Post-Operative Delirium in Elderly Surgical Patients

Study Overview
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Brief Summary
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This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.

Detailed Description
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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.

Official Title
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A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients

Conditions
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Hip Fractures, Delirium

Intervention / Treatment
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* Device: Deeper sedation
* Device: Moderate sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deeper sedation<br>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. | Device: Deeper sedation<br>* 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.<br>* Other names: Observer's Assessment of Awareness/Sedation Scale (OAA/S);|
| Active Comparator: Moderate sedation<br>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. | Device: Moderate sedation<br>* 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.<br>* Other names: Observer's Assessment of Awareness/Sedation Scale (OAA/S);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative days up to hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months post-operative | 
| Mortality | death occurring during follow-up period, in one year post-op. | 12 months post-operative | 
| 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. | 1 month (30 days) post-intervention | 
| 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. | 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fractures, Femoral neck fractures, Trochanteric fractures, Intertrochanteric fractures, Subtrochanteric fractures, Delirium, Confusion