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Shaping Anesthetic Techniques to Reduce Post-operative Delirium (SHARP)

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ClinicalTrials.gov Identifier: NCT03133845
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
Mercy Medical Center
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delirium Lumbar Radiculopathy Lumbar Osteoarthritis Lumbar Spine Disc Degeneration 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 Not Applicable

Detailed Description:

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%.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shaping Anesthetic Techniques to Reduce Post-Operative Delirium
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: General anesthesia
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
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.

Procedure: Maintenance anesthetic using a volatile anesthetic
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.

Procedure: Muscle relaxant during maintenance anesthesia
Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.

Procedure: Pain control with fentanyl
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.

Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia
All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.

Procedure: Cerebrospinal fluid collection
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.

Procedure: Administration of intrathecal morphine
Patient may receive intrathecal morphine for post-operative pain control.

Experimental: Spinal anesthesia with light sedation
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
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.

Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia
All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.

Procedure: Spinal Anesthesia
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.

Procedure: Midazolam administered during spinal anesthesia
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.

Procedure: Cerebrospinal fluid collection
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.

Procedure: Administration of intrathecal morphine
Patient may receive intrathecal morphine for post-operative pain control.




Primary Outcome Measures :
  1. Incidence of delirium [ Time Frame: First 3 postoperative days ]
    The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days.


Secondary Outcome Measures :
  1. Assessment of cognitive status at 3 months using the Verbal Fluency Test [ Time Frame: 3 months after surgery ]
    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.

  2. Assessment of cognitive status at 1 year using the Verbal Fluency test. [ Time Frame: 1 year after surgery ]
    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. Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test. [ Time Frame: 3 months after surgery ]
    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.

  4. Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test. [ Time Frame: 1 year after surgery ]
    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.

  5. Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12) [ Time Frame: 3 months after surgery ]
    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.

  6. Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12) [ Time Frame: 1 year after surgery ]
    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.

  7. Assessment of functional status at 3 months using the Oswestry Disability Index (ODI) [ Time Frame: 3 months after surgery ]
    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.

  8. Assessment of functional status at 1 year using the Oswestry Disability Index (ODI) [ Time Frame: 1 year after surgery ]
    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.

  9. Assessment of cognitive status at 3 months using Trail Making Test [ Time Frame: 3 months after surgery ]
    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.

  10. Assessment of cognitive status at 1 year using Trail Making Test [ Time Frame: 1 year after surgery ]
    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.

  11. Assessment of cognitive status at 3 months using the Digit Span [ Time Frame: 3 months after surgery ]
    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.

  12. Assessment of cognitive status at 1 year using the Digit Span [ Time Frame: 1 year after surgery ]
    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.

  13. Assessment of the cognitive status at 3 months using the Mini Mental Status Exam [ Time Frame: 3 months after surgery ]
    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.

  14. Assessment of the cognitive status at 1 year using the Mini Mental Status Exam [ Time Frame: 1 year after surgery ]
    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.

  15. Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS) [ Time Frame: 3 months after surgery ]
    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.

  16. Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS) [ Time Frame: 1 year after surgery ]
    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.

  17. Maximum severity of delirium during hospital stay [ Time Frame: Through the end of hospitalization, up to 3 months ]
    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.

  18. Number of participants with hospital readmissions within 30 days of discharge [ Time Frame: 30 days from hospital discharge ]
    Hospital readmissions will be measured.

  19. Number of participants with emergency room visit within 30 days of hospital discharge [ Time Frame: 30 days from hospital discharge ]
    Emergency Room Visits will be measured.

  20. Number of days in hospital after surgery [ Time Frame: Immediately after surgery until discharge, up to 3 months ]
    The number of days in hospital after surgery will be calculated for each patient.

  21. Last pain score in the post-anesthesia care unit [ Time Frame: Immediately before leaving the post-anesthesia care unit, up to 1 day ]
    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.

  22. Total morphine equivalents of opioids given in the post-anesthesia care unit [ Time Frame: During post-anesthesia care unit stay, up to 1 week ]
    The total amount of opioids given to each patient in the post-anesthesia care unit will be converted to morphine equivalents for each patient.

  23. Time first opioid given 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 ]
    The time will be noted when the first opioid is given to each participant in the post-anesthesia care unit.

  24. Last pain score prior to hospital discharge [ Time Frame: Immediately before 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.

  25. Total amount of morphine equivalents during hospital stay [ Time Frame: Duration of the hospital length of stay, up to 3 months ]
    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.

  26. The average pain score at 3 month follow-up [ Time Frame: one week prior to end of 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.

  27. The average pain score at 12 month follow-up [ Time Frame: one week prior to end of 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.

  28. Number of days with delirium [ Time Frame: Duration of the hospital stay, up to 3 months ]
    The number of days with delirium will measured for each participant during the length of the hospital stay for each participant.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133845


Locations
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United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
Mercy Medical Center
Investigators
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Principal Investigator: Charles C Edwards, MD Mercy Hospital of Baltimore
Principal Investigator: Charles Brown, MD Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03133845     History of Changes
Other Study ID Numbers: IRB00113655
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
delirium
elderly
lumbar
surgery
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Osteoarthritis, Spine
Delirium
Radiculopathy
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Peripheral Nervous System Diseases
Neuromuscular Diseases
Spinal Diseases
Bone Diseases
Spondylarthritis
Spondylitis
Fentanyl
Midazolam
Morphine
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives