SINFONIA

• Research type

  Research Study

• Full title

  Sugammadex for prevention of post-operative pulmonary complications

• IRAS ID

  1006043

• Contact name

  Jon Silversides

• Contact email

  j.silversides@qub.ac.uk

• Sponsor organisation

  Belfast Health and Social Care Trust

• ISRCTN Number

  ISRCTN15109717

• Research summary

  AIM: To conduct a large clinical trial comparing two drugs used to prevent lung complications and improve recovery from general anaesthesia in patients undergoing major surgery.
  BACKGROUND: General anaesthesia for major surgery requires specialised drugs which temporarily paralyse patients' muscles, called neuromuscular blocking agents (NMBAs). At the end of surgery, the NMBA-induced muscle paralysis is reversed with another drug. Despite careful monitoring, incomplete reversal is common, impacting on breathing patterns and predisposing to lung complications such as pneumonia. These complications are common, delay patient recovery and increase the risk of death and long-term health problems.
  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 sugammadex. Firstly, it is more expensive than neostigmine, doubling the drug costs of a general anaesthetic. Secondly, there is concern that allergic reactions may become more common over time with widespread use, although these are extremely rare at present.
  METHODS: We plan a clinical trial of patients aged 50 years and over undergoing major chest or abdominal surgery. The trial will involve 2500 patients from 40 UK sites over 3 years. Each patient who agrees to participate will be randomly allocated to receive either sugammadex or neostigmine for NMBA reversal after surgery. We will follow patients up to find out if using one drug results in faster recovery or lower risk of death than the other. In a subgroup of 250 patients, we will test to find out whether there are any signs that allergy to sugammadex has developed and could be a problem in a second operation. This will help us understand the risks and benefits for each drug.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  22/EM/0231

• Date of REC Opinion

  20 Dec 2022

• REC opinion

  Further Information Favourable Opinion