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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Lumbar Radiculopathy; Lumbar Osteoarthritis; Lumbar Spine Disc Degeneration
• Intervention / Treatment: 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; Procedure: Light sedation with propofol; Procedure: Spinal Anesthesia; Procedure: Midazolam administered during spinal anesthesia

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 Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; Procedure: Light sedation with propofol; Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Mercy Medical Center
• Investigators: Principal Investigator: Charles C Edwards, MD, Mercy Hospital of Baltimore

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): May 25, 2020
• Study Completion (ACTUAL): May 25, 2020

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: delirium; surgery; elderly; lumbar
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Spondylarthritis; Spondylitis; Osteoarthritis; Delirium; Intervertebral Disc Degeneration; Radiculopathy; Osteoarthritis, Spine; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics; Fentanyl; Midazolam; Propofol; Morphine
• Other Study ID Numbers: IRB00113655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO