Trial Outcomes & Findings for Ketamine In Thoracic Surgery (KITS) Trial (NCT NCT00504725)
NCT ID: NCT00504725
Last Updated: 2014-07-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
24 Hours
Results posted on
2014-07-25
Participant Flow
Participant milestones
| Measure |
Ketamine
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
0.9 % saline bolus of equivalent volume
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ketamine
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
0.9 % saline bolus of equivalent volume
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Ketamine In Thoracic Surgery (KITS) Trial
Baseline characteristics by cohort
| Measure |
Ketamine
n=21 Participants
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
n=20 Participants
0.9 % saline bolus of equivalent volume
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
AGE
|
61 Years
STANDARD_DEVIATION 12 • n=99 Participants
|
66 Years
STANDARD_DEVIATION 10 • n=107 Participants
|
63 Years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 HoursOutcome measures
| Measure |
Ketamine
n=20 Participants
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
n=20 Participants
0.9 % saline bolus of equivalent volume
|
|---|---|---|
|
Interleukin Levels at 24 Hours
Interleukin-6 (IL-6)
|
245 pg/ml
Standard Deviation 287
|
269 pg/ml
Standard Deviation 210
|
|
Interleukin Levels at 24 Hours
Interleukin-8 (IL-8)
|
11.3 pg/ml
Standard Deviation 12.6
|
14.8 pg/ml
Standard Deviation 10.8
|
|
Interleukin Levels at 24 Hours
Interleukin-10 (IL-10)
|
3.0 pg/ml
Standard Deviation 4.7
|
4.9 pg/ml
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 24 hoursThe CRP levels were measured 24 hours postoperatively.
Outcome measures
| Measure |
Ketamine
n=20 Participants
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
n=20 Participants
0.9 % saline bolus of equivalent volume
|
|---|---|---|
|
C-reactive Protein (CRP) Serum Levels
|
8.8 pg/ml
Standard Deviation 4.5
|
9.3 pg/ml
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: baseline, 4 hours, 24 hours and at dischargePain scores rated by the subject on a scale of 0 low - 10 high
Outcome measures
| Measure |
Ketamine
n=20 Participants
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
n=20 Participants
0.9 % saline bolus of equivalent volume
|
|---|---|---|
|
Verbal Pain Scores
Baseline
|
0.30 units on a scale
Standard Deviation 0.73
|
0.35 units on a scale
Standard Deviation 1.35
|
|
Verbal Pain Scores
4 Hours
|
3.8 units on a scale
Standard Deviation 2.1
|
3.1 units on a scale
Standard Deviation 2.8
|
|
Verbal Pain Scores
24 Hours
|
2.6 units on a scale
Standard Deviation 2.2
|
2.8 units on a scale
Standard Deviation 2.1
|
|
Verbal Pain Scores
Discharge
|
1.8 units on a scale
Standard Deviation 2.5
|
1.1 units on a scale
Standard Deviation 1.8
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=20 participants at risk
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
|
Placebo
n=20 participants at risk
0.9 % saline bolus of equivalent volume
|
|---|---|---|
|
Cardiac disorders
AF
|
15.0%
3/20 • Number of events 3
|
15.0%
3/20 • Number of events 3
|
|
Surgical and medical procedures
CHEST TUBE PLACEMENT
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place