blood sugar control, we would expect to see fewer complications in individuals most at risk of developing higher blood sugar after major surgery.
Who can participate?
Patients more than 50 years old who are undergoing planned surgery and are already taking part in the VITAL trial, which is testing whether intravenous anaesthesia is superior to inhalational anaesthesia
What does the study involve?
Participants are randomly allocated to receive either intravenous or inhalational anaesthesia. The researchers will monitor blood sugar non-invasively using a painless device placed in the upper arm during the operation under anaesthesia to see how blood sugar changes after each type of anaesthetic. They will measure whether there is damage to the heart using blood tests, from samples taken routinely before and the morning after surgery. Blood tests from a teaspoon of blood taken before and 24 hours after surgery will assess why blood sugar changes from levels before surgery. These tests will help identify individuals who may benefit from blood sugar monitoring after surgery in the future. This study will help us understand whether intravenous anaesthesia minimises high blood sugar levels that promote complications after noncardiac surgery, compared to inhalational anaesthesia- particularly in individuals most at risk of developing higher blood sugar levels.
What are the possible benefits and risks of participating?
Individuals with, or susceptible to, insulin resistance before non-cardiac surgery may benefit from an anaesthesia approach that is more personalised. This study will help improve recovery from surgery for elderly patients, find out about the long-term harm than can result from anaesthesia, and study if the correct approach could help reduce the risk of complications after surgery. There are minimal risks for research participants.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
September 2023 to December 2025
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Prof. Gareth Ackland, g.ackland@qmul.ac.uk
Contact information
Principal Investigator
William Harvey Research Institute
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
John Vane Science Centre
Charterhouse Square
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0003-0565-5164 |
|---|---|
| Phone | +44 (0)20 3594 0351 |
| g.ackland@qmul.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Prevention |
| Participant information sheet | 44231_PIS_V3.0_13Aug23.pdf |
| Scientific title | GlucoVITAL – randomised trial of Volatile vs Total intravenous Anaesthetic for major non-cardiac surgery |
| Study acronym | GlucoVITAL |
| Study objectives | To identify the association between intraoperative glucose levels and the mode of anaesthesia (total intravenous anaesthesia vs inhalational) in patients undergoing major noncardiac surgery. |
| Ethics approval(s) |
Approved 17/08/2023, London - Fulham Research Ethics Committee (2 Redman Place, Stratford Health Research Authority, London, E20 1JQ, United Kingdom; +44 (0)207 104 8084; fulham.rec@hra.nhs.uk), ref: 23/PR/0677 |
| Health condition(s) or problem(s) studied | Major elective noncardiac surgery under general anaesthesia |
| Intervention | Following the provision of informed consent, participants will be enrolled into the study. Real-time continuous glucose monitoring will be measured using a Dexcom G7 sensor. The patient will wear these monitors continuously from induction of anaesthesia to up to 10 days postoperatively (maximum usage duration for each sensor) or hospital discharge whichever occurs sooner. Blood samples (approximately 15 ml) will be collected to measure: 1. Blood-gas measurements for glucose 2. Myocardial injury 3. Presence and/or development of insulin resistance 4. Leukocyte and metabolic profiles Participants will be contacted by telephone on Day 30 (+ 2 days) to collect data on hospital readmission and any postoperative complications that are classed as Clavien-Dindo Severity Grade II or above. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dexcom G7 sensor |
| Primary outcome measure | Current primary outcome measure as of 23/06/2025: Blood glucose measured using Blood-Gas measurements for glucose before surgery, at the end of surgery and on day one after surgery Previous primary outcome measure: 1. Blood-gas measurements for glucose before surgery, at the end of surgery and on day one after surgery 2. Continuous glucose measurements using continuous glucose monitoring up to 10 days after surgery or hospital discharge, whichever is sooner |
| Secondary outcome measures | 1. DAH30 is a continuous number between 0 and 30, reflecting the total number of days that a patient spends alive and at home within 30 days after surgery. In this definition, home reflects any place other than hospital. If a patient dies within those 30 days, their value is set to 0. DAH30 captures the development of all-cause complications which prevents patients leaving hospital after surgery. 2. Increase in serum high sensitivity troponin-T (Elecsys, Roche Diagnostics) concentration of: 2.1. An absolute value of 15 ng L-1 on day one after surgery OR 2.2. An increase of 5 ng L-1 from the preoperative value on day one after surgery when the preoperative value of 15 ng L-1 3. Incidence of postoperative infection within 30 days after surgery. This is defined as one or more of the following infections of Clavien-Dindo grade II or greater: 3.1. Superficial surgical site infection 3.2. Deep surgical site infection 3.3. Organ space surgical site infection 3.4. Pneumonia 3.5. Urinary tract infection 3.6. Laboratory-confirmed bloodstream infection 3.7. Infection, source uncertain; this is defined as an infection which could be more than one of the above but it is unclear which |
