Trial Outcomes & Findings for Dexmedetomidine and Delirium in Patients After Cardiac Surgery (NCT NCT02267538)
NCT ID: NCT02267538
Last Updated: 2018-03-05
Results Overview
Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
285 participants
Primary outcome timeframe
During the first five days after surgery
Results posted on
2018-03-05
Participant Flow
Participant milestones
| Measure |
DEX Group
participant who received dexmedetomidine
|
CTRL Group
participants who recieved normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
143
|
|
Overall Study
COMPLETED
|
142
|
143
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
Baseline characteristics by cohort
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 5.4 • n=142 Participants
|
67.5 years
STANDARD_DEVIATION 5.3 • n=143 Participants
|
66.9 years
STANDARD_DEVIATION 5.4 • n=285 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=142 Participants
|
41 Participants
n=143 Participants
|
88 Participants
n=285 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=142 Participants
|
102 Participants
n=143 Participants
|
197 Participants
n=285 Participants
|
|
Body Mass Index "kg/m^2"
|
25.3 kg/m^2
STANDARD_DEVIATION 3.4 • n=142 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 2.8 • n=143 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 3.1 • n=285 Participants
|
|
Education (year)
|
9 years
n=142 Participants
|
9 years
n=143 Participants
|
9 years
n=285 Participants
|
|
Hypertension
|
89 Participants
n=142 Participants
|
91 Participants
n=143 Participants
|
180 Participants
n=285 Participants
|
|
Arrhythmia
|
32 Participants
n=142 Participants
|
29 Participants
n=143 Participants
|
61 Participants
n=285 Participants
|
|
Stroke
|
26 Participants
n=142 Participants
|
33 Participants
n=143 Participants
|
59 Participants
n=285 Participants
|
|
Chronic Obstructive Ppulmonary Disease
|
7 Participants
n=142 Participants
|
4 Participants
n=143 Participants
|
11 Participants
n=285 Participants
|
|
Diabetes Mellitus
|
43 Participants
n=142 Participants
|
49 Participants
n=143 Participants
|
92 Participants
n=285 Participants
|
|
Hyperlipidemia
|
38 Participants
n=142 Participants
|
61 Participants
n=143 Participants
|
99 Participants
n=285 Participants
|
|
Chronic kidney disease
|
1 Participants
n=142 Participants
|
7 Participants
n=143 Participants
|
8 Participants
n=285 Participants
|
|
Tumor
|
7 Participants
n=142 Participants
|
3 Participants
n=143 Participants
|
10 Participants
n=285 Participants
|
|
Thyroid disease
|
4 Participants
n=142 Participants
|
3 Participants
n=143 Participants
|
7 Participants
n=285 Participants
|
|
Smoking
|
51 Participants
n=142 Participants
|
66 Participants
n=143 Participants
|
117 Participants
n=285 Participants
|
|
Acute myocardial infarction
|
17 Participants
n=142 Participants
|
11 Participants
n=143 Participants
|
28 Participants
n=285 Participants
|
|
Calcium Channel Blocker
|
33 Participants
n=142 Participants
|
45 Participants
n=143 Participants
|
78 Participants
n=285 Participants
|
|
Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers
|
50 Participants
n=142 Participants
|
46 Participants
n=143 Participants
|
96 Participants
n=285 Participants
|
|
β-blocker
|
63 Participants
n=142 Participants
|
66 Participants
n=143 Participants
|
129 Participants
n=285 Participants
|
|
Statins
|
63 Participants
n=142 Participants
|
75 Participants
n=143 Participants
|
138 Participants
n=285 Participants
|
|
Antiplatelet drugs
|
85 Participants
n=142 Participants
|
82 Participants
n=143 Participants
|
167 Participants
n=285 Participants
|
|
European System for Cardiac Operative Risk Evaluation
|
3 units on a scale
n=142 Participants
|
3 units on a scale
n=143 Participants
|
3 units on a scale
n=285 Participants
|
|
History of surgery
|
55 Participants
n=142 Participants
|
52 Participants
n=143 Participants
|
107 Participants
n=285 Participants
|
|
History of general anesthesia
|
24 Participants
n=142 Participants
|
24 Participants
n=143 Participants
|
48 Participants
n=285 Participants
|
|
New York Heart Association (NYHA) Functional Classification
I
|
2 Participants
n=125 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
2 Participants
n=132 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
4 Participants
n=257 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
|
New York Heart Association (NYHA) Functional Classification
II
|
87 Participants
n=125 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
92 Participants
n=132 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
179 Participants
n=257 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
|
New York Heart Association (NYHA) Functional Classification
III
|
33 Participants
n=125 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
36 Participants
n=132 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
69 Participants
n=257 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
