Shaping Anesthetic Techniques to Reduce Post-Operative Delirium

Johns Hopkins University1 site in 1 country218 target enrollmentOctober 2015

ConditionsDelirium Lumbar Radiculopathy Lumbar Osteoarthritis Lumbar Spine Disc Degeneration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Delirium
Sponsor: Johns Hopkins University
Enrollment: 218
Locations: 1
Primary Endpoint: Incidence of delirium
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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%.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

May 25, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)(3 months after surgery)
Maximum severity of delirium during hospital stay(Through the end of hospitalization, up to 3 months)
Total amount of morphine equivalents during hospital stay(Duration of the hospital length of stay, up to 3 months)
Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.(1 year after surgery)
Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)(1 year after surgery)
Assessment of cognitive status at 3 months using Trail Making Test(3 months after surgery)
Assessment of cognitive status at 3 months using the Digit Span(3 months after surgery)
Assessment of the cognitive status at 1 year using the Mini Mental Status Exam(1 year after surgery)
Number of participants with emergency room visit within 30 days of hospital discharge(30 days from hospital discharge)
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)
Assessment of cognitive status at 1 year using the Verbal Fluency test.(1 year after surgery)
Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)(3 months after surgery)
Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)(1 year after surgery)
Assessment of cognitive status at 1 year using Trail Making Test(1 year after surgery)
Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)(1 year after surgery)
Assessment of cognitive status at 3 months using the Verbal Fluency Test(3 months after surgery)
Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.(3 months after surgery)
Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)(3 months after surgery)
Number of participants with hospital readmissions within 30 days of discharge(30 days from hospital discharge)
The average pain score at 3 month follow-up(one week prior to end of 3 month follow-up)
Assessment of cognitive status at 1 year using the Digit Span(1 year after surgery)
Assessment of the cognitive status at 3 months using the Mini Mental Status Exam(3 months after surgery)
Number of days in hospital after surgery(Immediately after surgery until discharge, up to 3 months)
Last pain score in the post-anesthesia care unit(Immediately before leaving the post-anesthesia care unit, up to 1 day)
Total morphine equivalents of opioids given in the post-anesthesia care unit(During post-anesthesia care unit stay, up to 1 week)
The average pain score at 12 month follow-up(one week prior to end of 12 month follow-up)
Number of days with delirium(Duration of the hospital stay, up to 3 months)
Last pain score prior to hospital discharge(Immediately before hospital discharge)