Pain, Postoperative Clinical Trial
Official title:
Caffeine and Neurologic Recovery Following Surgery and General Anesthesia
Verified date | September 2021 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | January 17, 2020 |
Est. primary completion date | November 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Michigan Medicine | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Avidan MS, Maybrier HR, Abdallah AB, Jacobsohn E, Vlisides PE, Pryor KO, Veselis RA, Grocott HP, Emmert DA, Rogers EM, Downey RJ, Yulico H, Noh GJ, Lee YH, Waszynski CM, Arya VK, Pagel PS, Hudetz JA, Muench MR, Fritz BA, Waberski W, Inouye SK, Mashour GA; PODCAST Research Group. Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial. Lancet. 2017 Jul 15;390(10091):267-275. doi: 10.1016/S0140-6736(17)31467-8. Epub 2017 May 30. Erratum in: Lancet. 2017 Jul 15;390(10091):230. — View Citation
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Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15. Review. — View Citation
Gauthier EA, Guzick SE, Brummett CM, Baghdoyan HA, Lydic R. Buprenorphine disrupts sleep and decreases adenosine concentrations in sleep-regulating brain regions of Sprague Dawley rat. Anesthesiology. 2011 Oct;115(4):743-53. doi: 10.1097/ALN.0b013e31822e9f85. — View Citation
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Nelson AM, Battersby AS, Baghdoyan HA, Lydic R. Opioid-induced decreases in rat brain adenosine levels are reversed by inhibiting adenosine deaminase. Anesthesiology. 2009 Dec;111(6):1327-33. doi: 10.1097/ALN.0b013e3181bdf894. — View Citation
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Vlisides PE, Li D, McKinney A, Brooks J, Leis AM, Mentz G, Tsodikov A, Zierau M, Ragheb J, Clauw DJ, Avidan MS, Vanini G, Mashour GA. The Effects of Intraoperative Caffeine on Postoperative Opioid Consumption and Related Outcomes After Laparoscopic Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Jul 1;133(1):233-242. doi: 10.1213/ANE.0000000000005532. — View Citation
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Caffeine Intake: Number of Caffeinated Beverages (n) Consumed | Number of caffeinated beverages (n) consumed | postoperative day 0-7 | |
Other | Subacute Opioid Consumption: Postoperative Subacute Opioid Consumption, Oral Morphine Equivalents (mg) | Postoperative subacute opioid consumption, oral morphine equivalents (mg) | postoperative days 4-7 | |
Other | Sleep Disturbances: Incidence (%) of New, Self-reported Sleep Disturbances | Incidence (%) of new, self-reported sleep disturbances | postoperative days 0-3 | |
Other | EEG Spectral Power: Spectral Power (dB) Measured on EEG | Spectral power (dB) measured on EEG | time point 1: anesthetic emergence, approximate measurement 5-10 minutes after surgery end. Time point 2: postanesthesia care unit arrival, approximate measurement 20 minutes after end of surgery | |
Other | EEG Connectivity: Connectivity (Weighted Phase Lag Index, wPLI) Measured on EEG | Connectivity (weighted phase lag index, wPLI) measured on EEG | time point 1: anesthetic emergence, approximate measurement 5-10 minutes after surgery end. Time point 2: postanesthesia care unit arrival, approximate measurement 20 minutes after end of surgery | |
Other | Veterans Rand 12 Survey | Comprehensive survey that reports on general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy /fatigue levels, social functioning and mental health. Specifically, a physical and mental health score are reported, with both score scales ranging from 0 (worst possible outcome) to 100 (best possible outcome). | 30 days after surgery | |
Other | Persistent Opioid Use | Incidence of continued opioid use (%) on postoperative day (POD) 30 | Postoperative day (POD) 30 | |
Other | Quality of Recovery Survey | Self-report outcome measure evaluating recovery after surgery and anesthesia. Scoring ranges from 3-18, 3=poor 18=excellent | Postoperative day (POD) 1 | |
Other | Richards Campbell Sleep Questionnaire (RCSQ) | Self-report instrument for measuring sleep quality. Visual Analogue Scale (mm, 0-100, 0 =Deep sleep , 100 =Light sleep) | Preoperative (once before surgery on day of surgery) | |
Primary | Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | Postoperative opioid consumption, oral morphine equivalents (mg) | through postoperative day 3 | |
Secondary | Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale | Visual Analogue Scale (mm, 0-100, 0 = no pain, 100 = worst pain imaginable) | Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol. | |
Secondary | Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale | Behavioral Pain Scale, on a scale ranging from 3 to 12 when 3 is no pain and 12 is maximum pain | Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol. | |
Secondary | Time Until Anesthetic Emergence | Time from surgical dressing on to anesthetic emergence (min) | Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes | |
Secondary | Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) | Number (n) of participants with positive screens (score =8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms) | baseline through postoperative day 3 | |
Secondary | Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A) | Number (n) of participants with positive screens (score =8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms) | baseline through postoperative day 3 | |
Secondary | Cognitive Function as Assessed by Trail Making Test | Trail Making Test scores (seconds, 10-300,10 = fastest reported completion, 300 = maximum time allowed for completion). The change was calculated from the value at post anesthesia minus value at baseline. Higher values are considered to be worse outcomes. | morning of surgery baseline compared to postanesthesia care unit. Postanesthesia care unit measurement approximately 60 minutes after end of surgery | |
Secondary | Positive Affect as Assessed by PANAS (Positive and Negative Affect Schedule) | Positive Affect Score (n, 10-50, 10 = least positive affect, 50 = most positive affect) via PANAS (Positive and Negative Affect Schedule) | postoperative day 3 | |
Secondary | Negative Affect as Assessed by PANAS (Positive and Negative Affect Schedule) | Negative Affect Score (n, 10-50, 10 = least negative affect, 50 = most negative affect) via PANAS (Positive and Negative Affect Schedule) | postoperative day 3 | |
Secondary | Percentage of Delirious Patients Per Group | Number (n) of participants who has experienced at least one episode of delirium by the postoperative day 3 time point, as determined by daily Confusion Assessment Method (CAM). | By afternoon of postoperative day (POD) 3 |
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