Aim:

To conduct a large clinical trial comparing two drugs used to improve recovery from general anaesthesia and prevent lung complications in patients undergoing major surgery.

Background:

General anaesthesia for major surgery requires specialised drugs which temporarily paralyse patients' muscles. This allows the anaesthetist to insert a breathing tube into the airway and artificially ventilate the patient, whilst also making it easier for surgeons to perform the operation. These drugs, called neuromuscular blocking agents (NMBAs), can only be given by trained anaesthetists using careful monitoring. At the end of surgery and anaesthesia, the NMBA-induced muscle paralysis is reversed with another drug. Despite precautions, incomplete reversal is common, leaving patients with short-term residual muscle weakness which affects breathing, coughing and swallowing and leading to lung complications such as pneumonia. These complications delay patient recovery, prolong hospital stays, and increase the chance of dying. More than 1.5 million patients receive a general anaesthetic requiring an NMBA each year, but the group most at risk of lung complications are those aged 50 years or over undergoing major chest or abdominal surgery. Anaesthetists choose between two drugs to reverse muscle paralysis, neostigmine or a newer drug, sugammadex, which reverses paralysis faster, and may help to prevent lung complications after surgery. However, this benefit has not yet been proven and must be weighed against two problems with the drug. Firstly, sugammadex can, very rarely, cause allergic reactions which will become more common with widespread use. Secondly, it is much more expensive than neostigmine, doubling the drug costs of a general anaesthetic. A survey of NHS anaesthetists has shown a 50:50 balance of opinion regarding which drug to use. We must provide robust evidence to guide anaesthetists in choosing which NMBA reversal drug to use in patients undergoing major chest and abdominal surgery at high risk for lung complications.

We aim to recruit 2500 patients aged ≥50 years old undergoing major elective or emergency abdominal or non-cardiac thoracic surgery, planned to receive neuromuscular blockade with rocuronium or vecuronium with reversal at the end of surgery.

Days alive and out of hospital at 30 days (DAH30)

Trial setup: 6 months (June 2022-November 2022)

Internal pilot: 12 months (December 2022-November 2023)

Main trial recruitment: 36 months (December 2022-November 2025)

Follow-up: 6 months (December 2025-May 2026)

Analysis and dissemination: 6 months (June 2026-November 2026)