Trial Outcomes & Findings for Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial (NCT NCT05233566)
NCT ID: NCT05233566
Last Updated: 2026-08-21
Results Overview
The numerator will include all patients who are randomized to receive either ketamine or placebo. The denominator will include all patients who are approached by the research team to evaluated eligibility and offer consent.
COMPLETED
PHASE3
32 participants
3 days after surgery
2026-08-21
Participant Flow
Participant milestones
| Measure |
Ketamine Arm
Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes.
Ketamine: NMDA antagonist
|
Control Arm
Following surgery and extubation, patients will receive normal saline at an equal rate to that used in the ketamine arm.
Normal saline: IV fluid acting as a placebo
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial
Baseline characteristics by cohort
| Measure |
Ketamine Arm
n=16 Participants
Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes.
Ketamine: NMDA antagonist
|
Control Arm
n=16 Participants
Following surgery and extubation, patients will receive normal saline at an equal rate to that used in the ketamine arm.
Normal saline: IV fluid acting as a placebo
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 years
n=5 Participants
|
48.5 years
n=109 Participants
|
47.9 years
n=133 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=109 Participants
|
26 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
6 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=109 Participants
|
32 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=109 Participants
|
29 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Preoperative Depressive Symptoms - Montgomery-Asberg Depression Rating Scale
0-6 (No symptoms)
|
3 Participants
n=5 Participants
|
5 Participants
n=109 Participants
|
8 Participants
n=133 Participants
|
|
Preoperative Depressive Symptoms - Montgomery-Asberg Depression Rating Scale
7-19 (Mild symptoms)
|
6 Participants
n=5 Participants
|
5 Participants
n=109 Participants
|
11 Participants
n=133 Participants
|
|
Preoperative Depressive Symptoms - Montgomery-Asberg Depression Rating Scale
20-34 (Moderate symptoms)
|
6 Participants
n=5 Participants
|
5 Participants
n=109 Participants
|
11 Participants
n=133 Participants
|
|
Preoperative Depressive Symptoms - Montgomery-Asberg Depression Rating Scale
35-60 (Severe symptoms)
|
1 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 3 days after surgeryPopulation: The analysis population for this outcome includes all patients who were approached by the research team, including those who decided not to participate in the trial and those who were excluded from the trial prior to randomization. Because these patients were never randomized, it is not possible to report results for this outcome separately for the Ketamine Arm and the Control Arm.
The numerator will include all patients who are randomized to receive either ketamine or placebo. The denominator will include all patients who are approached by the research team to evaluated eligibility and offer consent.
Outcome measures
| Measure |
Protocol Version 1
n=27 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=101 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Approached Patients Who Enroll and Are Randomized
|
1 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 3 days after surgeryThe numerator will include all participants who received the entire study medication infusion as planned. The denominator will include all participants who are randomized to receive either ketamine or the placebo.
Outcome measures
| Measure |
Protocol Version 1
n=16 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=16 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Randomized Patients Who Complete the Study Infusion
|
15 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 14 days after the interventionDepression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The numerator will include all patients with MADRS scores documented at all 6 time points. The denominator will include all participants who are randomized to receive either ketamine or the placebo.
Outcome measures
| Measure |
Protocol Version 1
n=16 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=16 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points
|
13 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 days after the interventionPopulation: Excludes participants with missing MADRS scores either at baseline or on post-infusion day 4.
Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The distribution of MADRS scores in the population will be assessed for normality using visual analysis of histograms and using the Kolmogorov-Smirnoff test. If the MADRS scores are normally distributed, then the mean scores in the two groups on post-infusion day 4 will be compared using linear regression, adjusting for preoperative score. If the MADRS scores are not normally distributed, then the median delta scores in the two groups will be compared using median regression, adjusting for preoperative score. Participants with missing MADRS scores at either time point (preoperative baseline or post-infusion day 4) will be excluded.
