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.
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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
218
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
Mercy Medical Center
Baltimore, Maryland, United States
Incidence of delirium
The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days.
Time frame: First 3 postoperative days
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after surgery
Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.
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Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
Patient may receive intrathecal morphine for post-operative pain control.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days from hospital discharge
Number of participants with emergency room visit within 30 days of hospital discharge
Emergency Room Visits will be measured.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of the hospital stay, up to 3 months