Trial Outcomes & Findings for Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion (NCT NCT01377623)
NCT ID: NCT01377623
Last Updated: 2017-07-11
Results Overview
The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Post-operative Day 3
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine Group (PFD)
Anesthesia maintained with propofol/fentanyl/dexmedetomidine
|
Placebo Group (PFS)
Anesthesia maintained with propofol/fentanyl/saline
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
Baseline characteristics by cohort
| Measure |
Placebo Group
n=28 Participants
Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
|
Dexmedetomidine Group
n=26 Participants
Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
56.18 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-operative Day 3The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Outcome measures
| Measure |
Dexmedetomidine Group (PFD)
n=26 Participants
Anesthesia maintained with propofol/fentanyl/dexmedetomidine
|
Placebo Group (PFS)
n=28 Participants
Anesthesia maintained with propofol/fentanyl/saline
|
|---|---|---|
|
Quality of Recovery Score (QoR-40)
|
183.04 units on a scale
Standard Deviation 2.76
|
169.3 units on a scale
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: Post-operative Day 1Outcome measures
| Measure |
Dexmedetomidine Group (PFD)
n=26 Participants
Anesthesia maintained with propofol/fentanyl/dexmedetomidine
|
Placebo Group (PFS)
n=28 Participants
Anesthesia maintained with propofol/fentanyl/saline
|
|---|---|---|
|
Concentration of TNF-alpha
|
10.1 pg/ml
Interval 3.8 to 12.7
|
7.9 pg/ml
Interval 2.1 to 11.4
|
SECONDARY outcome
Timeframe: Post-operative Day 1Outcome measures
| Measure |
Dexmedetomidine Group (PFD)
n=26 Participants
Anesthesia maintained with propofol/fentanyl/dexmedetomidine
|
Placebo Group (PFS)
n=28 Participants
Anesthesia maintained with propofol/fentanyl/saline
|
|---|---|---|
|
Concentration of IL-1a
|
2.52 pg/ml
Interval 1.4 to 3.6
|
2.58 pg/ml
Interval 1.4 to 2.6
|
SECONDARY outcome
Timeframe: Post-operative Day 1Outcome measures
| Measure |
Dexmedetomidine Group (PFD)
n=26 Participants
Anesthesia maintained with propofol/fentanyl/dexmedetomidine
|
Placebo Group (PFS)
n=28 Participants
Anesthesia maintained with propofol/fentanyl/saline
|
|---|---|---|
|
Concentration of IL-6
|
60.8 pg/ml
Interval 27.3 to 122.8
|
50.0 pg/ml
Interval 11.2 to 82.1
|
SECONDARY outcome
Timeframe: Post-operative Day 1Outcome measures
| Measure |
Dexmedetomidine Group (PFD)
n=26 Participants
Anesthesia maintained with propofol/fentanyl/dexmedetomidine
|
Placebo Group (PFS)
n=28 Participants
Anesthesia maintained with propofol/fentanyl/saline
|
|---|---|---|
|
Concentration of IL-8
|
20.9 pg/ml
Interval 12.6 to 31.2
|
16.4 pg/ml
Interval 6.2 to 24.6
|
Adverse Events
Dexmedetomidine Group (PFD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group (PFS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place