None listed
Conditions
Brief summary
DeCaf-Me: Prevent Delirium with Caffeine or Melatonin is a open label cross over factorial randomised controlled trial that is aiming to recruit 57 spinal or vascular participants over the age of 65 at Royal Prince Alfred Hospital. Participants will be recruited via the Department of Anaesthetics in the pre-admission clinic. They will be assessed for eligibility and risk at this time, informed consent will be done pre-operatively. Participants will be randomised to one of four arms - 1)100 mg caffeine at 7am and 2pm, 4 mg melatonin at 8pm, 2)100mg caffeine at 7am and 2pm, 3)4mg melatonin at 8pm or 4)no intervention. Primary outcomes are incidence of post-operative delirium on day 1 and secondary outcomes are Richmond Agitation and Sedation Score, differences in EEG power from 0.5-0.6Hz, changes in incidence of delirium, post-operative pain and opioid use. Patients will be monitored intraoperatively via BIS monitoring/EEG and on post operative days 1-3 receive delirium assessments on the ward/ICU. Additionally an EEG will be preformed on post-operative day 1 and a 10mL blood sample will be collected for biomarker analysis during standard blood collection intra-operatively and on post-operative day 1. Participants will be finished on post-operative day 7 after completing a cognitive assessment in person or over the phone. The rationale of this study is that the use of post-operative caffeine could have an effect on inflammation that could effect post-operative delirium severity and the consequential slowing of electroencephalogram readings. Additionally the use of caffeine and melatonin to help maintain circadian rhythms could help promote more restful sleep and reinforce normal sleep patterns which can reduce instances of post-operative delirium.
Interventions
The study will have the following three intervention arms:
1) Oral 100 mg Caffeine (NoDoz) twice daily at 0700 and 1400 and oral Melatonin (circadian) 4mg once per day at 2000 on post operative days 1 and 2
2) Oral 100 mg Caffeine twice daily at 0700 and 1400 on post-operative days 1 and 2
3) Oral 4mg Melatonin once daily at 2000 on post-operative days 1 and 2
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing vascular or spinal surgery
Exclusion criteria
Non-english speaking Participants who may have received an investigational new drug within the last 7 days/weeks. Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements such as preexisting dementia. Participants with prior known intolerance/allergy to caffeine Undergoing cardiac or intracranial neurosurgery Known history of intolerance of caffeine or melatonin
Outcome results
None listed