Outcome measures
| Measure |
Protocol Version 1
n=13 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=11 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Depressive Symptoms on Day 4
|
4 score on a scale
Interval 2.0 to 16.0
|
6 score on a scale
Interval 3.5 to 12.0
|
SECONDARY outcome
Timeframe: 2 days after interventionElectroencephalograms (EEG) will be captured during sleep using the Dreem headband (DREEM, Rhythm, New York, NY), a consumer-grade wireless device using dry electrodes. Sleep stages (e.g., non-rapid eye movement \[NREM\], rapid eye movement, wakefulness) will be detected using the Dreem headband's built-in automated sleep scoring algorithm. During each time epoch, slow wave activity will be defined as the EEG power in the range 1-4 Hz. The delta sleep ratio (DSR) will be defined as the ratio of slow wave activity during the first NREM epoch to slow wave activity during the second NREM epoch. Because it is a ratio, the DSR is a dimensionless number. In normal sleep, slow wave activity is greatest at the beginning of the night and decreases throughout the night. Therefore, higher DSR values reflect a more normal sleep architecture.
Outcome measures
| Measure |
Protocol Version 1
n=2 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=3 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Delta Sleep Ratio on Night 1 Following Study Medication
|
3.01 ratio (dimensionless number)
Interval 2.99 to 3.03
|
0.96 ratio (dimensionless number)
Interval 0.2 to 1.63
|
SECONDARY outcome
Timeframe: 2 days after interventionPopulation: Data were stratified by sex.
NIH-required analysis. Electroencephalograms (EEG) will be captured during sleep using the Dreem headband (DREEM, Rhythm, New York, NY), a consumer-grade wireless device using dry electrodes. Sleep stages (e.g., non-rapid eye movement \[NREM\], rapid eye movement, wakefulness) will be detected using the Dreem headband's built-in automated sleep scoring algorithm. During each time epoch, slow wave activity will be defined as the EEG power in the range 1-4 Hz. The delta sleep ratio (DSR) will be defined as the ratio of slow wave activity during the first NREM epoch to slow wave activity during the second NREM epoch. Because it is a ratio, the DSR is a dimensionless number. In normal sleep, slow wave activity is greatest at the beginning of the night and decreases throughout the night. Therefore, higher DSR values reflect a more normal sleep architecture.
Outcome measures
| Measure |
Protocol Version 1
n=2 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=3 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Delta Sleep Ratio on Night 1 Following Study Medication - Stratified by Sex
Female
|
3.03 ratio (dimensionless number)
Interval 3.03 to 3.03
|
0.96 ratio (dimensionless number)
Interval 0.2 to 1.63
|
|
Delta Sleep Ratio on Night 1 Following Study Medication - Stratified by Sex
Male
|
2.99 ratio (dimensionless number)
Interval 2.99 to 2.99
|
—
|
SECONDARY outcome
Timeframe: 2 days after interventionPopulation: Data were stratified by race.
NIH-required analysis. Electroencephalograms (EEG) will be captured during sleep using the Dreem headband (DREEM, Rhythm, New York, NY), a consumer-grade wireless device using dry electrodes. Sleep stages (e.g., non-rapid eye movement \[NREM\], rapid eye movement, wakefulness) will be detected using the Dreem headband's built-in automated sleep scoring algorithm. During each time epoch, slow wave activity will be defined as the EEG power in the range 1-4 Hz. The delta sleep ratio (DSR) will be defined as the ratio of slow wave activity during the first NREM epoch to slow wave activity during the second NREM epoch. Because it is a ratio, the DSR is a dimensionless number. In normal sleep, slow wave activity is greatest at the beginning of the night and decreases throughout the night. Therefore, higher DSR values reflect a more normal sleep architecture.
Outcome measures
| Measure |
Protocol Version 1
n=2 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=3 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Delta Sleep Ratio on Night 1 Following Study Medication - Stratified by Race
More than One Race
|
—
|
1.04 ratio (dimensionless number)
Interval 1.04 to 1.04
|
|
Delta Sleep Ratio on Night 1 Following Study Medication - Stratified by Race
White
|
3.01 ratio (dimensionless number)
Interval 2.99 to 3.03
|
0.92 ratio (dimensionless number)
Interval 0.29 to 1.63
|
POST_HOC outcome
Timeframe: 3 days after surgeryPopulation: The analysis population for this outcome includes all patients who were approached by the research team, including those who decided not to participate in the trial and those who were excluded from the trial prior to randomization. Because these patients were never randomized, it is not possible to report results for this outcome separately for the Ketamine Arm and the Control Arm. Data were stratified by sex.
