Postoperative Cognitive Dysfunction
Conditions
Brief summary
Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.
Interventions
DRUGPreoperative modafinil + postoperative placebo
200 mg modafinil pre-operatively and placebo immediately post-operatively.
DRUGPreoperative modafinil + postoperative modafinil
200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
DRUGPreoperative placebo + postoperative placebo
Placebo pre-operatively and placebo immediately post-operatively.
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists class I or II * Elective surgery * Surgery requiring general anesthesia 4.) Control Group will be-females & males 65 and older not scheduled for any surgical procedures for at least a 3 month period.
Exclusion criteria
* Neurosurgery * Cardiac surgery * Narcotic or illicit drug abuse * Chronic opioid use * Chronic use of anxiolytics * History of pulmonary disease * C02 retention * Sleep apnea * Obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rey Auditory Verbal Learning Test (RAVLT) scores | 3 months | Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms. The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively. |
Outcome results
None listed