The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
NCT02554253, Phase 2, Completed, Mayo Clinic; results first posted 2022-02-15
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction | ClinicalTrials.gov |
| NCT number | NCT02554253 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 52 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Mayo Clinic | ClinicalTrials.gov |
| Conditions | Cognitive Disorders, Delirium, Acute Kidney Injury | ClinicalTrials.gov |
| Interventions | Ketamine, Propofol | ClinicalTrials.gov |
| First posted | 2015-09-18 | ClinicalTrials.gov |
| Last updated | 2022-02-15 | ClinicalTrials.gov |
| Results first posted | 2022-02-15 | ClinicalTrials.gov |
| Limitations and caveats | Not powered to detect differences in acute kidney injury. A larger study will be needed. | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Patients With Postoperative Cognitive Dysfunction | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. | Pre and postoperative cognitive studies will be performed to assess change in cognitive function. Postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests. The neurocognitive tests utilized include Trail making Test A, Trail making Test B, Hopkins Verbal Learning Test-Revised Learning trials, Hopkins Verbal Learning Test-Revised Delayed Recall, Digit Span, Controlled Oral Word Association Test, Stroop color/word test, and the Mini Mental Status Examination. | ClinicalTrials.gov |
| Secondary | Number of Patients With Acute Kidney Injury | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. | AKI was defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria including an increase in serum creatinine ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, and urine output \< 0.5 mL/kg/hr for 6 hours. | ClinicalTrials.gov |
| Secondary | Number of Patients Who Develop Postoperative Delirium | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. | Delirium was defined as a positive CAM (Confusion assessment method) score. CAM score was recorded every 12 hours postoperatively as per routine. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4. The score is either positive or negative. Positive means the patient has delirium and negative indicates the patient is not delirious. | ClinicalTrials.gov |
Outcomes 3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Postoperative Cognitive Dysfunction | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Number of Patients With Acute Kidney Injury | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. | Intent to treat | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Number of Patients Who Develop Postoperative Delirium | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Number of Patients With Postoperative Cognitive Dysfunction | Ketamine | 16 | Participants | ClinicalTrials.gov | ||
| Number of Patients With Postoperative Cognitive Dysfunction | Propofol | 10 | Participants | ClinicalTrials.gov | ||
| Number of Patients With Acute Kidney Injury | Ketamine | 6 | Participants | ClinicalTrials.gov | ||
| Number of Patients With Acute Kidney Injury | Propofol | 12 | Participants | ClinicalTrials.gov | ||
| Number of Patients Who Develop Postoperative Delirium | Ketamine | 0 | Participants | ClinicalTrials.gov | ||
| Number of Patients Who Develop Postoperative Delirium | Propofol | 1 | Participants | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Ketamine | 26 | ClinicalTrials.gov | |
| Overall Study | STARTED | Propofol | 26 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Ketamine | 25 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Propofol | 24 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Ketamine | 1 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Propofol | 2 | ClinicalTrials.gov |
Adverse events 10
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 | Source |
|---|---|---|---|---|---|---|---|
| serious | Complete heart block | Cardiac disorders | Ketamine | 0 | 25 | 0 | ClinicalTrials.gov |
| serious | Complete heart block | Cardiac disorders | Propofol | 1 | 24 | 1 | ClinicalTrials.gov |
| serious | RV failure | Cardiac disorders | Ketamine | 1 | 25 | 1 | ClinicalTrials.gov |
| serious | RV failure | Cardiac disorders | Propofol | 0 | 24 | 0 | ClinicalTrials.gov |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Ketamine | 1 | 25 | 1 | ClinicalTrials.gov |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Propofol | 0 | 24 | 0 | ClinicalTrials.gov |
| serious | Intestinal perforation | Gastrointestinal disorders | Ketamine | 1 | 25 | 1 | ClinicalTrials.gov |
| serious | Intestinal perforation | Gastrointestinal disorders | Propofol | 0 | 24 | 0 | ClinicalTrials.gov |
| serious | Acute kidney injury | Renal and urinary disorders | Ketamine | 1 | 25 | 1 | ClinicalTrials.gov |
| serious | Acute kidney injury | Renal and urinary disorders | Propofol | 0 | 24 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Ketamine | 0 | 25 | ClinicalTrials.gov |
| Total, all-cause mortality | Propofol | 0 | 24 | ClinicalTrials.gov |
| Total, other adverse events | Ketamine | 0 | 25 | ClinicalTrials.gov |
| Total, other adverse events | Propofol | 0 | 24 | ClinicalTrials.gov |
| Total, serious adverse events | Ketamine | 1 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | Propofol | 1 | 24 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketamine vs Propofol: Number of Patients With Acute Kidney Injury | Trial comparisons |
| Ketamine vs Propofol: Number of Patients With Postoperative Cognitive Dysfunction | Trial comparisons |
| Ketamine vs Propofol: Number of Patients Who Develop Postoperative Delirium | Trial comparisons |
| Ketamine vs Propofol: deaths from any cause | Trial comparisons |
| Ketamine vs Propofol: serious adverse events | Trial comparisons |
Tests 6
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 |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)