NIH-required analysis. The numerator will include all patients who are randomized to receive either ketamine or placebo. The denominator will include all patients who are approached by the research team to evaluated eligibility and offer consent.
Outcome measures
| Measure |
Protocol Version 1
n=27 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=101 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Approached Patients Who Enroll and Are Randomized - Stratified by Sex
Female
|
1 Participants
|
25 Participants
|
|
Fraction of Approached Patients Who Enroll and Are Randomized - Stratified by Sex
Male
|
0 Participants
|
6 Participants
|
POST_HOC outcome
Timeframe: 3 days after surgeryPopulation: The analysis population for this outcome includes all patients who were approached by the research team, including those who decided not to participate in the trial and those who were excluded from the trial prior to randomization. Because these patients were never randomized, it is not possible to report results for this outcome separately for the Ketamine Arm and the Control Arm. Data were stratified by race.
NIH-required analysis. The numerator will include all patients who are randomized to receive either ketamine or placebo. The denominator will include all patients who are approached by the research team to evaluated eligibility and offer consent.
Outcome measures
| Measure |
Protocol Version 1
n=27 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=101 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Approached Patients Who Enroll and Are Randomized - Stratified by Race
More than One Race
|
0 Participants
|
1 Participants
|
|
Fraction of Approached Patients Who Enroll and Are Randomized - Stratified by Race
American Indian or Alaska Native
|
—
|
1 Participants
|
|
Fraction of Approached Patients Who Enroll and Are Randomized - Stratified by Race
Black or African American
|
—
|
1 Participants
|
|
Fraction of Approached Patients Who Enroll and Are Randomized - Stratified by Race
White
|
1 Participants
|
28 Participants
|
POST_HOC outcome
Timeframe: 3 days after surgeryPopulation: Data were stratified by sex.
NIH-required analysis. The numerator will include all participants who received the entire study medication infusion as planned. The denominator will include all participants who are randomized to receive either ketamine or the placebo.
Outcome measures
| Measure |
Protocol Version 1
n=16 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=16 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Randomized Patients Who Complete the Study Infusion - Stratified by Sex
Female
|
10 Participants
|
14 Participants
|
|
Fraction of Randomized Patients Who Complete the Study Infusion - Stratified by Sex
Male
|
5 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: 3 days after surgeryPopulation: Data were stratified by race.
NIH-required analysis. The numerator will include all participants who received the entire study medication infusion as planned. The denominator will include all participants who are randomized to receive either ketamine or the placebo.
Outcome measures
| Measure |
Protocol Version 1
n=16 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=16 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Randomized Patients Who Complete the Study Infusion - Stratified by Race
American Indian or Alaska Native
|
1 Participants
|
—
|
|
Fraction of Randomized Patients Who Complete the Study Infusion - Stratified by Race
Black or African American
|
—
|
1 Participants
|
|
Fraction of Randomized Patients Who Complete the Study Infusion - Stratified by Race
More than One Race
|
—
|
1 Participants
|
|
Fraction of Randomized Patients Who Complete the Study Infusion - Stratified by Race
White
|
14 Participants
|
13 Participants
|
POST_HOC outcome
Timeframe: 14 days after the interventionPopulation: Data were stratified by sex.
NIH-required analysis. Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The numerator will include all patients with MADRS scores documented at all 6 time points. The denominator will include all participants who are randomized to receive either ketamine or the placebo.
Outcome measures
| Measure |
Protocol Version 1
n=16 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=16 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points - Stratified by Sex
Female
|
10 Participants
|
6 Participants
|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points - Stratified by Sex
Male
|
3 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: 14 days after the interventionPopulation: Data were stratified by race.
NIH-required analysis. Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The numerator will include all patients with MADRS scores documented at all 6 time points. The denominator will include all participants who are randomized to receive either ketamine or the placebo.
Outcome measures
| Measure |
Protocol Version 1
n=16 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=16 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points - Stratified by Race
American Indian or Alaska Native
|
1 Participants
|
—
|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points - Stratified by Race
Black or African American
|
—
|
0 Participants
|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points - Stratified by Race
More than One Race
|
—
|
1 Participants
|
|
Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points - Stratified by Race
White
|
12 Participants
|
5 Participants
|
POST_HOC outcome
Timeframe: 4 days after the interventionPopulation: Excludes participants with missing MADRS scores either at baseline or on post-infusion day 4. Data were stratified by sex.
