Shaping Anesthetic Techniques to Reduce Post-operative Delirium

Study Overview
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Brief Summary
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The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.

Detailed Description
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Post-operative delirium is a common occurrence in older adults. Post -operative delirium has been associated with cognitive decline after hospitalization. Developing perioperative management strategies to prevent delirium may also reduce potential cognitive decline in older adults after surgery. The choice and dose of anesthetic and sedative drugs are known risk factors in the development of delirium. Excessive doses of anesthetic and sedation drugs during surgery have been associated with poor outcomes that occur after surgery. Currently depth of anesthesia can be measured by an additional monitoring technique called Bispectral Index (BIS). The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults. Previous studies have shown that using light sedation and spinal anesthesia during surgery may reduce the incidence of delirium up to 50%.

Official Title
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Shaping Anesthetic Techniques to Reduce Post-Operative Delirium

Conditions
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Delirium, Lumbar Radiculopathy, Lumbar Osteoarthritis, Lumbar Spine Disc Degeneration

Intervention / Treatment
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* Procedure: Light sedation with propofol
* Procedure: Induction with propofol
* Procedure: Maintenance anesthetic using a volatile anesthetic
* Procedure: Muscle relaxant during maintenance anesthesia
* Procedure: Pain control with fentanyl
* Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia
* Procedure: Spinal Anesthesia
* Procedure: Midazolam administered during spinal anesthesia
* Procedure: Cerebrospinal fluid collection
* Procedure: Administration of intrathecal morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients age 65 and over. Patients undergoing lumbar fusion performed by Dr. Charles Edwards II, Dr. Charles Edwards, Dr. Clayton Dean , or Dr. Justin Park at Mercy Medical Center. Expected length of surgery <3 hours. Ability to understand study procedures and to comply with them for the entire length of the study Exclusion Criteria: Contradictions to spinal anesthesia (severe aortic stenosis, anti-coagulant or antiplatelet medications, other) Body mass index > 40 kg/m2 prior lumbar fusion from L2-L5 in entirety Communication issues precluding delirium assessment or sedation Dementia or mini-mental status exam score < 24 Psychiatric disease that would preclude cooperation with sedation with spinal anesthesia Any other reason that the attending anesthesiologist or surgeon feels that clinical circumstances dictate a strong preference for either spinal or general anesthesia. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia<br>In this group patients will receive general anesthesia. Anesthetic induction will occur with propofol (generally 1-2 mg/kg), maintenance with a volatile anesthetic, muscle paralysis with a muscle relaxant, and pain control with fentanyl (generally 2-5 mcg/kg titrated). Patients on baseline opioids may receive additional opioids (such as dilaudid) based on clinical criteria. The anesthetic provider will be blinded to BIS values. Discretionary use of intrathecal morphine may be used. | Procedure: Induction with propofol<br>* Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.<br>Procedure: Maintenance anesthetic using a volatile anesthetic<br>* Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.<br>Procedure: Muscle relaxant during maintenance anesthesia<br>* Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.<br>Procedure: Pain control with fentanyl<br>* Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.<br>Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia<br>* All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.<br>Procedure: Cerebrospinal fluid collection<br>* 8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.<br>Procedure: Administration of intrathecal morphine<br>* Patient may receive intrathecal morphine for post-operative pain control.<br>|
| Experimental: Spinal anesthesia with light sedation<br>In this group patients will receive light sedation with propofol and a spinal anesthetic. Spinal anesthesia will be obtained by injecting approximately 10-15 mg of bupivacaine into the subarachnoid space. Up to 2 mg of midazolam may be given during spinal needle insertion. Although spinal anesthesia is sufficient for surgery, sedation is routinely administered using a propofol infusion, titrated to a BIS>60-70. Discretionary use of intrathecal morphine may be used. | Procedure: Light sedation with propofol<br>* Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.<br>Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia<br>* All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.<br>Procedure: Spinal Anesthesia<br>* Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.<br>Procedure: Midazolam administered during spinal anesthesia<br>* Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.<br>Procedure: Cerebrospinal fluid collection<br>* 8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.<br>Procedure: Administration of intrathecal morphine<br>* Patient may receive intrathecal morphine for post-operative pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days. | First 3 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of cognitive status at 3 months using the Verbal Fluency Test | The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline. | 3 months after surgery | 
