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CompletedNCT03133845

Shaping Anesthetic Techniques to Reduce Post-operative Delirium

Shaping Anesthetic Techniques to Reduce Post-Operative Delirium

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
218 (estimated)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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%.

Conditions

Interventions

TypeNameDescription
PROCEDURELight sedation with propofolPatients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
PROCEDUREInduction with propofolPatients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
PROCEDUREMaintenance anesthetic using a volatile anestheticPatients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
PROCEDUREMuscle relaxant during maintenance anesthesiaPatients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
PROCEDUREPain control with fentanylPatients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
PROCEDUREBispectral Index (BIS) monitoring for depth of anesthesiaAll patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.
PROCEDURESpinal AnesthesiaPatients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
PROCEDUREMidazolam administered during spinal anesthesiaMidazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
PROCEDURECerebrospinal fluid collection8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
PROCEDUREAdministration of intrathecal morphinePatient may receive intrathecal morphine for post-operative pain control.

Timeline

Start date
2015-10-01
Primary completion
2020-05-25
Completion
2020-05-25
First posted
2017-04-28
Last updated
2020-06-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03133845. Inclusion in this directory is not an endorsement.