Trial Outcomes & Findings for The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery (NCT NCT03054857)
NCT ID: NCT03054857
Last Updated: 2018-06-19
Results Overview
POCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
48 hours
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
Dex Group
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
|
Placebo Group
The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Dex Group
n=49 Participants
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
|
Placebo Group
n=50 Participants
The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.43 years
STANDARD_DEVIATION 13.077 • n=99 Participants
|
52.72 years
STANDARD_DEVIATION 10.975 • n=107 Participants
|
52.08 years
STANDARD_DEVIATION 12.017 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
49 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Weight
|
60.88 kilograms
STANDARD_DEVIATION 12.5 • n=99 Participants
|
62.69 kilograms
STANDARD_DEVIATION 11.81 • n=107 Participants
|
61.794 kilograms
STANDARD_DEVIATION 12.128 • n=206 Participants
|
|
BMI
|
23.08 Kilograms per metre square
STANDARD_DEVIATION 3.09 • n=99 Participants
|
26.19 Kilograms per metre square
STANDARD_DEVIATION 19.21 • n=107 Participants
|
24.65 Kilograms per metre square
STANDARD_DEVIATION 13.8424 • n=206 Participants
|
|
Left Ventricular Ejection Fraction
|
62.26 percentage of left ventricular ejection
STANDARD_DEVIATION 11.53 • n=99 Participants
|
63.27 percentage of left ventricular ejection
STANDARD_DEVIATION 11.55 • n=107 Participants
|
62.7717 percentage of left ventricular ejection
STANDARD_DEVIATION 11.48959 • n=206 Participants
|
|
Serum Creatinine
|
0.94 miligram per decilitre
STANDARD_DEVIATION 0.24 • n=99 Participants
|
0.95 miligram per decilitre
STANDARD_DEVIATION 0.27 • n=107 Participants
|
0.9445 miligram per decilitre
STANDARD_DEVIATION 0.25329 • n=206 Participants
|
|
Operation type
CABG
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Operation type
Single valve surgery
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Operation type
Multiple valve surgery
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Operation type
CABG with valve surgery
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Operative Time
|
301.73 minutes
STANDARD_DEVIATION 87.70 • n=99 Participants
|
309.28 minutes
STANDARD_DEVIATION 79.97 • n=107 Participants
|
305.55 minutes
STANDARD_DEVIATION 83.541 • n=206 Participants
|
|
Cardiopulmonary Bypass Time
|
120.59 minutes
STANDARD_DEVIATION 41.52 • n=99 Participants
|
132.34 minutes
STANDARD_DEVIATION 46.55 • n=107 Participants
|
126.53 minutes
STANDARD_DEVIATION 44.299 • n=206 Participants
|
|
Aortic Cross-clamp Time
|
92.69 minutes
STANDARD_DEVIATION 34.03 • n=99 Participants
|
99.88 minutes
STANDARD_DEVIATION 38.38 • n=107 Participants
|
96.32 minutes
STANDARD_DEVIATION 36.287 • n=206 Participants
|
|
Diabetes Mellitus
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Hypertension
|
22 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Atrial fibrillation
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Baseline Montreal Cognitive Assessment scores (0-30 points)
|
22.84 points
STANDARD_DEVIATION 4.464 • n=99 Participants
|
22.88 points
STANDARD_DEVIATION 3.707 • n=107 Participants
|
22.86 points
STANDARD_DEVIATION 4.078 • n=206 Participants
|
|
Baseline Short Blessed Test score (0-28 points)
|
4.98 points
STANDARD_DEVIATION 4.922 • n=99 Participants
|
5.30 points
STANDARD_DEVIATION 5.754 • n=107 Participants
|
5.14 points
STANDARD_DEVIATION 5.334 • n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPOCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.
Outcome measures
| Measure |
Dex Group
n=49 Participants
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation
|
Placebo Group
n=50 Participants
The control group received a loading dose and continuous IV infusion of normal saline at the same rate
|
|---|---|---|
|
Numbers of Participants With Postoperative Cognitive Dysfunction (POCD)
|
12 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 7 daysPOCD was defined as a decline of 1SD of baseline score in either MoCA test or short bless test.
Outcome measures
| Measure |
Dex Group
n=49 Participants
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation
|
Placebo Group
n=50 Participants
The control group received a loading dose and continuous IV infusion of normal saline at the same rate
|
|---|---|---|
|
Number of Participants With Postoperative Cognitive Dysfunction (POCD)
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7 daysNeurological complication, Delirium, dysrhythmia, death
Outcome measures
| Measure |
Dex Group
n=49 Participants
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation
|
Placebo Group
n=50 Participants
The control group received a loading dose and continuous IV infusion of normal saline at the same rate
|
|---|---|---|
|
Number of Participants With Postoperative Complications
Postoperative delirium
|
0 Participants
|
1 Participants
|
|
Number of Participants With Postoperative Complications
Embolic Stroke
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Dex Group
n=49 Participants
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation
|
Placebo Group
n=50 Participants
The control group received a loading dose and continuous IV infusion of normal saline at the same rate
|
|---|---|---|
|
Hospital Stay in Days
|
9.367 days
Standard Deviation 3.604
|
10.42 days
Standard Deviation 4.248
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Dex Group
n=49 Participants
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation
|
Placebo Group
n=50 Participants
The control group received a loading dose and continuous IV infusion of normal saline at the same rate
|
|---|---|---|
|
ICU Stay in Hours
|
33.79 hours
Standard Deviation 36.43
|
38.44 hours
Standard Deviation 39.17
|
Adverse Events
Dex Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dex Group
n=49 participants at risk
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
|
Placebo Group
n=50 participants at risk
The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular events
|
0.00%
0/49 • 7 days
|
2.0%
1/50 • Number of events 1 • 7 days
|
Other adverse events
| Measure |
Dex Group
n=49 participants at risk
After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
|
Placebo Group
n=50 participants at risk
The control group received a loading dose and continuous IV infusion of normal saline at the same rate.
|
|---|---|---|
|
Cardiac disorders
dysrhythmia
|
26.5%
13/49 • Number of events 13 • 7 days
|
22.0%
11/50 • Number of events 11 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place