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Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia as well as as an analgesic. It has been shown to have anti-inflammatory properties which may decrease post-operative complications following cardiac surgery with cardiopulmonary bypass that are thought to associated with inflammation. Some studies have shown that ketamine does decrease these complications when compared with anesthetics that are not commonly used in our cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication which is used for induction of anesthesia. Ketamine has not been compared with propofol for potential to reduce post-operative complications associated with the inflammatory process. This study aims to see if ketamine will reduce the incidence of cognitive dysfunction, delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic impact of ketamine compared propofol will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketamine | Active Comparator | Ketamine induction |
|
| Propofol | Active Comparator | Propofol induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine used for induction |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Postoperative Cognitive Dysfunction | 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. | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Acute Kidney Injury | 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. | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. |
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Scheduled to undergo cardiac surgery.
Inclusion criteria:
Exclusion criteria will include:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Wittwer, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Of the 265 patients assessed for eligibility, 52 were randomized to study groups. 8 did not meet inclusion criteria, 97 declined to participate, 96 were unable to be contacted before surgery, and 12 were unable to coordinate preoperative testing before surgery.
Participants who were undergoing complex cardiac surgery at Mayo Clinic were recruited between August 2015 and October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Ketamine induction Ketamine: Ketamine used for induction |
| FG001 | Propofol | Propofol induction Propofol: Propofol for induction |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
52 patients were enrolled. 3 patients did not complete the study. 1 patient was found to be ineligible after enrollment, 1 patient transitioned to a procedure that was in the exclusion criteria, and one patient received both the induction medications. This resulted in 25 patients for analysis in the ketamine group and 24 patients in the Propofol group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Ketamine induction Ketamine: Ketamine used for induction |
| BG001 | Propofol | Propofol induction Propofol: Propofol used for induction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients With Postoperative Cognitive Dysfunction | 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. | Intent to treat population | Posted | Count of Participants | Participants | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. |
|
Surgery to discharge, up to 10 days postoperatively
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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 | Ketamine | Ketamine induction Ketamine: Ketamine used for induction | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complete heart block | Cardiac disorders | Systematic Assessment |
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Not powered to detect differences in acute kidney injury. A larger study will be needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erica Wittwer | Mayo Clinic | 5072559814 | wittwer.erica@mayo.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 | Aug 9, 2017 | Sep 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003693 | Delirium |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003221 | Confusion |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Propofol for induction |
|
|
| Number of Patients Who Develop Postoperative Delirium | 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. | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. |
| received both drugs |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Trail Making Test A | Activity tests visual attention & task switching. Subjects connect 25 dots in numerical order as quickly and accurately as possible. Raw scores converted z-scores using published references. Z-score of zero corresponds to the mean score (time taken) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (longer time, worse performance) and a score less than zero indicates a value below the mean (shorter time, better performance). 1.5 or 2 SD from mean is usually considered impaired | Mean | Standard Deviation | Z score |
|
| Trail Making Test B | Activity tests visual attention & task switching. Subjects connect 25 dots in numerical order as quickly and accurately as possible. Raw scores converted z-scores using published references. Z-score of zero corresponds to the mean score (time taken) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (longer time, worse performance) and a score less than zero indicates a value below the mean (shorter time, better performance). 1.5 or 2 SD from mean is usually considered impaired | Mean | Standard Deviation | Z score |
|
| Hopkins Verbal Learning Test-Revised (HVLT-R) Learning Trials test | This activity tests the subject's ability to remember a list of 25 words read to the subject. This tests immediate recall of the words. Z-scores: the raw scores were converted z-scores using published references. Z-score of zero corresponds to the mean score (words recalled) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (indicates better performance) and a score less than zero indicates a value below the mean (worse performance). | Mean | Standard Deviation | Z score |
|
| Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall | This activity tests the subject's ability to remember a list of 25 words 20-25 min after these words were previously read to the subject. Z-scores: the raw scores were converted z-scores using published references. Z-score of zero corresponds to the mean score (words recalled) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (indicates better performance) and a score less than zero indicates a value below the mean (worse performance). | Mean | Standard Deviation | Z score |
|
| Hopkins Verbal Learning Test-Revised (HVLT-R) Digit Span | This activity tests the subject's ability to remember a list of numbers after the list is read to them. They are asked to repeat the numbers back in the same order presented. Z-scores: the raw scores were converted z-scores using published references. Z-score of zero corresponds to the mean score (words recalled) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (indicates better performance) and a score less than zero indicates a value below the mean (worse performance). | Mean | Standard Deviation | Z score |
|
| Controlled Oral Word Association Test (COWAT) | This activity tests the subject's verbal fluency. They are given a category and asked to say as many words from that category as possible in a set timeframe. Z-scores: the raw scores were converted z-scores using published references. Z-score of zero corresponds to the mean score (words recalled) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (indicates better performance) and a score less than zero indicates a value below the mean (worse performance). | Mean | Standard Deviation | Z score |
|
| Stroop color/word test | This tests the subject's ability to name the color a word is printed in when the word is the name of a different color. Example: Red printed in green ink, the answer is green. Z-scores: the raw scores were converted z-scores using published references. Z-score of zero corresponds to the mean score (words recalled) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (indicates better performance) and a score less than zero indicates a value below the mean (worse performance). | Mean | Standard Deviation | Z score |
|
| Mini-Mental Status Exam | This 11 question exam tests multiple aspects of cognitive function including orientation, attention, memory, language, and visual spatial skills and only takes a few minutes. Z-scores: the raw scores were converted z-scores using published references. Z-score of zero corresponds to the mean score (words recalled) in the reference population. Z-score of 1 indicates a value that is one standard deviation from the mean. A z-score greater than zero indicates a value above the mean (indicates better performance) and a score less than zero indicates a value below the mean (worse performance). | Mean | Standard Deviation | Z score |
|
| OG001 | Propofol | Propofol induction Propofol: Propofol for induction |
|
|
|
| Secondary | Number of Patients With Acute Kidney Injury | 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. | Intent to treat | Posted | Count of Participants | Participants | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. |
|
|
|
|
| Secondary | Number of Patients Who Develop Postoperative Delirium | 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. | Posted | Count of Participants | Participants | Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. |
|
|
|
|
| 25 |
| 1 |
| 25 |
| 0 |
| 25 |
| EG001 | Propofol | Propofol induction Propofol: Propofol used for induction | 0 | 24 | 1 | 24 | 0 | 24 |
| RV failure | Cardiac disorders | Systematic Assessment | Post bypass right ventricular failure requiring IABP |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory failure one week post op requiring reintubation |
|
| Intestinal perforation | Gastrointestinal disorders | Systematic Assessment | Ileus and intestinal perforation requiring surgery |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |