Trial Outcomes & Findings for Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery (NCT NCT03861988)
NCT ID: NCT03861988
Last Updated: 2023-10-05
Results Overview
The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups..
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
Post-intervention days 1, 2 and 3
Results posted on
2023-10-05
Participant Flow
For the open-label arm, recruitment occurred between August 2019 and March 2020. For the double-blind arms, recruitment occurred between February 2020 and August 2022. In all arms, recruitment occurred in medical clinics and by telephone and video visits.
Five participants were recruited for an open label study to evaluate and optimize study procedures prior to randomizing participants enrolled in the double-blind trial ("Double blind ketamine" vs "Double blind placebo").
Participant milestones
| Measure |
Open Label Ketamine
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
20
|
20
|
|
Overall Study
COMPLETED
|
5
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Baseline characteristics by cohort
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 18.9 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post-intervention days 1, 2 and 3Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups..
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Day 1
|
17.0 score on a scale
Standard Deviation 13.0
|
12.7 score on a scale
Standard Deviation 7.6
|
16.4 score on a scale
Standard Deviation 17.5
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Day 2
|
25.4 score on a scale
Standard Deviation 17.3
|
15.1 score on a scale
Standard Deviation 11.1
|
17.5 score on a scale
Standard Deviation 11.5
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Day 3
|
10.5 score on a scale
Standard Deviation 7.1
|
17.0 score on a scale
Standard Deviation 10.5
|
17.2 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 2 and 3Population: Includes all participants still enrolled in the trial
Clinical response defined as \>=50% reduction in MADRS score from baseline. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Number of Participants With Clinical Response
Day 1
|
2 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Clinical Response
Day 2
|
1 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Clinical Response
Day 3
|
3 Participants
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post-intervention day 14Remission defined as a MADRS score of \<=12 on day 14. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=19 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=19 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Number of Participants With Remission
|
3 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 2, 3, 5, 7 and 14Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
This outcome measures self-reported symptoms of anxiety and depression on a scale that ranges from 0 to 42. A lower score indicates lower severity of symptoms.
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Scale Score
Day 1
|
14.8 score on a scale
Standard Deviation 8.4
|
17.8 score on a scale
Standard Deviation 6.6
|
19.9 score on a scale
Standard Deviation 5.5
|
|
Hospital Anxiety and Depression Scale (HADS) Scale Score
Day 2
|
22.6 score on a scale
Standard Deviation 12.7
|
18.8 score on a scale
Standard Deviation 7.5
|
21.2 score on a scale
Standard Deviation 5.9
|
|
Hospital Anxiety and Depression Scale (HADS) Scale Score
Day 3
|
13.0 score on a scale
Standard Deviation 9.2
|
19.3 score on a scale
Standard Deviation 6.3
|
20.8 score on a scale
Standard Deviation 5.4
|
|
Hospital Anxiety and Depression Scale (HADS) Scale Score
Day 5
|
16.6 score on a scale
Standard Deviation 10.2
|
18.3 score on a scale
Standard Deviation 4.8
|
18.9 score on a scale
Standard Deviation 7.3
|
|
Hospital Anxiety and Depression Scale (HADS) Scale Score
Day 7
|
19.2 score on a scale
Standard Deviation 10.0
|
18.4 score on a scale
Standard Deviation 5.3
|
19.6 score on a scale
Standard Deviation 8.1
|
|
Hospital Anxiety and Depression Scale (HADS) Scale Score
Day 14
|
14.0 score on a scale
Standard Deviation 9.7
|
16.4 score on a scale
Standard Deviation 7.2
|
17.2 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 2, 3, 5, 7 and 14Population: In the open-label group, total opioid consumption was recorded only for the first 3 postoperative days
This outcome measures how many cumulative morphine-equivalents milligrams of opioid pain medication the patient has taken as an inpatient and after discharge from hospital
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Cumulative Opioid Use
Day 7
|
—
|
171.6 milligram morphine equivalents
Standard Deviation 219.0
|
163.3 milligram morphine equivalents
Standard Deviation 221.4
|
|
Cumulative Opioid Use
Day 14
|
—
|
206.1 milligram morphine equivalents
Standard Deviation 270.1
|
186.4 milligram morphine equivalents
Standard Deviation 242.3
|
|
Cumulative Opioid Use
Day 1
|
108.5 milligram morphine equivalents
Standard Deviation 72.2
|
60.9 milligram morphine equivalents
Standard Deviation 60.3
|
56.1 milligram morphine equivalents
Standard Deviation 61.5
|
|
Cumulative Opioid Use
Day 2
|
249.3 milligram morphine equivalents
Standard Deviation 173.2
|
104.6 milligram morphine equivalents
Standard Deviation 109.0
|
107.7 milligram morphine equivalents
Standard Deviation 126.3
|
|
Cumulative Opioid Use
Day 3
|
361.5 milligram morphine equivalents
Standard Deviation 237.3
|
137.9 milligram morphine equivalents
Standard Deviation 165.9
|
144.3 milligram morphine equivalents
Standard Deviation 188.4
|
|
Cumulative Opioid Use
Day 5
|
—
|
150.6 milligram morphine equivalents
Standard Deviation 204.3
|
156.2 milligram morphine equivalents
Standard Deviation 218.7
|
SECONDARY outcome
Timeframe: Average approximately 3 days post-interventionNumber of days from admission (day of surgery) through discharge after surgery.
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Hospital Length of Stay
|
3.7 days
Standard Deviation 0.9
|
1.9 days
Standard Deviation 1.7
|
4.0 days
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 2, 3, 5, 7 and 14Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
Average pain intensity in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing "No pain" and 10 representing "Pain as bad as you can imagine").
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Brief Pain Inventory Pain Intensity Scale Score
Day 1
|
4.6 score on a scale
Standard Deviation 1.8
|
6.0 score on a scale
Standard Deviation 2.0
|
5.2 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory Pain Intensity Scale Score
Day 2
|
5.5 score on a scale
Standard Deviation 2.5
|
5.3 score on a scale
Standard Deviation 2.1
|
6.0 score on a scale
Standard Deviation 2.3
|
|
Brief Pain Inventory Pain Intensity Scale Score
Day 3
|
3.5 score on a scale
Standard Deviation 3.0
|
5.5 score on a scale
Standard Deviation 1.9
|
5.2 score on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory Pain Intensity Scale Score
Day 5
|
4.4 score on a scale
Standard Deviation 2.3
|
5.5 score on a scale
Standard Deviation 1.7
|
4.4 score on a scale
Standard Deviation 2.3
|
|
Brief Pain Inventory Pain Intensity Scale Score
Day 7
|
4.8 score on a scale
Standard Deviation 2.4
|
5.1 score on a scale
Standard Deviation 2.2
|
4.4 score on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory Pain Intensity Scale Score
Day 14
|
4.4 score on a scale
Standard Deviation 3.0
|
4.8 score on a scale
Standard Deviation 1.5
|
3.7 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 2, 3, 5, 7 and 14Population: Missing data occurred when the number of participants analyzed on specific days was fewer than the overall number of participants analyzed. This situation arose when some participants did not complete the instrument.
Pain interference in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing "Does not interfere" and 10 representing "Completely interferes").
Outcome measures
| Measure |
Open Label Ketamine
n=5 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 Participants
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 Participants
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Brief Pain Inventory Pain Interference Scale Score
Day 1
|
6.0 units on a scale
Standard Deviation 2.7
|
8.1 units on a scale
Standard Deviation 2.6
|
7.6 units on a scale
Standard Deviation 3.2
|
|
Brief Pain Inventory Pain Interference Scale Score
Day 2
|
6.3 units on a scale
Standard Deviation 3.0
|
8.0 units on a scale
Standard Deviation 2.5
|
8.1 units on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory Pain Interference Scale Score
Day 3
|
4.8 units on a scale
Standard Deviation 2.2
|
7.5 units on a scale
Standard Deviation 2.6
|
7.7 units on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory Pain Interference Scale Score
Day 5
|
6.6 units on a scale
Standard Deviation 4.3
|
7.0 units on a scale
Standard Deviation 3.0
|
7.0 units on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory Pain Interference Scale Score
Day 7
|
7.6 units on a scale
Standard Deviation 3.8
|
6.7 units on a scale
Standard Deviation 2.8
|
7.2 units on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory Pain Interference Scale Score
Day 14
|
4.8 units on a scale
Standard Deviation 3.1
|
6.2 units on a scale
Standard Deviation 2.2
|
5.7 units on a scale
Standard Deviation 3.5
|
Adverse Events
Open Label Ketamine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Double Blind Ketamine
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Double Blind Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Ketamine
n=5 participants at risk
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 participants at risk
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 participants at risk
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Cardiac disorders
Acute pulmonary embolism
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
Other adverse events
| Measure |
Open Label Ketamine
n=5 participants at risk
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Ketamine
n=20 participants at risk
Patients received intravenous ketamine (0.5 mg/kg over 40 minutes) infusion during surgery.
|
Double Blind Placebo
n=20 participants at risk
Participants received placebo (normal saline infusion over 40 minutes) during surgery.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
10.0%
2/20 • Number of events 2 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Nervous system disorders
Uncontrolled muscle movement in fingers
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Surgical and medical procedures
IV site pain
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Surgical and medical procedures
Surgical revision of implanted neurostimulator
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Immune system disorders
Pruritis
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Nervous system disorders
Postoperative delirium
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
5.0%
1/20 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst
|
20.0%
1/5 • Number of events 1 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
0.00%
0/20 • Average approximately 19 days
Patients reported adverse events during follow-up assessments
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place