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Table 1 Eligibility criteria for participants

From: The NAPRESSIM trial: the use of low-dose, prophylactic naloxone infusion to prevent respiratory depression with intrathecally administered morphine in elective hepatobiliary surgery: a study protocol and statistical analysis plan for a randomised controlled trial

Inclusion criteria Exclusion criteria
> 18 years old at screening Allergy/sensitivity to naloxone
Presenting for elective major open hepatopancreaticobiliary resection under general anaesthetic Female subjects who are pregnant or breast feeding
Able/willing to give written informed consent and to comply with the requirements of the study Received any other investigational medicine within the prior 2 months
  Receiving anticonvulsant medications
  Cardiac arrhythmia with uncontrolled rate
  History of chronic opioid use/chronic pain
  Contraindication to intrathecal injection
  Documented history of obstructive sleep apnoea
  Treating clinician does not have equipoise to randomise this patient into the study