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

Primary Purpose

Delirium, Lumbar Radiculopathy, Lumbar Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light sedation with propofol
Induction with propofol
Maintenance anesthetic using a volatile anesthetic
Muscle relaxant during maintenance anesthesia
Pain control with fentanyl
Bispectral Index (BIS) monitoring for depth of anesthesia
Spinal Anesthesia
Midazolam administered during spinal anesthesia
Cerebrospinal fluid collection
Administration of intrathecal morphine
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring delirium, elderly, lumbar, surgery

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mercy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

General anesthesia

Spinal anesthesia with light sedation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of delirium
The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of participants with hospital readmissions within 30 days of discharge
Hospital readmissions will be measured.
Number of participants with emergency room visit within 30 days of hospital discharge
Emergency Room Visits will be measured.
Number of days in hospital after surgery
The number of days in hospital after surgery will be calculated for each patient.
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.
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 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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 23, 2015
Last Updated
June 17, 2020
Sponsor
Johns Hopkins University
Collaborators
Mercy Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03133845
Brief Title
Shaping Anesthetic Techniques to Reduce Post-operative Delirium
Acronym
SHARP
Official Title
Shaping Anesthetic Techniques to Reduce Post-Operative Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
May 25, 2020 (Actual)
Study Completion Date
May 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Mercy Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Lumbar Radiculopathy, Lumbar Osteoarthritis, Lumbar Spine Disc Degeneration
Keywords
delirium, elderly, lumbar, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Spinal anesthesia with light sedation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Light sedation with propofol
Intervention Description
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
Intervention Type
Procedure
Intervention Name(s)
Induction with propofol
Intervention Description
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
Intervention Type
Procedure
Intervention Name(s)
Maintenance anesthetic using a volatile anesthetic
Intervention Description
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Muscle relaxant during maintenance anesthesia
Intervention Description
Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
Intervention Type
Procedure
Intervention Name(s)
Pain control with fentanyl
Intervention Description
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
Intervention Type
Procedure
Intervention Name(s)
Bispectral Index (BIS) monitoring for depth of anesthesia
Intervention Description
All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
Intervention Type
Procedure
Intervention Name(s)
Midazolam administered during spinal anesthesia
Intervention Description
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Cerebrospinal fluid collection
Intervention Description
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
Intervention Type
Procedure
Intervention Name(s)
Administration of intrathecal morphine
Intervention Description
Patient may receive intrathecal morphine for post-operative pain control.
Primary Outcome Measure Information:
Title
Incidence of delirium
Description
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
Secondary Outcome Measure Information:
Title
Assessment of cognitive status at 3 months using the Verbal Fluency Test
Description
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
Title
Assessment of cognitive status at 1 year using the Verbal Fluency test.
Description
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
Title
Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.
Description
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
Title
Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.
Description
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
Title
Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)
Description
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
Title
Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)
Description
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
Title
Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)
Description
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
Title
Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)
Description
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
Title
Assessment of cognitive status at 3 months using Trail Making Test
Description
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
Title
Assessment of cognitive status at 1 year using Trail Making Test
Description
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
Title
Assessment of cognitive status at 3 months using the Digit Span
Description
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
Title
Assessment of cognitive status at 1 year using the Digit Span
Description
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
Title
Assessment of the cognitive status at 3 months using the Mini Mental Status Exam
Description
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
Title
Assessment of the cognitive status at 1 year using the Mini Mental Status Exam
Description
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
Title
Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)
Description
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
Title
Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)
Description
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
Title
Maximum severity of delirium during hospital stay
Description
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
Title
Number of participants with hospital readmissions within 30 days of discharge
Description
Hospital readmissions will be measured.
Time Frame
30 days from hospital discharge
Title
Number of participants with emergency room visit within 30 days of hospital discharge
Description
Emergency Room Visits will be measured.
Time Frame
30 days from hospital discharge
Title
Number of days in hospital after surgery
Description
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
Title
Last pain score in the post-anesthesia care unit
Description
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
Title
Total morphine equivalents of opioids given in the post-anesthesia care unit
Description
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
Title
Time first opioid given in the post-anesthesia care unit
Description
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
Title
Last pain score prior to hospital discharge
Description
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
Title
Total amount of morphine equivalents during hospital stay
Description
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
Title
The average pain score at 3 month follow-up
Description
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
Title
The average pain score at 12 month follow-up
Description
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
Title
Number of days with delirium
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles C Edwards, MD
Organizational Affiliation
Mercy Hospital of Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31656179
Citation
Brown CH 4th, Jones EL, Lin C, Esmaili M, Gorashi Y, Skelton RA, Kaganov D, Colantuoni EA, Yanek LR, Neufeld KJ, Kamath V, Sieber FE, Dean CL, Edwards CC 2nd, Hogue CW. Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery. BMC Anesthesiol. 2019 Oct 27;19(1):192. doi: 10.1186/s12871-019-0867-7.
Results Reference
derived

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Shaping Anesthetic Techniques to Reduce Post-operative Delirium

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