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VITAL - Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery

Key information

Title:

VITAL - Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery

Chief Investigator: Dr Joyce Yeung and Dr Shaman Jhanji

Sponsor: University of Warwick

Funder: NIHR

Registration Number: ISRCTN62903453

Summary:

Aim

To perform a clinical trial to test whether total intravenous anaesthesia (TIVA) is better than inhalational anaesthesia for patients undergoing major non-cardiac surgery in the NHS.

Background

More than 1.5 million patients require general anaesthesia for major surgery each year in the NHS. General anaesthesia is most commonly maintained with inhalational anaesthesia where the patient breathes anaesthetic gas through a breathing tube whilst asleep. However, some patients receive an alternative called total intravenous anaesthesia, or ‘TIVA’. During a TIVA anaesthetic, the patient breathes oxygen through a breathing tube but is kept asleep by drugs given into a vein. Many anaesthetic doctors believe patients recover more quickly after TIVA, and small studies suggest patients prefer this technique.

Some anaesthetists are enthusiastic about TIVA because very early research suggests better survival for patients undergoing cancer surgery. However, this has not been proven and others are worried about possible risks including excess deaths and waking up during surgery. The evidence for TIVA has been positive so far but the clinical trials were very small and the results are not reliable. There has been one large trial for patients undergoing specialist cardiac surgery but this involves a very different kind of anaesthesia which we cannot easily compare. Despite the limited evidence, some doctors are starting to use TIVA as routine. We need to find out which technique is better in terms of getting patients home earlier, patient survival and avoiding any accidental awareness under anaesthesia. Our findings will help doctors select the best method to improve care and reduce harm for many patients.

Objectives

1. To test whether TIVA is superior to inhalational anaesthesia in terms of days alive and at home at 30 days (DAH30), survival and quality of recovery amongst patients undergoing major non-cardiac surgery.

2. To evaluate the safety of TIVA, in particular accidental awareness under anaesthesia.

3. To assess the cost-effectiveness of TIVA.

Sample size:

We aim to recruit 2500 patients undergoing major non-cardiac surgery in 40 NHS hospitals.

Duration:

The trial started on 04 January 2022 and will run for 54 months.

Information for Patients

Information for Site Staff

NIHR Associate PI Scheme

Study Protocol

Contact us:

Trial Manager: Claire Jacques

Trial Coordinator: Sneha Mehta

Data Entry Clerk: Elbe Or

Email: VITAL at warwick dot ac dot uk


Address:
VITAL Trial Team
Warwick Clinical Trials Unit,
Warwick Medical School,
University of Warwick,
Gibbet Hill Campus,
Coventry,
CV4 7AL