Post Operative Cognitive Dysfunction
Conditions
Keywords
Cognitive function
Brief summary
Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.
Interventions
DRUGSugammadex
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged \>40 years old * ASA I-III * Patients scheduled for elective surgery with general anaesthesia.
Exclusion criteria
* Neuro-, vascular-, orthopedic- or cardiac surgery * Known psychiatric or disease of the CNS * History of craniotomy * Receiving tranquillisers or antidepressants on a regular basis pre-operatively * Alcoholism or drug dependence * History of stroke * Refusal of patient * Inability to read or write * MMSE \< 22 pre-operatively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Mini-Mental State Evaluation test | Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively) |
| Change in the clock-drawing test | Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively) |
| Change in the Isaacs set test | Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively) |
Secondary
| Measure | Time frame |
|---|---|
| Time from reversal agent administration to extubation | After reversal agent administration |
Countries
Greece
Outcome results
None listed