Clinical Trial: Shaping Anesthetic Techniques to Reduce Post-operative Delirium

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Shaping Anesthetic Techniques to Reduce Post-Operative Delirium

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 Summary:

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%.


Sponsor: Johns Hopkins University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of cognitive status at 3 months using controlled oral word association test (COWAT) [ Time Frame: 3 months after surgery ]
    The participant will be administered the controlled oral word association test (COWAT) to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a specific letter. The procedure is then repeated 2 more times using two different letters. The score is the total number of different words produced for all 3 letters and will be compared to the score obtained at baseline.
  • Assessment of cognitive status at 1 year using controlled oral word association test (COWAT) [ Time Frame: 1 year after surgery ]
    The participant will be administered the controlled oral word association test (COWAT) to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a specific letter. The procedure is then repeated 2 more times using two different letters. The score is the total number of different words produced for all 3 letters. The score is the total number of different words produced for all 3 letters and will be compared to the score obtained at baseline and 3 months after surgery.
  • Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test. [ Time Frame: 3 months after surgery ]
    At 3 months, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 12-47 with 12 being high functioning and 47 being low functioning. This score will be compared to the baseline score.
  • Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test. [ Time Frame: 1 year after surgery ]
    At 1 year, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 12-47 with 12 being high functioning and 47 being low functioning. This score will be compared to the score obtained at baseline and 3 months after surgery.
  • Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12) [ Time Frame: 3 months after surgery ]
    This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.
  • Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12) [ Time Frame: 1 year after surgery ]
    This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.
  • Assessment of functional status at 3 months using the Oswestry Disability Index (ODI) [ Time Frame: 3 months after surgery ]
    This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the baseline score.
  • Assessment of functional status at 1 year using the Oswestry Disability Index (ODI) [ Time Frame: 1 year after surgery ]
    This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the scores obtained at baseline and 3 months after surgery.
  • Assessment of cognitive status at 3 months using Trail Making Test [ Time Frame: 3 months after surgery ]
    This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the score obtained at baseline.
  • Assessment of cognitive status at 1 year using Trail Making Test [ Time Frame: 1 year after surgery ]
    This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the scores obtained at baseline and 3 months after surgery.
  • Assessment of cognitive status at 3 months using the Digit Span [ Time Frame: 3 months after surgery ]
    The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-8 with 0 being short term memory impairment and 8 be no short term memory impairment. This score will be compared to the score obtained at baseline.
  • Assessment of cognitive status at 1 year using the Digit Span [ Time Frame: 1 year after surgery ]
    Same as current

    Information By: Johns Hopkins University

    Dates:
    Date Received: October 23, 2015
    Date Started: October 2015
    Date Completion: October 2019
    Last Updated: April 25, 2017
    Last Verified: April 2017