N/A
N=199
Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly
Lumbar Spondylosis · Cervical Spondylosis · Hip Osteoarthritis · Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00788008 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change in Neurocognitive Performance (Z-score) — .09; -.20; -.42; .01 z score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- inhalation anesthesia with isoflurane vs. TIVA with propofol (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neurocognitive Performance (Z-score) |
.09; -.20; -.42; .01 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00788008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.