Delirium, Hip Fractures
Conditions
Keywords
Hip fractures, Femoral neck fractures, Trochanteric fractures, Intertrochanteric fractures, Subtrochanteric fractures, Delirium, Confusion
Brief summary
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
Detailed description
We give sedative drugs to patients having spinal anesthesia so they are asleep (sedated) while we are fixing their broken hips. The spinal anesthesia provides pain relief at the site of surgery, while the sedative drugs keep people asleep during the procedure. We want to find out whether the amount of sedation we give might (1) make patients be confused when they wake up or (2) have anything to do with how well patients can do their ordinary daily routines a few months after their surgery.
Interventions
DEVICEDeeper sedation
The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
DEVICEModerate sedation
The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* is 65 years of age or older at admission; * has surgical treatment of a traumatic hip fracture; * has participating surgeon; * has Mini-Mental Status Exam score of 15 or higher; * able to read/write/speak/hear/understand English; * gives informed consent; * receives spinal anesthesia
Exclusion criteria
* receives general anesthesia; * does not write/write/speak/hear/understand English; * has severe chronic obstructive pulmonary disease (COPD); * has severe congestive heart failure (CHF); * has Mini-Mental Status Exam score less than 15; * declines to give informed consent; * age less than 65 years at admission; * attending surgeon does not participate in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method | Postoperative days up to hospital discharge | The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Status | 12 months post-operative | Ability to perform Activities of Daily Living (ADL) using 6-point Katz activities of daily living scale, assessed at 12 months post-op. The range of the Katz activities of daily living scale is from 0-6, 0 is worse and 6 is best. |
| Mortality | 12 months post-operative | death occurring during follow-up period, in one year post-op. |
| Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method | 1 month (30 days) post-intervention | The presence of delirium is assessed by the confusion assessment method (CAM), after 1 month postoperative. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4. |
| Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score | 12 months post-operative | Clinical Dementia Rating consists of 6 domains (boxes) of function: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain (box) is rated on a 5-point scale (0= no impairment, 0.5=questionable impairment, 1= mild impairment, 2= moderated impairment, 3= severe impairment. The CDR-SOB score is a sum of these ratings, for a total Sum of boxes ranging from 0-18, where 0=cognitively intact. Increasing sum of boxes score is associated with greater cognitive impairment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deeper Sedation Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the deeper sedation arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0. | 100 |
| Moderate Sedation Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the moderate sedation arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Deeper Sedation | Moderate Sedation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 100 Participants | 100 Participants | 200 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 82 years STANDARD_DEVIATION 7 | 82 years STANDARD_DEVIATION 8 | 82 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 97 Participants | 97 Participants | 194 Participants |
| Sex: Female, Male Female | 74 Participants | 72 Participants | 146 Participants |
| Sex: Female, Male Male | 26 Participants | 28 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 100 | 14 / 100 |
| other Total, other adverse events | 69 / 100 | 69 / 100 |
| serious Total, serious adverse events | 15 / 100 | 14 / 100 |
Outcome results
Primary
Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Time frame: Postoperative days up to hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deeper Sedation | Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method | 39 Participants |
| Moderate Sedation | Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method | 34 Participants |
Secondary
Change in Functional Status
Ability to perform Activities of Daily Living (ADL) using 6-point Katz activities of daily living scale, assessed at 12 months post-op. The range of the Katz activities of daily living scale is from 0-6, 0 is worse and 6 is best.
Time frame: 12 months post-operative
Population: ADL score at 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deeper Sedation | Change in Functional Status | 4.2 units on a scale | Standard Deviation 1.5 |
| Moderate Sedation | Change in Functional Status | 4.1 units on a scale | Standard Deviation 1.6 |
Secondary
Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score
Clinical Dementia Rating consists of 6 domains (boxes) of function: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain (box) is rated on a 5-point scale (0= no impairment, 0.5=questionable impairment, 1= mild impairment, 2= moderated impairment, 3= severe impairment. The CDR-SOB score is a sum of these ratings, for a total Sum of boxes ranging from 0-18, where 0=cognitively intact. Increasing sum of boxes score is associated with greater cognitive impairment.
Time frame: 12 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deeper Sedation | Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score | 2.0 units on a scale | Standard Deviation 3 |
| Moderate Sedation | Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score | 2.0 units on a scale | Standard Deviation 3 |
Secondary
Mortality
death occurring during follow-up period, in one year post-op.
Time frame: 12 months post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deeper Sedation | Mortality | 14 Participants |
| Moderate Sedation | Mortality | 14 Participants |
Secondary
Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method
The presence of delirium is assessed by the confusion assessment method (CAM), after 1 month postoperative. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Time frame: 1 month (30 days) post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deeper Sedation | Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method | 3 Participants |
| Moderate Sedation | Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method | 1 Participants |