|
New York Heart Association (NYHA) Functional Classification
IV
|
3 Participants
n=125 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
2 Participants
n=132 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
5 Participants
n=257 Participants • 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class
|
|
left ventricular ejection fraction (LVEF)%
|
64.4 percentage
n=142 Participants
|
64.8 percentage
n=143 Participants
|
64.7 percentage
n=285 Participants
|
|
the American Society of Anesthesiologists (ASA) Classification
II
|
1 Participants
n=142 Participants
|
2 Participants
n=143 Participants
|
3 Participants
n=285 Participants
|
|
the American Society of Anesthesiologists (ASA) Classification
III
|
128 Participants
n=142 Participants
|
129 Participants
n=143 Participants
|
257 Participants
n=285 Participants
|
|
the American Society of Anesthesiologists (ASA) Classification
IV
|
13 Participants
n=142 Participants
|
12 Participants
n=143 Participants
|
25 Participants
n=285 Participants
|
|
Mini-Mental State Examination（MMSE）score
|
29 units on a scale
n=142 Participants
|
29 units on a scale
n=143 Participants
|
29 units on a scale
n=285 Participants
|
|
Hospital Anxiety and Depression Scale score
|
8 units on a scale
n=142 Participants
|
8 units on a scale
n=143 Participants
|
8 units on a scale
n=285 Participants
|
|
Barthe Index(BI)score
|
100 units on a scale
n=142 Participants
|
100 units on a scale
n=143 Participants
|
100 units on a scale
n=285 Participants
|
|
Delirium
|
0 Participants
n=142 Participants
|
0 Participants
n=143 Participants
|
0 Participants
n=285 Participants
|
PRIMARY outcome
Timeframe: During the first five days after surgeryDelirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery.
Outcome measures
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
|---|---|---|
|
Incidence of Postoperative Delirium
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: on the sixth day after surgery, and on the 30th day after surgeryPopulation: 5 patients (3 in CTRL group and 2 in DEX group) did not complete the MMSE test on postoperative day 6;17 patients (12 in CTRL group and 5 in DEX group) did not complete the m-TICS test on postoperative day 30
Cognitive function was assessed with the Mini Mental State Examination (MMSE) at baseline (the day before surgery) and on the sixth day after surgery, and with modified telephone interview for cognitive status (m-TICS) on the 30th day after surgery. The introduction of MMSE scale has been explained in the baseline part in the result section. The Telephone Interview for Cognitive Status-modified scale(m-TICS) is one of the most popular telephone interview-based screening instruments for mild cognitive impairment and dementia. It consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis, which score ranges from 0 to 48, with higher scores indicating better cognitive function
Outcome measures
| Measure |
DEX Group
n=140 Participants
participant who received dexmedetomidine
|
CTRL Group
n=140 Participants
participants who recieved normal saline
|
|---|---|---|
|
Cognitive Function
m-TICS score on postoperative day 30
|
34 units on a scale
Interval 32.0 to 37.0
|
34 units on a scale
Interval 32.0 to 36.0
|
|
Cognitive Function
MMSE score on postoperative day 6
|
29 units on a scale
Interval 27.0 to 30.0
|
29 units on a scale
Interval 27.0 to 30.0
|
SECONDARY outcome
Timeframe: Occurrence of non-delirium complications will be monitored until 30 days after surgery.Non-delirium complications was defined as any conditions other than delirium that occurred during the first 30 days after surgery and required therapeutic intervention.Complications listed here were not considered adverse events in this study.
Outcome measures
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
|---|---|---|
|
Incidence of Non-delirium Complications After Surgery
Wound dehiscence or infection
|
11 Participants
|
7 Participants
|
|
Incidence of Non-delirium Complications After Surgery
Acute kidney injury
|
37 Participants
|
44 Participants
|
|
Incidence of Non-delirium Complications After Surgery
IABP assistance
|
6 Participants
|
12 Participants
|
|
Incidence of Non-delirium Complications After Surgery
Stroke
|
3 Participants
|
3 Participants
|
|
Incidence of Non-delirium Complications After Surgery
New onset arrythmia
|
42 Participants
|
51 Participants
|
|
Incidence of Non-delirium Complications After Surgery
Pulmonary complications
|
15 Participants
|
27 Participants
|
|
Incidence of Non-delirium Complications After Surgery
Upper gastrointestinal bleeding
|
2 Participants
|
4 Participants
|
|
Incidence of Non-delirium Complications After Surgery
Surgical bleeding
|
3 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the first five days after surgeryPain intensity was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = no pain, 10 = the worst possible pain).