NIH-required analysis. Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The distribution of MADRS scores in the population will be assessed for normality using visual analysis of histograms and using the Kolmogorov-Smirnoff test. If the MADRS scores are normally distributed, then the mean scores in the two groups on post-infusion day 4 will be compared using linear regression, adjusting for preoperative score. If the MADRS scores are not normally distributed, then the median delta scores in the two groups will be compared using median regression, adjusting for preoperative score. Participants with missing MADRS scores at either time point (preoperative baseline or post-infusion day 4) will be excluded.
Outcome measures
| Measure |
Protocol Version 1
n=13 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=11 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Depressive Symptoms on Day 4 - Stratified by Sex
Female
|
4 score on a scale
Interval 2.0 to 16.0
|
7 score on a scale
Interval 4.0 to 13.0
|
|
Depressive Symptoms on Day 4 - Stratified by Sex
Male
|
3.5 score on a scale
Interval 2.0 to 11.0
|
1 score on a scale
Interval 1.0 to 1.0
|
POST_HOC outcome
Timeframe: 4 days after the interventionPopulation: Excludes participants with missing MADRS scores either at baseline or on post-infusion day 4. Data were stratified by race.
NIH-required analysis. Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The distribution of MADRS scores in the population will be assessed for normality using visual analysis of histograms and using the Kolmogorov-Smirnoff test. If the MADRS scores are normally distributed, then the mean scores in the two groups on post-infusion day 4 will be compared using linear regression, adjusting for preoperative score. If the MADRS scores are not normally distributed, then the median delta scores in the two groups will be compared using median regression, adjusting for preoperative score. Participants with missing MADRS scores at either time point (preoperative baseline or post-infusion day 4) will be excluded.
Outcome measures
| Measure |
Protocol Version 1
n=13 Participants
Under protocol version 1, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing surgery at Barnes-Jewish Hospital with planned ICU admission.
|
Protocol Version 2
n=11 Participants
Under protocol version 2, the inclusion criteria included patients aged ≥18 yr with a history of depression undergoing non-ambulatory surgery scheduled for at least 2 h.
|
|---|---|---|
|
Depressive Symptoms on Day 4 - Stratified by Race
American Indian or Alaska Native
|
16 score on a scale
Interval 16.0 to 16.0
|
—
|
|
Depressive Symptoms on Day 4 - Stratified by Race
More than One Race
|
—
|
14 score on a scale
Interval 14.0 to 14.0
|
|
Depressive Symptoms on Day 4 - Stratified by Race
White
|
3.5 score on a scale
Interval 2.0 to 11.0
|
6 score on a scale
Interval 3.0 to 11.0
|
Adverse Events
Control Arm
Ketamine Arm
Serious adverse events
| Measure |
Control Arm
n=16 participants at risk
Following surgery and extubation, patients will receive normal saline at an equal rate to that used in the ketamine arm.
Normal saline: IV fluid acting as a placebo
|
Ketamine Arm
n=16 participants at risk
Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes.
Ketamine: NMDA antagonist
|
|---|---|---|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
Nervous system disorders
Ramsay Hunt syndrome
|
0.00%
0/16 • 30 days
|
6.2%
1/16 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Postoperative Apnea
|
0.00%
0/16 • 30 days
|
6.2%
1/16 • 30 days
|
|
Nervous system disorders
Subjective arm/leg weakness
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
Infections and infestations
Surgical Site Infection
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
Blood and lymphatic system disorders
Deep Venous Thrombosis
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
General disorders
Death (underlying etiology unable to be determined)
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
Other adverse events
| Measure |
Control Arm
n=16 participants at risk
Following surgery and extubation, patients will receive normal saline at an equal rate to that used in the ketamine arm.
Normal saline: IV fluid acting as a placebo
|
Ketamine Arm
n=16 participants at risk
Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes.
Ketamine: NMDA antagonist
|
|---|---|---|
|
Nervous system disorders
Transient Ischemic Attack
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
Skin and subcutaneous tissue disorders
Blisters around incision
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
General disorders
Fever and chills
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
|
Gastrointestinal disorders
Nausea and vomiting
|
6.2%
1/16 • 30 days
|
0.00%
0/16 • 30 days
|
Additional Information
Dr. Bradley Fritz
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place