Shaping Anesthetic Techniques to Reduce Post-operative Delirium

Not Applicable

Completed

• Conditions: Delirium; Lumbar Osteoarthritis; Lumbar Radiculopathy; Lumbar Spine Disc Degeneration
• Interventions: Procedure: Induction with propofol; Procedure: Light sedation with propofol; Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia; Procedure: Maintenance anesthetic using a volatile anesthetic; Procedure: Muscle relaxant during maintenance anesthesia; Procedure: Spinal Anesthesia; Procedure: Midazolam administered during spinal anesthesia; Procedure: Pain control with fentanyl; Procedure: Cerebrospinal fluid collection; Procedure: Administration of intrathecal morphine

• Registration Number: NCT03133845
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	Muscle relaxant during maintenance 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.
Spinal anesthesia with light sedation	Bispectral Index (BIS) monitoring for depth of anesthesia	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.
Spinal anesthesia with light sedation	Administration of intrathecal morphine	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.
General anesthesia	Induction with propofol	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.
General anesthesia	Bispectral Index (BIS) monitoring for depth of 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.
Spinal anesthesia with light sedation	Light sedation with propofol	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.
Spinal anesthesia with light sedation	Cerebrospinal fluid collection	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.
General anesthesia	Cerebrospinal fluid collection	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.
General anesthesia	Administration of intrathecal morphine	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.
Spinal anesthesia with light sedation	Midazolam administered during spinal anesthesia	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.
General anesthesia	Maintenance anesthetic using a volatile anesthetic	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.
General anesthesia	Pain control with fentanyl	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.
Spinal anesthesia with light sedation	Spinal Anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Incidence of delirium	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

Name	Time	Method
Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)	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.
Maximum severity of delirium during hospital stay	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.
Total amount of morphine equivalents during hospital stay	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.
Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.	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.
Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)	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.
Assessment of cognitive status at 3 months using Trail Making Test	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.
Assessment of cognitive status at 3 months using the Digit Span	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.
Assessment of the cognitive status at 1 year using the Mini Mental Status Exam	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.
Number of participants with emergency room visit within 30 days of hospital discharge	30 days from hospital discharge	Emergency Room Visits will be measured.
Time first opioid given 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	The time will be noted when the first opioid is given to each participant in the post-anesthesia care unit.
Assessment of cognitive status at 1 year using the Verbal Fluency test.	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.
Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)	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.
Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)	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.
Assessment of cognitive status at 1 year using Trail Making Test	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.
Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)	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.
Assessment of cognitive status at 3 months using the Verbal Fluency Test	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.
Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.	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.
Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)	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.
Number of participants with hospital readmissions within 30 days of discharge	30 days from hospital discharge	Hospital readmissions will be measured.
The average pain score at 3 month follow-up	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.
Assessment of cognitive status at 1 year using the Digit Span	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.
Assessment of the cognitive status at 3 months using the Mini Mental Status Exam	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.
Number of days in hospital after surgery	Immediately after surgery until discharge, up to 3 months	The number of days in hospital after surgery will be calculated for each patient.
Last pain score in the post-anesthesia care unit	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.
Total morphine equivalents of opioids given in the post-anesthesia care unit	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.
The average pain score at 12 month follow-up	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.
Number of days with delirium	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.
Last pain score prior to hospital discharge	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.

Trial Locations

Locations (1)

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States