Trial Outcomes & Findings for Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (NCT NCT00586196)
NCT ID: NCT00586196
Last Updated: 2014-08-22
Results Overview
Confusion Assessment Method (CAM)-Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline, hospital interviews, weeks 2, 4 and 6
Results posted on
2014-08-22
Participant Flow
Participant milestones
| Measure |
Donepezil : 5 mg Each Day for 30 Days
donepezil : 5 mg each day for 30 days
|
Placebo : Encapsulated Cornstarch
Placebo : Encapsulated cornstarch One capsule daily for 30 days
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Baseline characteristics by cohort
| Measure |
Donepezil : 5 mg Each Day for 30 Days
n=7 Participants
donepezil : 5 mg each day for 30 days
|
Placebo : Encapsulated Cornstarch
n=9 Participants
Placebo : Encapsulated cornstarch One capsule daily for 30 days
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
88 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
87 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
87 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, hospital interviews, weeks 2, 4 and 6Confusion Assessment Method (CAM)-Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.
Outcome measures
| Measure |
Donepezil : 5 mg Each Day for 30 Days
n=7 Participants
donepezil : 5 mg each day for 30 days
|
Placebo : Encapsulated Cornstarch
n=9 Participants
Placebo : Encapsulated cornstarch One capsule daily for 30 days
|
|---|---|---|
|
Percentage of Participants With Delirium Using the CAM Over Time
basline
|
14 percentage of participants
|
44 percentage of participants
|
|
Percentage of Participants With Delirium Using the CAM Over Time
hospital interviews
|
64 percentage of participants
|
64 percentage of participants
|
|
Percentage of Participants With Delirium Using the CAM Over Time
Week 2
|
43 percentage of participants
|
43 percentage of participants
|
|
Percentage of Participants With Delirium Using the CAM Over Time
week 4
|
17 percentage of participants
|
43 percentage of participants
|
|
Percentage of Participants With Delirium Using the CAM Over Time
week 6
|
50 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, hospital discharge, weeks 2, 4 and 6Population: Based on ability to recruit
Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.
Outcome measures
| Measure |
Donepezil : 5 mg Each Day for 30 Days
n=7 Participants
donepezil : 5 mg each day for 30 days
|
Placebo : Encapsulated Cornstarch
n=9 Participants
Placebo : Encapsulated cornstarch One capsule daily for 30 days
|
|---|---|---|
|
Change From Baseline and MDAS Scores Over Time
Baseline
|
6.3 units on a scale
Standard Deviation 3.4
|
8.4 units on a scale
Standard Deviation 6.5
|
|
Change From Baseline and MDAS Scores Over Time
Change at Hospital Discharge
|
1.3 units on a scale
Standard Deviation 2.5
|
1.6 units on a scale
Standard Deviation 5.2
|
|
Change From Baseline and MDAS Scores Over Time
Change at Week 2
|
-0.1 units on a scale
Standard Deviation 2.3
|
-2.2 units on a scale
Standard Deviation 4.9
|
|
Change From Baseline and MDAS Scores Over Time
Change at week 4
|
-1.2 units on a scale
Standard Deviation 3.5
|
-2.0 units on a scale
Standard Deviation 6.4
|
|
Change From Baseline and MDAS Scores Over Time
Change at week 6
|
-0.6 units on a scale
Standard Deviation 2.6
|
-2.0 units on a scale
Standard Deviation 7.5
|
Adverse Events
Donepezil : 5 mg Each Day for 30 Days
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo : Encapsulated Cornstarch
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donepezil : 5 mg Each Day for 30 Days
n=7 participants at risk
donepezil : 5 mg each day for 30 days
|
Placebo : Encapsulated Cornstarch
n=9 participants at risk
Placebo : Encapsulated cornstarch One capsule daily for 30 days
|
|---|---|---|
|
General disorders
Serious Adverse Event
|
28.6%
2/7 • Number of events 2
|
0.00%
0/9
|
Other adverse events
| Measure |
Donepezil : 5 mg Each Day for 30 Days
n=7 participants at risk
donepezil : 5 mg each day for 30 days
|
Placebo : Encapsulated Cornstarch
n=9 participants at risk
Placebo : Encapsulated cornstarch One capsule daily for 30 days
|
|---|---|---|
|
Nervous system disorders
Insomnia
|
71.4%
5/7
|
11.1%
1/9
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7
|
22.2%
2/9
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7
|
11.1%
1/9
|
|
Nervous system disorders
Syncope
|
14.3%
1/7
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
11.1%
1/9
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/7
|
11.1%
1/9
|
|
Renal and urinary disorders
Frequency of Urination
|
14.3%
1/7
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place