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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