| Overall study start date | 15/12/2022 |
| Completion date | 30/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 50 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 450 |
| Key inclusion criteria | Current inclusion criteria as of 13/11/2024: 1. Patients aged 50 years and over 2. Elective major noncardiac surgery under general anaesthesia (as per PQIP inclusion criteria) 3. Written informed consent for study participation _____ Previous inclusion criteria: 1. Patients aged 50 years and over undergoing elective major noncardiac surgery under general anaesthesia and consented to the VITAL trial 2. Written informed consent for study participation |
| Key exclusion criteria | Current exclusion criteria as of 13/11/2024: 1. Known contraindication to either total intravenous anaesthesia or inhalational anaesthesia 2. Clinical refusal 3. Procedures where the participant is not expected to survive for 30 days 4. Previous participation and completion in the GlucoVITAL trial 5. Patients unable to give informed consent or complete questionnaires _____ Previous exclusion criteria: 1. Known contraindication to either total intravenous anaesthesia or inhalational anaesthesia 2. Clinical refusal 3. Procedures where the participant is not expected to survive for 30 days 4. Previous participation and completion in the VITAL trial 5. Patients unable to give informed consent or complete questionnaires |
| Date of first enrolment | 15/09/2023 |
| Date of final enrolment | 30/09/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
London
SW3 6JJ
United Kingdom
Clydebank
G81 4DY
United Kingdom
Croydon University Hospital
530 London Road
Thornton Heath
CR7 7YE
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
London
SW10 9NH
United Kingdom
London
E13 8SL
United Kingdom
Bordesley Green
Birmingham
B9 5ST
United Kingdom
Croydon
CR7 7YE
United Kingdom
Watford
WD18 0HB
United Kingdom
Barking
IG11 9LX
United Kingdom
Stanmore
HA7 4LP
United Kingdom
London
N19 5NF
United Kingdom
Sponsor information
University/education
Research Services, Dept. W
c/o Mile End Post Room
327 Mile End Road
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)20 7882 5555 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 10/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal, conference presentations and webcasts. Intent to publish the main paper as soon as possible after completion of the trial. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request. Enquiries can be sent to the email address p.dias@qmul.ac.uk. Ideally, the Chief Investigator (CI), Prof. Gareth Ackland, should be contacted first with the enquiry for CI approval. Data would typically only be available to share at the end of the study. All data shared will be anonymised. Consent from participants was required and obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 13/08/2023 | 12/09/2023 | No | Yes |
| Protocol file | version 3.0 | 13/08/2023 | 12/09/2023 | No | No |
| Participant information sheet | version 6.0 | 30/05/2024 | 13/11/2024 | No | Yes |
| Protocol file | version 5.0 | 24/04/2024 | 13/11/2024 | No | No |
| Protocol article | 24/05/2025 | 16/06/2025 | Yes | No | |
| Protocol file | version 6.0 | 13/03/2025 | 23/06/2025 | No | No |
| Results article | 24/07/2025 | 28/07/2025 | Yes | No |
Additional files
Editorial Notes
28/07/2025: Publication reference added.
15/07/2025: The study participating centres, Barts Health NHS Trust, and University Hospitals Birmingham NHS Foundation Trust, were removed.
26/06/2025: Newham General Hospital, Heartlands Hospital, Croydon University Hospital, Watford General Hospital, Barking Hospitals, Royal National Orthopaedic Hospital and The Whittington Hospital were added as study participating centres.
23/06/2025: The following changes were made:
1. Protocol version 6.0 uploaded.
2. The recruitment end date was changed from 15/06/2025 to 30/09/2025.
3. The overall study end date was changed from 15/12/2025 to 30/12/2025.
4. The primary outcome measure was changed.
16/06/2025: Publication reference added.
13/11/2024: The following changes were made to the trial record following a substantial amendment converting the study from observational to interventional:
1. Uploaded protocol v5.0 (not peer-reviewed) as an additional file.
2. The participant information sheet v5.0 was uploaded as an additional file.
3. The public title was changed from "An observational study to identify the association between glucose levels and the type of anaesthesia in patients undergoing major non-cardiac surgery" to "A randomised trial to identify the association between glucose levels and the type of anaesthesia in patients undergoing major non-cardiac surgery".
4. The scientific title was changed from "Observational mechanistic sub-study of the volatile vs total intravenous anaesthetic for major non-cardiac surgery (VITAL) trial" to "GlucoVITAL – randomised trial of Volatile vs Total intravenous Anaesthetic for major non-cardiac surgery".
5. The study design was changed from "National multi-centre prospective observational cohort study" to "Interventional randomized controlled trial".
6. The inclusion criteria were changed.
7. The exclusion criteria were changed.
8. The study participating centre The Newcastle upon Tyne Hospitals NHS Foundation Trust was removed and Liverpool University Hospitals NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, and Chelsea & Westminster Hospital
were added.
04/10/2023: Internal review.
12/09/2023: Study's existence confirmed by the HRA.
