Trial Outcomes & Findings for Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve (NCT NCT00561678)
NCT ID: NCT00561678
Last Updated: 2018-04-23
Results Overview
Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
404 participants
Primary outcome timeframe
Day 1
Results posted on
2018-04-23
Participant Flow
Trial was conducted at 10 sites from February 2008 to May 2014. The lead site was The Mount Sinai Hospital in New York City.
Participant milestones
| Measure |
Precedex
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Overall Study
STARTED
|
197
|
207
|
|
Overall Study
COMPLETED
|
189
|
201
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Precedex
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
surgery cancelled
|
1
|
1
|
|
Overall Study
surgery rescheduled to different site
|
2
|
2
|
|
Overall Study
anesthesia provider refusal
|
1
|
0
|
Baseline Characteristics
Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve
Baseline characteristics by cohort
| Measure |
Precedex
n=189 Participants
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 Participants
Placebo - normal saline 0.5/ug/kg/hr
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.0 years
n=99 Participants
|
74.0 years
n=107 Participants
|
74.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
190 Participants
n=206 Participants
|
|
Education
|
16.0 years
n=99 Participants
|
15.0 years
n=107 Participants
|
16.0 years
n=206 Participants
|
|
Body Mass Index (BMI)
|
28.1 kg/m^2
n=99 Participants
|
27.7 kg/m^2
n=107 Participants
|
28.0 kg/m^2
n=206 Participants
|
|
Anesthesia Time
|
252.0 minutes
n=99 Participants
|
254.0 minutes
n=107 Participants
|
253.0 minutes
n=206 Participants
|
|
Surgical Time
|
174.0 minutes
n=99 Participants
|
180.0 minutes
n=107 Participants
|
177.0 minutes
n=206 Participants
|
|
Mild Cognitive Impairment (MCI)
|
124 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
ASA Status
1 or 2
|
73 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
ASA Status
3
|
108 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
241 Participants
n=206 Participants
|
|
ASA Status
4
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Coronary Artery Disease (CAD)
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Hypertension (HTN)
|
124 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
240 Participants
n=206 Participants
|
|
Congestive Heart Failure (CHF)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Diabetes (DM)
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Cancer (CA)
|
81 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Surgical Procedure
Spine
|
70 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Surgical Procedure
Thoracic
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Surgical Procedure
Orthopedic
|
54 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Surgical Procedure
Urologic
|
20 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Surgical Procedure
General
|
40 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Dosage of Fentanyl used prior to this study
|
250.0 µg/h
n=99 Participants
|
250.0 µg/h
n=107 Participants
|
250.0 µg/h
n=206 Participants
|
|
Propofol
|
170.0 mg/kg
n=99 Participants
|
160.0 mg/kg
n=107 Participants
|
165.0 mg/kg
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)
Outcome measures
| Measure |
Precedex
n=189 Participants
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 Participants
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Delirium Battery
Postoperative Delirium
|
23 Participants
|
23 Participants
|
|
Delirium Battery
PACU Delirium
|
6 Participants
|
8 Participants
|
|
Delirium Battery
Both
|
5 Participants
|
4 Participants
|
|
Delirium Battery
None
|
155 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: at 3 months postoperativelyRate of change of cognitive function - data not collected because secondary analysis which was not performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 1Number of participants with intraoperative bradycardia
Outcome measures
| Measure |
Precedex
n=189 Participants
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 Participants
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Intraoperative Bradycardia
Requiring treatment
|
35 Participants
|
20 Participants
|
|
Intraoperative Bradycardia
Requiring interruption of the drug
|
2 Participants
|
2 Participants
|
|
Intraoperative Bradycardia
Resolved spontaneously
|
45 Participants
|
42 Participants
|
|
Intraoperative Bradycardia
Did not occur
|
107 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: day 1Number of participants with intraoperative hypotension
Outcome measures
| Measure |
Precedex
n=189 Participants
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 Participants
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Intraoperative Hypotension
Requiring Treatment
|
81 Participants
|
69 Participants
|
|
Intraoperative Hypotension
Requiring interruption of the drug
|
3 Participants
|
5 Participants
|
|
Intraoperative Hypotension
Resolved Spontaneously
|
18 Participants
|
21 Participants
|
|
Intraoperative Hypotension
Did not occur
|
87 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: day 1Number of participants with intraoperative hypertension
Outcome measures
| Measure |
Precedex
n=189 Participants
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 Participants
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Intraoperative Hypertension
Requiring treatment
|
26 Participants
|
36 Participants
|
|
Intraoperative Hypertension
Requiring interruption of the drug
|
0 Participants
|
1 Participants
|
|
Intraoperative Hypertension
Resolved spontaneoulsy
|
17 Participants
|
30 Participants
|
|
Intraoperative Hypertension
Did not occur
|
146 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: average 4 daysLength of Stay (LOS) in the hospital
Outcome measures
| Measure |
Precedex
n=189 Participants
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 Participants
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Length of Stay
|
4.0 days
Interval 3.0 to 6.0
|
4.0 days
Interval 3.0 to 6.0
|
Adverse Events
Precedex
Serious events: 12 serious events
Other events: 0 other events
Deaths: 1 deaths
Placebo
Serious events: 9 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Precedex
n=189 participants at risk
Precedex (Dexmedetomidine) 0.5/ug/kg/hr
|
Placebo
n=201 participants at risk
Placebo - normal saline 0.5/ug/kg/hr
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.53%
1/189
|
0.00%
0/201
|
|
Cardiac disorders
Unstable Angina
|
0.53%
1/189
|
0.00%
0/201
|
|
Cardiac disorders
New Arrhythmia
|
1.1%
2/189
|
2.0%
4/201
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.53%
1/189
|
0.00%
0/201
|
|
Cardiac disorders
Heart Failure
|
0.53%
1/189
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.1%
2/189
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Penumonia
|
1.6%
3/189
|
0.50%
1/201
|
|
Vascular disorders
Stroke
|
0.00%
0/189
|
0.50%
1/201
|
|
Vascular disorders
Venous Thrombosis
|
1.1%
2/189
|
1.00%
2/201
|
|
Vascular disorders
Pulmonary Embolus
|
0.53%
1/189
|
0.50%
1/201
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/189
|
0.00%
0/201
|
|
Gastrointestinal disorders
GI Bleed
|
0.53%
1/189
|
0.50%
1/201
|
|
Infections and infestations
Other Infection
|
5.3%
10/189
|
1.00%
2/201
|
|
General disorders
Death
|
0.00%
0/189
|
0.50%
1/201
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stacie Deiner
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7749
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place