Shaping Anesthetic Techniques to Reduce Post-operative Delirium
NCT03133845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2020-06-18
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.
Conditions
- Delirium
- Lumbar Radiculopathy
- Lumbar Osteoarthritis
- Lumbar Spine Disc Degeneration
Interventions
- PROCEDURE
-
Light sedation with propofol
Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
- PROCEDURE
-
Induction with propofol
Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
- PROCEDURE
-
Maintenance anesthetic using a volatile anesthetic
Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
- PROCEDURE
-
Muscle relaxant during maintenance anesthesia
Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
- PROCEDURE
-
Pain control with fentanyl
Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
- PROCEDURE
-
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.
- PROCEDURE
-
Spinal Anesthesia
Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
- PROCEDURE
-
Midazolam administered during spinal anesthesia
Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
- PROCEDURE
-
Cerebrospinal fluid collection
8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
- PROCEDURE
-
Administration of intrathecal morphine
Patient may receive intrathecal morphine for post-operative pain control.
Sponsors & Collaborators
-
Mercy Medical Center
collaborator OTHER - lead OTHER
Principal Investigators
-
Charles C Edwards, MD · Mercy Hospital of Baltimore
-
Charles Brown, MD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2020-05-25
- Completion
- 2020-05-25
Countries
- United States
Study Locations
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