Trial · NCT03577730
Caffeine and Neurologic Recovery Following Surgery and General Anesthesia
NCT03577730, Early phase 1, Completed, University of Michigan; results first posted 2021-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Caffeine and Neurologic Recovery Following Surgery and General Anesthesia. Trials, record NCT03577730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03577730
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caffeine and Neurologic Recovery Following Surgery and General Anesthesia
- NCT number
- NCT03577730
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 71 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Pain, Postoperative
- Interventions
- Caffeine Citrate, Dextrose Water
- First posted
- 2018-07-05
- Last updated
- 2021-10-06
- Results first posted
- 2021-10-06
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | through postoperative day 3 | Postoperative opioid consumption, oral morphine equivalents (mg) |
| Secondary | Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale | Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol. | Visual Analogue Scale (mm, 0-100, 0 = no pain, 100 = worst pain imaginable) |
| Secondary | Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale | Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol. | Behavioral Pain Scale, on a scale ranging from 3 to 12 when 3 is no pain and 12 is maximum pain |
| Secondary | Time Until Anesthetic Emergence | Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes | Time from surgical dressing on to anesthetic emergence (min) |
| Secondary | Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) | baseline through postoperative day 3 | 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) |
| Secondary | Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A) | baseline through postoperative day 3 | 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) |
| Secondary | Cognitive Function as Assessed by Trail Making Test | morning of surgery baseline compared to postanesthesia care unit. Postanesthesia care unit measurement approximately 60 minutes after end of surgery | 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. |
| Secondary | Positive Affect as Assessed by PANAS (Positive and Negative Affect Schedule) | postoperative day 3 | Positive Affect Score (n, 10-50, 10 = least positive affect, 50 = most positive affect) via PANAS (Positive and Negative Affect Schedule) |
| Secondary | Negative Affect as Assessed by PANAS (Positive and Negative Affect Schedule) | postoperative day 3 | Negative Affect Score (n, 10-50, 10 = least negative affect, 50 = most negative affect) via PANAS (Positive and Negative Affect Schedule) |
| Secondary | Percentage of Delirious Patients Per Group | By afternoon of postoperative day (POD) 3 | 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). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | through postoperative day 3 | oral morphine equivalents (mg) | MEDIAN | |
| SECONDARY | Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale | Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol. | score on a scale | MEDIAN | |
| SECONDARY | Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale | Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol. | score on a scale | MEDIAN | |
| SECONDARY | Time Until Anesthetic Emergence | Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes | 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. | Minutes | MEDIAN |
| SECONDARY | Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) | baseline through postoperative day 3 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A) | baseline through postoperative day 3 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cognitive Function as Assessed by Trail Making Test | morning of surgery baseline compared to postanesthesia care unit. Postanesthesia care unit measurement approximately 60 minutes after end of surgery | 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. | score on a scale | MEDIAN |
| SECONDARY | Positive Affect as Assessed by PANAS (Positive and Negative Affect Schedule) | postoperative day 3 | 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. | score on a scale | MEDIAN |
| SECONDARY | Negative Affect as Assessed by PANAS (Positive and Negative Affect Schedule) | postoperative day 3 | 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. | score on a scale | MEDIAN |
| SECONDARY | Percentage of Delirious Patients Per Group | By afternoon of postoperative day (POD) 3 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | Experimental | 77 | Inter-Quartile Range 33 to 182 | oral morphine equivalents (mg) | |
| Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg) | Control | 51 | Inter-Quartile Range 15 to 117 | oral morphine equivalents (mg) | |
| Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale | Experimental | 40 | Inter-Quartile Range 19 to 65 | score on a scale | |
| Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale | Control | 39 | Inter-Quartile Range 18 to 60 | score on a scale | |
| Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale | Experimental | 3 | Inter-Quartile Range 3 to 3 | score on a scale | |
| Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale | Control | 3 | Inter-Quartile Range 3 to 3 | score on a scale | |
| Time Until Anesthetic Emergence | Experimental | 8 | Inter-Quartile Range 6 to 15 | Minutes | |
| Time Until Anesthetic Emergence | Control | 10 | Inter-Quartile Range 6 to 17 | Minutes | |
| Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) | Experimental | 2 | Participants | ||
| Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) | Control | 1 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental | 34 | |
| Overall Study | STARTED | Control | 31 | |
| Overall Study | Received Treatment | Experimental | 33 | |
| Overall Study | Received Treatment | Control | 31 | |
| Overall Study | COMPLETED | Experimental | 30 | |
| Overall Study | COMPLETED | Control | 30 | |
| Overall Study | NOT COMPLETED | Experimental | 4 | |
| Overall Study | NOT COMPLETED | Control | 1 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ileus | Gastrointestinal disorders | Experimental | 5 | 33 | 5 |
| other | Ileus | Gastrointestinal disorders | Control | 0 | 31 | 0 |
| other | Nausea | General disorders | Experimental | 3 | 33 | 3 |
| other | Nausea | General disorders | Control | 0 | 31 | 0 |
| other | Nausea with emesis | General disorders | Experimental | 0 | 33 | 0 |
| other | Nausea with emesis | General disorders | Control | 4 | 31 | 4 |
| other | Dehydration | General disorders | Experimental | 0 | 33 | 0 |
| other | Dehydration | General disorders | Control | 2 | 31 | 2 |
| serious | Acute kidney injury | Renal and urinary disorders | Experimental | 0 | 33 | 0 |
| serious | Acute kidney injury | Renal and urinary disorders | Control | 1 | 31 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental | 0 | 33 |
| Total, all-cause mortality | Control | 0 | 31 |
| Total, other adverse events | Experimental | 8 | 33 |
| Total, other adverse events | Control | 6 | 31 |
| Total, serious adverse events | Experimental | 2 | 33 |
| Total, serious adverse events | Control | 4 | 31 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental vs Control: Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A) | Trial comparisons |
| Experimental vs Control: Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D) | Trial comparisons |
| Experimental vs Control: Percentage of Delirious Patients Per Group | Trial comparisons |
| Experimental vs Control: deaths from any cause | Trial comparisons |
| Experimental vs Control: serious adverse events | Trial comparisons |
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03577730
GET https://conductscience.org/api/trials/v1/NCT03577730/results?page=2