| Assessment of cognitive status at 1 year using the Verbal Fluency test. | The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline. | 1 year after surgery | 
| Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test. | At 3 months, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score. | 3 months after surgery | 
| Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test. | At 1 year, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score. | 1 year after surgery | 
| Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12) | This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. | 3 months after surgery | 
| Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12) | This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. | 1 year after surgery | 
| Assessment of functional status at 3 months using the Oswestry Disability Index (ODI) | This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the baseline score. | 3 months after surgery | 
| Assessment of functional status at 1 year using the Oswestry Disability Index (ODI) | This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the scores obtained at baseline and 3 months after surgery. | 1 year after surgery | 
| Assessment of cognitive status at 3 months using Trail Making Test | This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the score obtained at baseline. | 3 months after surgery | 
| Assessment of cognitive status at 1 year using Trail Making Test | This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the scores obtained at baseline and 1 year after surgery. | 1 year after surgery | 
| Assessment of cognitive status at 3 months using the Digit Span | The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the score obtained at baseline. | 3 months after surgery | 
| Assessment of cognitive status at 1 year using the Digit Span | The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the scores obtained at baseline and 3 months after surgery. | 1 year after surgery | 
| Assessment of the cognitive status at 3 months using the Mini Mental Status Exam | The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. This score will be compared to the score obtained at baseline. | 3 months after surgery | 
| Assessment of the cognitive status at 1 year using the Mini Mental Status Exam | The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. The score obtained will be compared to the scores obtained at baseline and 3 months after surgery. | 1 year after surgery | 
| Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS) | The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment. | 3 months after surgery | 
| Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS) | The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment. | 1 year after surgery | 
| Maximum severity of delirium during hospital stay | The patient will be assessed for delirium using the maximum total score on the Delirium Rating Scale-Revised 1998. The scale range is 0-32, with 0 being low delirium severity and 32 being high delirium severity. | Through the end of hospitalization, up to 3 months | 
| Number of participants with hospital readmissions within 30 days of discharge | Hospital readmissions will be measured. | 30 days from hospital discharge | 
| Number of participants with emergency room visit within 30 days of hospital discharge | Emergency Room Visits will be measured. | 30 days from hospital discharge | 
| Number of days in hospital after surgery | The number of days in hospital after surgery will be calculated for each patient. | Immediately after surgery until discharge, up to 3 months | 
| Last pain score in the post-anesthesia care unit | The last pain score on the NRS pain scale of 0-10 taken in the post-anesthesia care unit by the post-anesthesia care unit staff. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | Immediately before leaving the post-anesthesia care unit, up to 1 day | 
| Total morphine equivalents of opioids given in the post-anesthesia care unit | The total amount of opioids given to each patient in the post-anesthesia care unit will be converted to morphine equivalents for each patient. | During post-anesthesia care unit stay, up to 1 week | 
| Time first opioid given in the post-anesthesia care unit | The time will be noted when the first opioid is given to each participant in the post-anesthesia care unit. | The time the first opioid medication is given to the patient in the post-anesthesia care unit, up to 1 week | 
| Last pain score prior to hospital discharge | The last pain score recorded for each participant on the NRS pain scale of 0-10. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | Immediately before hospital discharge | 
| Total amount of morphine equivalents during hospital stay | The total amount of morphine equivalents will be measure for each participants hospital stay. The amount measured will be pro-rated tp the participant's length of stay. | Duration of the hospital length of stay, up to 3 months | 
| The average pain score at 3 month follow-up | The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 3 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | one week prior to end of 3 month follow-up | 
| The average pain score at 12 month follow-up | The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 12 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | one week prior to end of 12 month follow-up | 
| Number of days with delirium | The number of days with delirium will measured for each participant during the length of the hospital stay for each participant. | Duration of the hospital stay, up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium, elderly, lumbar, surgery