Trial Outcomes & Findings for The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction (NCT NCT02554253)
NCT ID: NCT02554253
Last Updated: 2022-02-15
Results Overview
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.
COMPLETED
PHASE2
52 participants
Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.
2022-02-15
Participant Flow
Participants who were undergoing complex cardiac surgery at Mayo Clinic were recruited between August 2015 and October 2019.
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.
Participant milestones
| Measure |
Ketamine
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
Propofol induction
Propofol: Propofol for induction
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ketamine
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
Propofol induction
Propofol: Propofol for induction
|
|---|---|---|
|
Overall Study
ineligible after enrollment
|
1
|
0
|
|
Overall Study
converted to transcatheter procedure
|
0
|
1
|
|
Overall Study
received both drugs
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ketamine
n=25 Participants
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
n=24 Participants
Propofol induction
Propofol: Propofol used for induction
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.4 years
STANDARD_DEVIATION 3.5 • n=25 Participants
|
76.1 years
STANDARD_DEVIATION 5.3 • n=24 Participants
|
76.3 years
STANDARD_DEVIATION 4.4 • n=49 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=25 Participants
|
10 Participants
n=24 Participants
|
19 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=25 Participants
|
14 Participants
n=24 Participants
|
30 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
49 Participants
n=49 Participants
|
|
Trail Making Test A
|
-0.1 Z score
STANDARD_DEVIATION 0.8 • n=25 Participants
|
0 Z score
STANDARD_DEVIATION 1.1 • n=24 Participants
|
0.0 Z score
STANDARD_DEVIATION 1.0 • n=49 Participants
|
|
Trail Making Test B
|
0.2 Z score
STANDARD_DEVIATION 1.0 • n=25 Participants
|
-0.1 Z score
STANDARD_DEVIATION 1.1 • n=24 Participants
|
0.1 Z score
STANDARD_DEVIATION 1.1 • n=49 Participants
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Learning Trials test
|
-0.7 Z score
STANDARD_DEVIATION 0.9 • n=25 Participants
|
-0.5 Z score
STANDARD_DEVIATION 0.8 • n=24 Participants
|
-0.6 Z score
STANDARD_DEVIATION 0.9 • n=49 Participants
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall
|
-0.9 Z score
STANDARD_DEVIATION 1.3 • n=25 Participants
|
-0.8 Z score
STANDARD_DEVIATION 1.2 • n=24 Participants
|
-0.9 Z score
STANDARD_DEVIATION 1.2 • n=49 Participants
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Digit Span
|
0.2 Z score
STANDARD_DEVIATION 0.8 • n=25 Participants
|
0.1 Z score
STANDARD_DEVIATION 1.0 • n=24 Participants
|
0.2 Z score
STANDARD_DEVIATION 0.9 • n=49 Participants
|
|
Controlled Oral Word Association Test (COWAT)
|
0.1 Z score
STANDARD_DEVIATION 0.8 • n=25 Participants
|
0.1 Z score
STANDARD_DEVIATION 0.8 • n=24 Participants
|
0.1 Z score
STANDARD_DEVIATION 0.8 • n=49 Participants
|
|
Stroop color/word test
|
-0.3 Z score
STANDARD_DEVIATION 1.0 • n=25 Participants
|
-0.6 Z score
STANDARD_DEVIATION 1.3 • n=24 Participants
|
-0.4 Z score
STANDARD_DEVIATION 1.1 • n=49 Participants
|
|
Mini-Mental Status Exam
|
0.7 Z score
STANDARD_DEVIATION 0.9 • n=25 Participants
|
0.4 Z score
STANDARD_DEVIATION 1.1 • n=24 Participants
|
0.6 Z score
STANDARD_DEVIATION 1.0 • n=49 Participants
|
PRIMARY outcome
Timeframe: Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.Population: Intent to treat population
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.
Outcome measures
| Measure |
Ketamine
n=25 Participants
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
n=24 Participants
Propofol induction
Propofol: Propofol for induction
|
|---|---|---|
|
Number of Patients With Postoperative Cognitive Dysfunction
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.Population: Intent to treat
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.
Outcome measures
| Measure |
Ketamine
n=25 Participants
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
n=24 Participants
Propofol induction
Propofol: Propofol for induction
|
|---|---|---|
|
Number of Patients With Acute Kidney Injury
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ketamine
n=25 Participants
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
n=24 Participants
Propofol induction
Propofol: Propofol for induction
|
|---|---|---|
|
Number of Patients Who Develop Postoperative Delirium
|
0 Participants
|
1 Participants
|
Adverse Events
Ketamine
Propofol
Serious adverse events
| Measure |
Ketamine
n=25 participants at risk
Ketamine induction
Ketamine: Ketamine used for induction
|
Propofol
n=24 participants at risk
Propofol induction
Propofol: Propofol used for induction
|
|---|---|---|
|
Cardiac disorders
Complete heart block
|
0.00%
0/25 • Surgery to discharge, up to 10 days postoperatively
|
4.2%
1/24 • Number of events 1 • Surgery to discharge, up to 10 days postoperatively
|
|
Cardiac disorders
RV failure
|
4.0%
1/25 • Number of events 1 • Surgery to discharge, up to 10 days postoperatively
|
0.00%
0/24 • Surgery to discharge, up to 10 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • Surgery to discharge, up to 10 days postoperatively
|
0.00%
0/24 • Surgery to discharge, up to 10 days postoperatively
|
|
Gastrointestinal disorders
Intestinal perforation
|
4.0%
1/25 • Number of events 1 • Surgery to discharge, up to 10 days postoperatively
|
0.00%
0/24 • Surgery to discharge, up to 10 days postoperatively
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • Number of events 1 • Surgery to discharge, up to 10 days postoperatively
|
0.00%
0/24 • Surgery to discharge, up to 10 days postoperatively
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place