NCT03133845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

4.7 years

First QC Date

October 23, 2015

Last Update Submit

June 17, 2020

Conditions

DeliriumLumbar RadiculopathyLumbar OsteoarthritisLumbar Spine Disc Degeneration

Keywords

deliriumelderlylumbarsurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

  • Assessment of cognitive status at 3 months using the Verbal Fluency Test

    3 months after surgery

  • 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 Instrumental Activities of Daily Living (IADL) test.

    3 months after surgery

  • Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.

    1 year after surgery

  • Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)

    3 months after surgery

  • +23 more secondary outcomes

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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 propofolProcedure: Maintenance anesthetic using a volatile anestheticProcedure: Muscle relaxant during maintenance anesthesiaProcedure: Pain control with fentanylProcedure: Bispectral Index (BIS) monitoring for depth of anesthesiaProcedure: Cerebrospinal fluid collectionProcedure: Administration of intrathecal morphine

Spinal anesthesia with light sedation

EXPERIMENTAL

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: Light sedation with propofolProcedure: Bispectral Index (BIS) monitoring for depth of anesthesiaProcedure: Spinal AnesthesiaProcedure: Midazolam administered during spinal anesthesiaProcedure: Cerebrospinal fluid collectionProcedure: Administration of intrathecal morphine

Interventions

Light sedation with propofolPROCEDURE

Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.

Spinal anesthesia with light sedation
Induction with propofolPROCEDURE

Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.

General anesthesia
Maintenance anesthetic using a volatile anestheticPROCEDURE

Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.

General anesthesia
Muscle relaxant during maintenance anesthesiaPROCEDURE

Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.

General anesthesia
Pain control with fentanylPROCEDURE

Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.

General anesthesia
Bispectral Index (BIS) monitoring for depth of anesthesiaPROCEDURE

All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.

General anesthesiaSpinal anesthesia with light sedation
Spinal AnesthesiaPROCEDURE

Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.

Spinal anesthesia with light sedation
Midazolam administered during spinal anesthesiaPROCEDURE

Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.

Spinal anesthesia with light sedation
Cerebrospinal fluid collectionPROCEDURE

8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.

General anesthesiaSpinal anesthesia with light sedation
Administration of intrathecal morphinePROCEDURE

Patient may receive intrathecal morphine for post-operative pain control.

General anesthesiaSpinal anesthesia with light sedation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

  • 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.

    PMID: 31656179DERIVED

MeSH Terms

Conditions

DeliriumRadiculopathyOsteoarthritis, Spine

Interventions

PropofolNeoadjuvant TherapyAnalgesiaFentanylAnesthesia, Spinal

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPeripheral Nervous System DiseasesNeuromuscular DiseasesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesOsteoarthritisArthritisJoint DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCombined Modality TherapyTherapeuticsAnesthesia and AnalgesiaPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnesthesia, ConductionAnesthesia

Study Officials

  • Charles C Edwards, MD

    Mercy Hospital of Baltimore

    PRINCIPAL INVESTIGATOR

  • Charles Brown, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

April 28, 2017

Study Start

October 1, 2015

Primary Completion

May 25, 2020

Study Completion

May 25, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)