Every year, more than 1.5 million NHS patients undergoing major non-cardiac surgery are anaesthetised with either inhaled gas or an intravenous drip—and no one knows which is better for their long-term recovery. This matters because anaesthetists are increasingly switching to total intravenous anaesthesia (TIVA) based on weak evidence about cancer outcomes and environmental impact, not on solid data about patient survival or quality of life. The only large trial to date focused on cardiac surgery, which uses fundamentally different anaesthetic care. For the vast majority of non-cardiac operations, the benefits and harms of each technique remain unknown. The VITAL trial will randomise 2,500 patients across 40 NHS hospitals to receive either TIVA or inhalational anaesthesia. The primary measure is how many days patients spend alive and at home within 30 days of surgery—a patient-centred outcome that captures both survival and recovery. Secondary outcomes include mortality, complications, accidental awareness, and cost-effectiveness. If TIVA proves superior, it could shift anaesthetic practice across the NHS, improving recovery for hundreds of thousands of patients annually while also reducing greenhouse gas emissions from volatile agents. If inhalational anaesthesia is equivalent or better, it would justify retaining a familiar, cheaper technique. Either way, the trial will give clinicians and patients the robust evidence they currently lack.
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RESEARCH QUESTION: In adult patients (aged 50 and over) undergoing major non-cardiac surgery, does total intravenous anaesthesia (TIVA) lead to improved patient outcomes compared to inhalational anaesthesia? BACKGROUND: More than 1.5 million major non-cardiac surgeries are performed in the NHS each year. The two main anaesthetic techniques are inhalational anaesthesia (patient inhales volatile anaesthetic gases) and TIVA (patient receives intravenous infusion of anaesthetic drug). Inhalational anaesthesia is historically more popular, but many anaesthetists are changing to TIVA on the basis of low-quality data on cancer recurrence and greenhouse gas effects. There has been one large trial for patients undergoing cardiac surgery but this involves specialist anaesthesia and peri-operative care which differs completely to non-cardiac surgery. There is little clinical data to describe the benefit and harms of either technique for patients undergoing non-cardiac surgery. The VITAL trial will provide robust generalisable data comparing each technique in terms of patient recovery, survival and safety. AIM: To conduct a large data-efficient randomised trial comparing the clinical and cost effectiveness of TIVA and inhalational anaesthesia. 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. 3. To assess the cost-effectiveness of TIVA. METHODS:DESIGN: Multi-centre pragmatic randomised trial. We have partnered with the Perioperative Quality Improvement Programme (PQIP), a large national cohort study recruiting patients undergoing major non-cardiac surgery. VITAL will use the PQIP data collection procedures to maximise efficiency and reduce research burden. SETTING: 2500 patients undergoing major non-cardiac surgery in 40 NHS hospitals. INTERVENTION: Patients will be randomised to either TIVA or inhalational anaesthesia. OUTCOME MEASURES: The primary outcome is Days alive and at home at 30 days. Secondary outcomes: Days alive and at home at 90 days (DAH90); Mortality at 30 days, 90 days and six months; Quality of recovery after anaesthesia; Patient satisfaction with anaesthesia; postoperative complications; Accidental awareness under anaesthesia; Health resource use and health-related quality of life. SWAT: Rapid qualitative study of patient consent to examine ways of co-recruiting and consenting patients to complementary studies and explore patient, carer and staff views and experiences with different recruitment approaches. TIMELINE FOR DELIVERY: The trial will start on 1st November 2020 and run for 54 months. Month 0-6: Ethics, regulatory approvals and data linkage agreements. Month 6-12: internal pilot and SWAT. Month 13-42: Patient recruitment. Month 43-48: Complete patient follow-up, data cleaning. Months 49-54: Data analysis, scientific reports, plan dissemination. IMPACT AND DISSEMINATION: VITAL results will be a robust evaluation of clinical and cost effectiveness of intravenous and inhalational anaesthesia for patients undergoing major non-cardiac surgery. Dissemination will include an HTA monograph, publication in high-impact journal, and a patient-centered dissemination strategy to ensure our findings inform clinical guidelines and are accessible to patients and the public.
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