Clinical trial NCT03133845: Shaping Anesthetic Techniques to Reduce Post-operative Delirium
Official title: Shaping Anesthetic Techniques to Reduce Post-Operative Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Lumbar Radiculopathy
Lumbar Osteoarthritis
Lumbar Spine Disc Degeneration
Keywords: delirium
elderly
lumbar
surgery
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Mercy Medical Center
First posted: 2017-04-28
Enrollment: 218
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Incidence of delirium
timeFrame: First 3 postoperative days
Secondary outcomes:
measure: Assessment of cognitive status at 3 months using the Verbal Fluency Test
timeFrame: 3 months after surgery
measure: Assessment of cognitive status at 1 year using the Verbal Fluency test.
timeFrame: 1 year after surgery
measure: Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.
timeFrame: 3 months after surgery
measure: Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.
timeFrame: 1 year after surgery
measure: Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)
timeFrame: 3 months after surgery
measure: Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)
timeFrame: 1 year after surgery
measure: Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)
timeFrame: 3 months after surgery
measure: Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)
timeFrame: 1 year after surgery
measure: Assessment of cognitive status at 3 months using Trail Making Test
timeFrame: 3 months after surgery
measure: Assessment of cognitive status at 1 year using Trail Making Test
timeFrame: 1 year after surgery
measure: Assessment of cognitive status at 3 months using the Digit Span
timeFrame: 3 months after surgery
measure: Assessment of cognitive status at 1 year using the Digit Span
timeFrame: 1 year after surgery
measure: Assessment of the cognitive status at 3 months using the Mini Mental Status Exam
timeFrame: 3 months after surgery
measure: Assessment of the cognitive status at 1 year using the Mini Mental Status Exam
timeFrame: 1 year after surgery
measure: Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)
timeFrame: 3 months after surgery
measure: Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)
timeFrame: 1 year after surgery
measure: Maximum severity of delirium during hospital stay
timeFrame: Through the end of hospitalization, up to 3 months
measure: Number of participants with hospital readmissions within 30 days of discharge
timeFrame: 30 days from hospital discharge
measure: Number of participants with emergency room visit within 30 days of hospital discharge
timeFrame: 30 days from hospital discharge
measure: Number of days in hospital after surgery
timeFrame: Immediately after surgery until discharge, up to 3 months
measure: Last pain score in the post-anesthesia care unit
timeFrame: Immediately before leaving the post-anesthesia care unit, up to 1 day
measure: Total morphine equivalents of opioids given in the post-anesthesia care unit
timeFrame: During post-anesthesia care unit stay, up to 1 week
measure: Time first opioid given in the post-anesthesia care unit
timeFrame: The time the first opioid medication is given to the patient in the post-anesthesia care unit, up to 1 week
measure: Last pain score prior to hospital discharge
timeFrame: Immediately before hospital discharge
measure: Total amount of morphine equivalents during hospital stay
timeFrame: Duration of the hospital length of stay, up to 3 months
measure: The average pain score at 3 month follow-up
timeFrame: one week prior to end of 3 month follow-up
measure: The average pain score at 12 month follow-up
timeFrame: one week prior to end of 12 month follow-up
measure: Number of days with delirium
timeFrame: Duration of the hospital stay, up to 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
Study officials:
affiliation: Mercy Hospital of Baltimore
name: Charles C Edwards, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Charles Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.