Shaping Anesthetic Techniques to Reduce Post-operative Delirium
NCT ID: NCT03133845
Last Updated: 2020-06-18
Study Results
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Basic Information
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COMPLETED
NA
218 participants
INTERVENTIONAL
2015-10-31
2020-05-25
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Induction with propofol
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
Maintenance anesthetic using a volatile anesthetic
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
Muscle relaxant during maintenance anesthesia
Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
Pain control with fentanyl
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
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.
Cerebrospinal fluid collection
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
Administration of intrathecal morphine
Patient may receive intrathecal morphine for post-operative pain control.
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.
Light sedation with propofol
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
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.
Spinal Anesthesia
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
Midazolam administered during spinal anesthesia
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
Cerebrospinal fluid collection
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
Administration of intrathecal morphine
Patient may receive intrathecal morphine for post-operative pain control.
Interventions
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Light sedation with propofol
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
Induction with propofol
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
Maintenance anesthetic using a volatile anesthetic
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
Muscle relaxant during maintenance anesthesia
Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
Pain control with fentanyl
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
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.
Spinal Anesthesia
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
Midazolam administered during spinal anesthesia
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
Cerebrospinal fluid collection
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
Administration of intrathecal morphine
Patient may receive intrathecal morphine for post-operative pain control.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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Mercy Medical Center
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Charles C Edwards, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy Hospital of Baltimore
Charles Brown, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Mercy Medical Center
Baltimore, Maryland, United States
Countries
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References
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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.
Other Identifiers
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IRB00113655
Identifier Type: -
Identifier Source: org_study_id
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