A randomised trial to identify the association between glucose levels and the type of anaesthesia in patients undergoing major non-cardiac surgery

GlucoVITAL – randomised trial of Volatile vs Total intravenous Anaesthetic for major non-cardiac surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46862025

Enrollment

450

Registered

2023-09-13

Start date

2023-09-15

Completion date

Unknown

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major elective noncardiac surgery under general anaesthesia Surgery

Interventions

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 the

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026