Shaping Anesthetic Techniques to Reduce Post-operative Delirium (SHARP)

Johns Hopkins University

Status: Completed

Conditions: Delirium; Lumbar Osteoarthritis; Lumbar Radiculopathy; Lumbar Spine Disc Degeneration

Treatments: Procedure: Muscle relaxant during maintenance anesthesia; Procedure: Light sedation with propofol; Procedure: Spinal Anesthesia; Procedure: Midazolam administered during spinal anesthesia; Procedure: Maintenance anesthetic using a volatile anesthetic; Procedure: Administration of intrathecal morphine; Procedure: Induction with propofol; Procedure: Pain control with fentanyl; Procedure: Cerebrospinal fluid collection; Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03133845

IRB00113655

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 218 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 2 patient groups

General anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Induction with propofol

Procedure: Maintenance anesthetic using a volatile anesthetic

Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia

Procedure: Pain control with fentanyl

Procedure: Administration of intrathecal morphine

Procedure: Muscle relaxant during maintenance anesthesia

Procedure: Cerebrospinal fluid collection

Spinal anesthesia with light sedation

Experimental group

Description:

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.

Treatment:

Procedure: Light sedation with propofol

Procedure: Midazolam administered during spinal anesthesia

Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia

Procedure: Administration of intrathecal morphine

Procedure: Cerebrospinal fluid collection

Procedure: Spinal Anesthesia