Knee Osteoarthritis Clinical Trial
Official title:
Does Inhalational Anesthesia Accelerate Postoperative Cognitive Decline?
Verified date | March 2015 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - patients (aged 65 years or older) scheduled for elective spine or major joint replacement (total hip or total knee arthroplasty) at Duke University Medical Center or the Durham VA Medical Center Exclusion Criteria: - not fluent in English and able to comprehend the English language - have severe visual or auditory handicaps - Carry a diagnosis of dementia or score < 18 on the Mini-Mental State Examination (MMSE) as calculated from the Modified Mini-Mental State (3MS) (see D4 below) - have allergies to eggs, propofol, isoflurane, fentanyl, remifentanil, or pregabalin |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | VAMC | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Neurocognitive Performance (Z-score) | Mean change on composite scores (z-score) for memory and executive function measures. Memory measures: Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised. Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination. The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range. Higher scores (and thus positive change value) indicate an improvement of function. |
3 months post operatively | Yes |
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