Respiratory Depression
Conditions
Brief summary
This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.
Detailed description
Delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. This respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. Other associated side effects include pruritus, nausea and vomiting and sedation. Naloxone is the most effective treatment for these side effects. However, it is usually given as a reactive treatment when the side effect presents. The hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. The primary endpoint is a reduction in respiratory depression.
Interventions
DRUGNaloxone
used to block the effects of opioids, especially in overdose
DRUGPlacebo
Placebo, ineffective control arm
Sponsors
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory depression | within 16 - 24 hours of participation |
Secondary
| Measure | Time frame |
|---|---|
| Measure of occurrence of pain | within 16 - 24 hours of participation |
| Requirement for rescue analgesia | within 16 - 24 hours of participation |
| Nausea/Vomiting | within 16 - 24 hours of participation |
| Pruritus | within 16 - 24 hours of participation |
Countries
Ireland
Outcome results
None listed