The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
Sponsor: National Institute on Aging (NIA)
A observational or N/A phase clinical study on Mild Cognitive Impairment and Postoperative Cognitive Dysfunction, this trial is ongoing. The trial is conducted by National Institute on Aging (NIA) and has accumulated 9 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Delirium is a syndrome characterized by failure of basic cognitive functions that affects approximately 20-50% of older surgical patients. Delirium during surgical recovery is associated with increased mortality, cognitive and functional decline, and prolonged hospitalization. In fact, 3-year survival rates for acutely hospitalized patients with delirium, and subsyndromal delirium, are both less than 50%. Older age is predictive of delirium after surgery, and with aging surgical populations, the incidence of postoperative delirium and related complications are likely to increase in the coming years. Caffeine represents a novel, neurobiologically informed candidate intervention for reducing risk of early postoperative delirium. Caffeine promotes arousal via adenosine receptor antagonism and improves cognitive function concurrent with increased cortical cholinergic tone. Our preliminary data suggest that caffeine reduces risk of postanesthesia care unit (PACU) delirium in adult non-cardiac surgery patients by optimizing cortical dynamics for cognition. Caffeine also optimizes key neurocognitive processes that support information processing and may improve other, related aspects of clinical recovery, such as rebound headache in habitual caffeine users. The objective of this trial is to thus test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, the primary hypothesis is that caffeine will reduce the incidence of...
Delirium is a syndrome characterized by failure of basic cognitive functions that affects approximately 20-50% of older surgical patients. Delirium during surgical recovery is associated with increased mortality, cognitive and functional decline, and prolonged hospitalization. In fact, 3-year survival rates for acutely hospitalized patients with delirium, and subsyndromal delirium, are both less than 50%. Older age is predictive of delirium after surgery, and with aging surgical populations, the incidence of postoperative delirium and related complications are likely to increase in the coming years.
Caffeine represents a novel, neurobiologically informed candidate intervention for reducing risk of early postoperative delirium. Caffeine promotes arousal via adenosine receptor antagonism and improves cognitive function concurrent with increased cortical cholinergic tone. Our preliminary data suggest that caffeine reduces risk of postanesthesia care unit (PACU) delirium in adult non-cardiac surgery patients by optimizing cortical dynamics for cognition. Caffeine also optimizes key neurocognitive processes that support information processing and may improve other, related aspects of clinical recovery, such as rebound headache in habitual caffeine users. The objective of this trial is to thus test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, the primary hypothesis is that caffeine will reduce the incidence of postoperative delirium. The secondary objectives are to (1) test whether caffeine positively impacts the quality of postoperative recovery via validated patient-reported measures and (2) identify neural correlates of delirium and Mild Cognitive Impairment via advanced electroencephalographic (EEG) analysis.
Status Flow
Change History
9 versions recorded-
Apr 21, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting · Phase: PHASE2 → None
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Aug 2025 — Apr 2026 [monthly]
Recruiting PHASE2
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Sep 2024 — Aug 2025 [monthly]
Recruiting PHASE2
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE2
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Apr 2024 — Jul 2024 [monthly]
Recruiting PHASE2
▶ Show 4 earlier versions
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May 2023 — Apr 2024 [monthly]
Recruiting PHASE2
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Mar 2023 — May 2023 [monthly]
Recruiting PHASE2
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Feb 2023 — Mar 2023 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Nov 2022 — Feb 2023 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.
Contact Information
- National Institute on Aging (NIA)
- University of Michigan
For direct contact, visit the study record on ClinicalTrials.gov .