Early Phase 1
N=65
Caffeine and Neurologic Recovery Following Surgery and General Anesthesia
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03577730 ↗Enrolled (actual)
65
Serious AEs
9.4%
Results posted
Oct 2021
Primary outcome: Primary: Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) — 77; 51 oral morphine equivalents (mg) — p=0.092
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Caffeine Citrate (Drug); Dextrose Water (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) |
77; 51 | 0.092 |
| SECONDARY Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale |
40; 39 | 0.802 |
| SECONDARY Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale |
3; 3 | 0.320 |
| SECONDARY Time Until Anesthetic Emergence |
8; 10 | 0.670 |
| SECONDARY Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) |
2; 1 | 0.595 |
| SECONDARY Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A) |
2; 2 | 0.985 |
| SECONDARY Cognitive Function as Assessed by Trail Making Test |
10; 16 | 0.417 |
| SECONDARY Positive Affect as Assessed by PANAS (Positive and Negative Affect Schedule) |
35; 35 | 0.432 |
| SECONDARY Negative Affect as Assessed by PANAS (Positive and Negative Affect Schedule) |
12; 12 | 0.673 |
| SECONDARY Percentage of Delirious Patients Per Group |
7; 14 | 0.058 |
Summary
The ongoing opioid epidemic is a public health crisis, and surgical patients are particularly vulnerable to opioid-dependency and related risks. Emerging data suggest that caffeine may reduce pain after surgery. Thus, the purpose of this study is to test whether caffeine reduces pain and opioid requirements after surgery. The investigators will also test whether caffeine improves mood and brain function (e.g., learning, memory) after surgery.
Eligibility Criteria
Inclusion Criteria
- Adult (>/= 18 years old) undergoing non-cardiac, non-neurologic, non-major vascular surgery requiring general anesthesia
Exclusion Criteria
- Emergency surgery
- Cognitive impairment precluding capacity for informed consent
- Uncontrolled cardiac arrhythmias
- Seizure disorders
- Preoperative opioid use
- Diabetes
- Liver failure
- Pregnancy
- Breastfeeding
- Severe visual or auditory impairment (may hinder cognitive function testing)
- Patients unable to speak English.
Data sourced from ClinicalTrials.gov (NCT03577730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.