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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.
Opioid-related deaths have quadrupled in the last 20 years, and nearly half of these deaths currently involve prescription opioids. Surgical patients often experience moderate-to-severe pain is common after major surgery, and surgery is associated with a 14-fold increased risk of opioid dependency compared to non-surgical controls, even after minor surgery. Furthermore, mood disorders (e.g., depression) are independently associated with persistent opioid use postoperatively, and signs of postoperative depression are common after major surgery. Thus, given these risk factors, surgical patients are at particularly high risk for opioid dependency postoperatively. Interventions that (1) reduce opioid burden, and (2) improve mood and neuropsychological function may mitigate the risk of postoperative opioid dependency. Preliminary laboratory and clinical findings demonstrate that caffeine may reduce pain after surgery, which may translate to lower opioid requirements. The study tests the hypothesis that intraoperative caffeine administration will improve opioid consumption, pain, and neuropsychological recovery in patients undergoing surgery. Through validated assessment measures, the research team will study the effects of caffeine in relation to postoperative opioid requirements, pain, and neuropsychological (e.g., cognition, depression, anxiety) trajectory after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. |
|
| Control | Placebo Comparator | Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine Citrate | Drug | Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | Postoperative opioid consumption, oral morphine equivalents (mg) | through postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Caffeine Intake: Number of Caffeinated Beverages (n) Consumed | Number of caffeinated beverages (n) consumed | postoperative day 0-7 |
| Subacute Opioid Consumption: Postoperative Subacute Opioid Consumption, Oral Morphine Equivalents (mg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Vlisides, MD | Assistant Professor of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26313057 | Background | Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26. | |
| 15007400 | Background |
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A total of 71 subjects were consented. Data is reported for a total of 60 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants. |
| FG001 | Control | Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | Postoperative opioid consumption, oral morphine equivalents (mg) | Posted | Median | Inter-Quartile Range | oral morphine equivalents (mg) | through postoperative day 3 |
|
Data were collected at 30 days.
AEs are presented for all 64 participants who received the study drug (caffeine or placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Prepared intravenous piggyback solution of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. Caffeine Citrate: Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Vlisides | University of Michigan | 734-936-4280 | pvliside@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2020 | Aug 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009293 | Opioid-Related Disorders |
| D010146 | Pain |
| D060825 | Cognitive Dysfunction |
| D003693 | Delirium |
| D000071257 | Emergence Delirium |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C026189 | caffeine citrate |
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This will be a single-center, quadruple-blinded, pilot randomized controlled trial at the University of Michigan Health System.
| Dextrose Water | Drug | Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants. |
|
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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Postoperative subacute opioid consumption, oral morphine equivalents (mg)
| postoperative days 4-7 |
| Sleep Disturbances: Incidence (%) of New, Self-reported Sleep Disturbances | Incidence (%) of new, self-reported sleep disturbances | postoperative days 0-3 |
| 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 |
| 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 |
| 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 |
| Persistent Opioid Use | Incidence of continued opioid use (%) on postoperative day (POD) 30 | Postoperative day (POD) 30 |
| 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 |
| 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) |
| Kundermann B, Krieg JC, Schreiber W, Lautenbacher S. The effect of sleep deprivation on pain. Pain Res Manag. 2004 Spring;9(1):25-32. doi: 10.1155/2004/949187. |
| 16551935 | Background | Vaurio LE, Sands LP, Wang Y, Mullen EA, Leung JM. Postoperative delirium: the importance of pain and pain management. Anesth Analg. 2006 Apr;102(4):1267-73. doi: 10.1213/01.ane.0000199156.59226.af. |
| 9539601 | Background | Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019. |
| 17014605 | Background | Karp JF, Reynolds CF 3rd, Butters MA, Dew MA, Mazumdar S, Begley AE, Lenze E, Weiner DK. The relationship between pain and mental flexibility in older adult pain clinic patients. Pain Med. 2006 Sep-Oct;7(5):444-52. doi: 10.1111/j.1526-4637.2006.00212.x. |
| 26909151 | Background | Dolan R, Huh J, Tiwari N, Sproat T, Camilleri-Brennan J. A prospective analysis of sleep deprivation and disturbance in surgical patients. Ann Med Surg (Lond). 2016 Jan 6;6:1-5. doi: 10.1016/j.amsu.2015.12.046. eCollection 2016 Mar. |
| 24237004 | Background | 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. |
| 28576285 | Background | 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. |
| 18580517 | Background | Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d. |
| 19106695 | Background | Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776. |
| 28403427 | Background | Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. |
| 22762316 | Background | Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923. |
| 18577850 | Background | Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24. |
| 19934879 | Background | 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. |
| 21857500 | Background | 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. |
| 16192770 | Background | Osman NI, Baghdoyan HA, Lydic R. Morphine inhibits acetylcholine release in rat prefrontal cortex when delivered systemically or by microdialysis to basal forebrain. Anesthesiology. 2005 Oct;103(4):779-87. doi: 10.1097/00000542-200510000-00016. |
| 19050611 | Background | Pisani MA, Murphy TE, Araujo KL, Slattum P, Van Ness PH, Inouye SK. Benzodiazepine and opioid use and the duration of intensive care unit delirium in an older population. Crit Care Med. 2009 Jan;37(1):177-83. doi: 10.1097/CCM.0b013e318192fcf9. |
| 11313076 | Background | Litaker D, Locala J, Franco K, Bronson DL, Tannous Z. Preoperative risk factors for postoperative delirium. Gen Hosp Psychiatry. 2001 Mar-Apr;23(2):84-9. doi: 10.1016/s0163-8343(01)00117-7. |
| 33939649 | Background | 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. |
| BG001 | Control | Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group.
Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants.
|
|
|
| Secondary | Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale | Visual Analogue Scale (mm, 0-100, 0 = no pain, 100 = worst pain imaginable) | Posted | Median | Inter-Quartile Range | score on a scale | 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 | Posted | Median | Inter-Quartile Range | score on a scale | 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) | Data at baseline or post-operative point was not available for some participants, so data is reported only for those who had complete baseline and post-operative data. | Posted | Median | Inter-Quartile Range | Minutes | 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) | Posted | Count of Participants | Participants | 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) | Data at baseline or post-operative point was not available for some participants, so data is reported only for those who had complete baseline and post-operative data. | Posted | Count of Participants | Participants | 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. | Data at baseline or post-operative point was not available for some participants, so data is reported only for those who had complete baseline and post-operative data. | Posted | Median | Inter-Quartile Range | score on a scale | 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) | Data at baseline or post-operative point was not available for some participants, so data is reported only for those who had complete baseline and post-operative data. | Posted | Median | Inter-Quartile Range | score on a scale | 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) | Data at baseline or post-operative point was not available for some participants, so data is reported only for those who had complete baseline and post-operative data. | Posted | Median | Inter-Quartile Range | score on a scale | 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). | Posted | Count of Participants | Participants | By afternoon of postoperative day (POD) 3 |
|
|
|
|
| Other Pre-specified | Caffeine Intake: Number of Caffeinated Beverages (n) Consumed | Number of caffeinated beverages (n) consumed | Not Posted | postoperative day 0-7 | Participants |
| Other Pre-specified | Subacute Opioid Consumption: Postoperative Subacute Opioid Consumption, Oral Morphine Equivalents (mg) | Postoperative subacute opioid consumption, oral morphine equivalents (mg) | Not Posted | postoperative days 4-7 | Participants |
| Other Pre-specified | Sleep Disturbances: Incidence (%) of New, Self-reported Sleep Disturbances | Incidence (%) of new, self-reported sleep disturbances | Not Posted | postoperative days 0-3 | Participants |
| Other Pre-specified | EEG Spectral Power: Spectral Power (dB) Measured on EEG | Spectral power (dB) measured on EEG | Not Posted | 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 | Participants |
| Other Pre-specified | EEG Connectivity: Connectivity (Weighted Phase Lag Index, wPLI) Measured on EEG | Connectivity (weighted phase lag index, wPLI) measured on EEG | Not Posted | 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 | Participants |
| Other Pre-specified | 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). | Not Posted | 30 days after surgery | Participants |
| Other Pre-specified | Persistent Opioid Use | Incidence of continued opioid use (%) on postoperative day (POD) 30 | Not Posted | Postoperative day (POD) 30 | Participants |
| Other Pre-specified | Quality of Recovery Survey | Self-report outcome measure evaluating recovery after surgery and anesthesia. Scoring ranges from 3-18, 3=poor 18=excellent | Not Posted | Postoperative day (POD) 1 | Participants |
| Other Pre-specified | Richards Campbell Sleep Questionnaire (RCSQ) | Self-report instrument for measuring sleep quality. Visual Analogue Scale (mm, 0-100, 0 =Deep sleep , 100 =Light sleep) | Richards Campbell Sleep Questionnaire (RCSQ) | Posted | Mean | Standard Deviation | score on a scale | Preoperative (once before surgery on day of surgery) |
|
|
|
| 0 |
| 33 |
| 2 |
| 33 |
| 8 |
| 33 |
| EG001 | Control | Prepared intravenous piggyback solution of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants who are randomized to this group. Dextrose Water: Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants. | 0 | 31 | 4 | 31 | 6 | 31 |
| Ileus requiring re-admittance to hospital | Gastrointestinal disorders | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Pelvic absess | Infections and infestations | Non-systematic Assessment |
|
| Hypoxia | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Nausea with emesis | General disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |