anaesthetic & critical care studies summaries

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Protocol v6.0 30/04/2025
​Rotherham Principal Investigator: Professor Anil Hormis
Research team member: Riya Rose Mathew

research topic:

Neuromuscular reversal and post-operative pulmonary complications in elective and emergency abdominal surgery

trial groups:

Intervention: Sugammadex 2-4mg/kg as a single IV bolus at the end of surgery—additional dose permitted
Control: Neostigmine 30-70mcg/kg as a single IV bolus at the end of surgery, with co-administration of Glycopyrrolate (eg 200mcg per 1 mg Neostigmine)—additional dose permitted

inclusion criteria:

• Patients having elective or emergency major abdominal surgery
• >50 years old
• Planned use of Rocuronium or Vecuronium for neuromuscular blockade
• Planned reversal of  neuromuscular blockade at end of surgery

exclusion criteria:

• Known allergy to Sugammadex, Neostigmine or Glycopyrrolate
• Planned invasive mechanical ventilation before or after surgery
• Clinician refusal (with clinical reason)

which surgeries:

​The trial is looking at major abdominal surgery. For Rotherham patients we will include elective total abdominal hysterectomy (open or laparoscopic, not vaginal) and complex abdominal wall repairs. As well as emergency exploratory laparotomy and other emergency colorectal surgery. 

consent:

Eligible patients will be approached by the research team before and on the day of surgery for trial consent and will be discussed with the elective/emergency list’s anaesthetist.

randomisation:

A member of the research team will check in with the anaesthetist towards the end of the case to randomise once you are sure the patient will definitely be reversed.
 
The anaesthetist will be given a declaration form to sign outlining they understand the study. They will be informed of the randomisation allocation and asked to ensure anaesthetic chart documentation includes:

• times of induction and extubation
  
• use of TIVA or inhaled agent
  
• doses of all muscle relaxants and reversal agents used
  
• FiO2, tidal volume and PEEP used for the majority of the case
  
• Use of neuromuscular monitoring (quantitative, qualitative or none)

 ***Please do not tell the research fellow which group the patient is in, so they can review the post-op pulmonary complications BLIND to the research groups.***