Trial Outcomes & Findings for Dexmedetomidine-ketamine in Femur Proximal Fracture Patients (NCT NCT02150759)
NCT ID: NCT02150759
Last Updated: 2019-04-29
Results Overview
We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
average 10-20 minutes
Results posted on
2019-04-29
Participant Flow
from May 2014 to October 2016
Participant milestones
| Measure |
Dexmedetomidine-ketamine
Dexmedetomidine-ketamine group
Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia
Ketamine: add dexmedetomidine during position change
|
Dexmedetomidine-fentanyl
Dexmedetomidine-fentanyl group
Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia
Fentanyl: add dexmedetomidine during position change
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Baseline characteristics by cohort
| Measure |
Dexmedetomidine-Ketamine
n=22 Participants
Dexmedetomidine-Ketamine combination
|
Dexmedetomidine-Fentanyl
n=21 Participants
Dexmedetomidine-Fentanyl combination
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.28 years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
79.57 years
STANDARD_DEVIATION 7.13 • n=7 Participants
|
78.90 years
STANDARD_DEVIATION 6.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
weight
|
52.22 kg
STANDARD_DEVIATION 8.67 • n=5 Participants
|
55.79 kg
STANDARD_DEVIATION 8.15 • n=7 Participants
|
53.96 kg
STANDARD_DEVIATION 8.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: average 10-20 minutesWe want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.
Outcome measures
| Measure |
Dexmedetomidine-ketamine
n=22 Participants
Dexmedetomidine-ketamine group
Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia
Ketamine: add dexmedetomidine during position change
|
Dexmedetomidine-fentanyl
n=21 Participants
Dexmedetomidine-fentanyl group
Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia
Fentanyl: add dexmedetomidine during position change
|
|---|---|---|
|
Pain Score Using Five Scales
Lateral position · 0
|
15 Participants
|
0 Participants
|
|
Pain Score Using Five Scales
Lateral position · 1
|
5 Participants
|
0 Participants
|
|
Pain Score Using Five Scales
Lateral position · 2
|
2 Participants
|
5 Participants
|
|
Pain Score Using Five Scales
Lateral position · 3
|
0 Participants
|
16 Participants
|
|
Pain Score Using Five Scales
Lateral position · 4
|
0 Participants
|
0 Participants
|
|
Pain Score Using Five Scales
Hip flexion · 0
|
17 Participants
|
1 Participants
|
|
Pain Score Using Five Scales
Hip flexion · 1
|
3 Participants
|
0 Participants
|
|
Pain Score Using Five Scales
Hip flexion · 2
|
1 Participants
|
6 Participants
|
|
Pain Score Using Five Scales
Hip flexion · 3
|
1 Participants
|
14 Participants
|
|
Pain Score Using Five Scales
Hip flexion · 4
|
0 Participants
|
0 Participants
|
|
Pain Score Using Five Scales
Spinal blodk · 0
|
17 Participants
|
11 Participants
|
|
Pain Score Using Five Scales
Spinal blodk · 1
|
2 Participants
|
8 Participants
|
|
Pain Score Using Five Scales
Spinal blodk · 2
|
3 Participants
|
2 Participants
|
|
Pain Score Using Five Scales
Spinal blodk · 3
|
0 Participants
|
0 Participants
|
|
Pain Score Using Five Scales
Spinal blodk · 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: average 10-20 minutes during spinal anesthesiaWe estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.
Outcome measures
| Measure |
Dexmedetomidine-ketamine
n=22 Participants
Dexmedetomidine-ketamine group
Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia
Ketamine: add dexmedetomidine during position change
|
Dexmedetomidine-fentanyl
n=21 Participants
Dexmedetomidine-fentanyl group
Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia
Fentanyl: add dexmedetomidine during position change
|
|---|---|---|
|
Quality of Patient Positioning
Spinal block · 2
|
6 Participants
|
5 Participants
|
|
Quality of Patient Positioning
Lateral position · 0
|
2 Participants
|
3 Participants
|
|
Quality of Patient Positioning
Lateral position · 1
|
3 Participants
|
15 Participants
|
|
Quality of Patient Positioning
Lateral position · 2
|
9 Participants
|
3 Participants
|
|
Quality of Patient Positioning
Lateral position · 3
|
8 Participants
|
0 Participants
|
|
Quality of Patient Positioning
Hip flexion · 0
|
3 Participants
|
5 Participants
|
|
Quality of Patient Positioning
Hip flexion · 1
|
6 Participants
|
13 Participants
|
|
Quality of Patient Positioning
Hip flexion · 2
|
5 Participants
|
3 Participants
|
|
Quality of Patient Positioning
Hip flexion · 3
|
8 Participants
|
0 Participants
|
|
Quality of Patient Positioning
Spinal block · 0
|
1 Participants
|
3 Participants
|
|
Quality of Patient Positioning
Spinal block · 1
|
7 Participants
|
13 Participants
|
|
Quality of Patient Positioning
Spinal block · 3
|
8 Participants
|
0 Participants
|
Adverse Events
Dexmedetomidine-Ketamine
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Dexmedetomidine-Fentanyl
Serious events: 1 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dexmedetomidine-Ketamine
n=22 participants at risk
Dexmedetomidine-Ketamine combination
|
Dexmedetomidine-Fentanyl
n=21 participants at risk
Dexmedetomidine-Fentanyl combination
|
|---|---|---|
|
Cardiac disorders
postoperative cardiopulmonary resuscitation
|
0.00%
0/22 • 1 week
|
4.8%
1/21 • Number of events 1 • 1 week
|
Other adverse events
| Measure |
Dexmedetomidine-Ketamine
n=22 participants at risk
Dexmedetomidine-Ketamine combination
|
Dexmedetomidine-Fentanyl
n=21 participants at risk
Dexmedetomidine-Fentanyl combination
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
81.8%
18/22 • Number of events 18 • 1 week
|
66.7%
14/21 • Number of events 14 • 1 week
|
|
Cardiac disorders
Hypotension
|
95.5%
21/22 • Number of events 21 • 1 week
|
95.2%
20/21 • Number of events 20 • 1 week
|
|
Respiratory, thoracic and mediastinal disorders
desaturation
|
81.8%
18/22 • Number of events 18 • 1 week
|
66.7%
14/21 • Number of events 14 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place