The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Dublin
• Treatments: Morphine; Naloxone

Criteria

Inclusion Criteria:

• Subjects must be aged 18 years or above at baseline

• Diagnosed with any hepatobiliary condition requiring an elective major surgical resection under general anaesthetic.

• Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol

Exclusion Criteria:

• Allergy/sensitivity to naloxone

• Female subjects who are pregnant or breast-feeding.

• Subjects who have received any other investigational agent within 2 months

• Subjects taking anticonvulsant medications for epilepsy

• Subjects who have a cardiac arrhythmia with an uncontrolled rate

• Subjects who have a history of chronic opioid use / chronic pain

• Any contraindication to intrathecal injection eg coagulopathy

• Documented history of obstructive sleep apnoea

• Treating clinician feels not in the patients best interests to be randomised