Outcome measures
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
|---|---|---|
|
Pain Intensity
Pain score after surgery(d1), at rest
|
3 units on a scale
Interval 1.0 to 5.0
|
3 units on a scale
Interval 2.0 to 5.0
|
|
Pain Intensity
Pain score after surgery(d2), at rest
|
4 units on a scale
Interval 2.0 to 5.0
|
3 units on a scale
Interval 2.0 to 5.0
|
|
Pain Intensity
Pain score after surgery(d3), at rest
|
3 units on a scale
Interval 2.0 to 4.0
|
2 units on a scale
Interval 2.0 to 4.0
|
|
Pain Intensity
Pain score after surgery(d4), at rest
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
|
Pain Intensity
Pain score after surgery(d5), at rest
|
2 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 2.0
|
|
Pain Intensity
Pain score after surgery(d1), with coughing
|
4 units on a scale
Interval 2.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
|
Pain Intensity
Pain score after surgery(d2), with coughing
|
5 units on a scale
Interval 3.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
|
Pain Intensity
Pain score after surgery(d3), with coughing
|
4 units on a scale
Interval 3.0 to 5.0
|
4 units on a scale
Interval 2.0 to 5.0
|
|
Pain Intensity
Pain score after surgery(d4), with coughing
|
3 units on a scale
Interval 2.0 to 4.0
|
3 units on a scale
Interval 2.0 to 4.0
|
|
Pain Intensity
Pain score after surgery(d5), with coughing
|
2 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 2.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the first five days after surgerySubjective sleep quality was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = best sleep, 10 = the worst possible sleep).
Outcome measures
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
|---|---|---|
|
Subjective Sleep Quality
Subjective sleep quality after surgery(d5), score
|
2 units on a scale
Interval 0.0 to 3.0
|
2 units on a scale
Interval 0.0 to 2.0
|
|
Subjective Sleep Quality
Subjective sleep quality after surgery(d2), score
|
3 units on a scale
Interval 2.0 to 6.0
|
3 units on a scale
Interval 2.0 to 6.0
|
|
Subjective Sleep Quality
Subjective sleep quality after surgery(d1), score
|
2 units on a scale
Interval 0.0 to 5.0
|
2 units on a scale
Interval 0.0 to 6.0
|
|
Subjective Sleep Quality
Subjective sleep quality after surgery(d3), score
|
2 units on a scale
Interval 2.0 to 5.0
|
2 units on a scale
Interval 2.0 to 4.0
|
|
Subjective Sleep Quality
Subjective sleep quality after surgery(d4), score
|
2 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 0.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of surgery until discharge from Intensive Care Unit or 30 days after surgeryResults was presented as median (95% confidence interval).
Outcome measures
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
|---|---|---|
|
Length of Stay in the Intensive Care Unit
|
45.0 hours
Interval 43.5 to 46.5
|
46.0 hours
Interval 44.8 to 47.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of surgery until discharge from hospital or 30 days after surgeryResults was presented as median (95% confidence interval).
Outcome measures
| Measure |
DEX Group
n=142 Participants
participant who received dexmedetomidine
|
CTRL Group
n=143 Participants
participants who recieved normal saline
|
|---|---|---|
|
Length of Stay in Hospital After Surgery
|
9 days
Interval 8.0 to 10.0
|
9 days
Interval 8.0 to 10.0
|
Adverse Events
DEX Group
Serious events: 0 serious events
Other events: 38 other events
Deaths: 2 deaths
CTRL Group
Serious events: 0 serious events
Other events: 40 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DEX Group
n=142 participants at risk
participant who received dexmedetomidine
|
CTRL Group
n=143 participants at risk
participants who recieved normal saline
|
|---|---|---|
|
Cardiac disorders
Intraoperative Bradycardia
|
14.8%
21/142 • Number of events 21 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
9.8%
14/143 • Number of events 14 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
|
Vascular disorders
Intraoperative Hypotension
|
7.0%
10/142 • Number of events 10 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
7.0%
10/143 • Number of events 10 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
|
Cardiac disorders
Postoperative Bradycardia
|
1.4%
2/142 • Number of events 2 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
4.2%
6/143 • Number of events 6 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
|
Vascular disorders
Postoperative Hypotension
|
3.5%
5/142 • Number of events 5 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
7.0%
10/143 • Number of events 10 • From the start of study drug infusion until 24 hours after the end of study drug infusion.
|
Additional Information
Dr. Dong-Xin Wang,PHD,the director of department of Anesthesiology and Critical Care Medicine
Peking University First Hospital
Phone: +8613910731903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place