DeliriumSHARPNCT03133845
Shaping Anesthetic Techniques to Reduce Post-operative Delirium
A study testing Light sedation with propofol, Induction with propofol and Maintenance anesthetic using a volatile anesthetic in people with Delirium and Lumbar Radiculopathy, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Lumbar Radiculopathy, Lumbar Osteoarthritis
- What is being tested?
- Light sedation with propofol, Induction with propofol and Maintenance anesthetic using a volatile anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 25 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shaping Anesthetic Techniques to Reduce Post-Operative Delirium
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.
Read the 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%.
- Being tested
- Light sedation with propofol, Induction with propofol, Maintenance anesthetic using a volatile anesthetic, Muscle relaxant during maintenance anesthesia, Pain control with fentanyl
- Keywords
- delirium, elderly, lumbar, surgery
- Medical subject headings
- Delirium, Radiculopathy, Osteoarthritis, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light sedation with propofolProcedure or surgery
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
Induction with propofolProcedure or surgery
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
Maintenance anesthetic using a volatile anestheticProcedure or surgery
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
Muscle relaxant during maintenance anesthesiaProcedure or surgery
Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
Pain control with fentanylProcedure or surgery
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
Bispectral Index (BIS) monitoring for depth of anesthesiaProcedure or surgery
All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.
Spinal AnesthesiaProcedure or surgery
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
Midazolam administered during spinal anesthesiaProcedure or surgery
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
Cerebrospinal fluid collectionProcedure or surgery
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
Administration of intrathecal morphineProcedure or surgery
Patient may receive intrathecal morphine for post-operative pain control.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | 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. Receives: 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: Cerebrospinal fluid collection; Procedure: Administration of intrathecal morphine |
| Spinal anesthesia with light sedation | Experimental | 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. Receives: Procedure: Light sedation with propofol; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days.
Measured: First 3 postoperative days
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of the hospital stay, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startOct 2015
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Medical Center
- Responsible party
- Sponsor
- Investigators
- Charles C Edwards, MD, Principal investigator, Mercy Hospital of BaltimoreCharles Brown, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133845
- Sponsor's protocol ID
- IRB00113655
- Acronym
- SHARP
- Status last verified
- Jun 2020
- First submitted
- 23 Oct 2015
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31656179
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shaping Anesthetic Techniques to Reduce Post-Operative Delirium
- ClinicalTrials.gov ID
- NCT03133845
- Acronym / sponsor ID
- SHARP / IRB00113655
- Keywords
- delirium, elderly, lumbar, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Mercy Medical Center
- Study start
- Oct 2015 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | 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: Cerebrospinal fluid collection, Procedure: Administration of intrathecal morphineIn 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. |
| Spinal anesthesia with light sedation | Experimental | Procedure: Light sedation with propofol, 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 morphineIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light sedation with propofolPatients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation. | Procedure or surgery | Spinal anesthesia with light sedation |
| Induction with propofolPatients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent. | Procedure or surgery | General anesthesia |
| Maintenance anesthetic using a volatile anestheticPatients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia. | Procedure or surgery | General anesthesia |
| Muscle relaxant during maintenance anesthesiaPatients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis. | Procedure or surgery | General anesthesia |
| Pain control with fentanylPatients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery. | Procedure or surgery | General anesthesia |
| Bispectral Index (BIS) monitoring for depth of anesthesiaAll patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia. | Procedure or surgery | General anesthesia, Spinal anesthesia with light sedation |
| Spinal AnesthesiaPatients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space. | Procedure or surgery | Spinal anesthesia with light sedation |
| Midazolam administered during spinal anesthesiaMidazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia. | Procedure or surgery | Spinal anesthesia with light sedation |
| Cerebrospinal fluid collection8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control. | Procedure or surgery | General anesthesia, Spinal anesthesia with light sedation |
| Administration of intrathecal morphinePatient may receive intrathecal morphine for post-operative pain control. | Procedure or surgery | General anesthesia, Spinal anesthesia with light sedation |
Primary outcome
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.
28 secondary outcomes
Assessment of cognitive status at 3 months using the Verbal Fluency Test
Time frame: 3 months after surgery
Assessment of cognitive status at 1 year using the Verbal Fluency test.
Time frame: 1 year after surgery
Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.
Time frame: 3 months after surgery
Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.
Time frame: 1 year after surgery
Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)
Time frame: 3 months after surgery
Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)
Time frame: 1 year after surgery
Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)
Time frame: 3 months after surgery
Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)
Time frame: 1 year after surgery
Assessment of cognitive status at 3 months using Trail Making Test
Time frame: 3 months after surgery
Assessment of cognitive status at 1 year using Trail Making Test
Time frame: 1 year after surgery
Assessment of cognitive status at 3 months using the Digit Span
Time frame: 3 months after surgery
Assessment of cognitive status at 1 year using the Digit Span
Time frame: 1 year after surgery
Assessment of the cognitive status at 3 months using the Mini Mental Status Exam
Time frame: 3 months after surgery
Assessment of the cognitive status at 1 year using the Mini Mental Status Exam
Time frame: 1 year after surgery
Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)
Time frame: 3 months after surgery
Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)
Time frame: 1 year after surgery
Maximum severity of delirium during hospital stay
Time frame: Through the end of hospitalization, up to 3 months
Number of participants with hospital readmissions within 30 days of discharge
Time frame: 30 days from hospital discharge
Number of participants with emergency room visit within 30 days of hospital discharge
Time frame: 30 days from hospital discharge
Number of days in hospital after surgery
Time frame: Immediately after surgery until discharge, up to 3 months
Last pain score in the post-anesthesia care unit
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
Time frame: During post-anesthesia care unit stay, up to 1 week
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
Last pain score prior to hospital discharge
Time frame: Immediately before hospital discharge
Total amount of morphine equivalents during hospital stay
Time frame: Duration of the hospital length of stay, up to 3 months
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 at 12 month follow-up
Time frame: one week prior to end of 12 month follow-up
Number of days with delirium
Time frame: Duration of the hospital stay, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 31656179Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles C Edwards, MD principal investigator
Mercy Hospital of Baltimore
Charles Brown, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light sedation with propofol, Induction with propofol and Maintenance anesthetic using a volatile anesthetic in people with Delirium and Lumbar Radiculopathy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: First 3 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.