Cognitive Impairment
Conditions
Keywords
dexmedetomidine, serum Tau-217 protein, cognitive dysfunction
Brief summary
To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia.
Detailed description
to assess the effect of dexmedetomidine on serum Tau-217 protein through measuring serum Tau-217 protein preoperative and postoperative period and comparing the 2 measurements , assessing the cognitive dysfunction in the elderly patients and comparing the correlation between the cognitive dysfunction with serum tau-217 level also assessing the neuroprotective effect of dexmedetomidine on postoperative cognitive dysfunction and its relation with serum Tau-217 level.
Interventions
DRUGDexmedetomidine Hydrochloride
dexmedetomidine effect in preventing postoperative cognitive dysfunction on elderly patients undergoing major surgery guided with serum Tau-217 protein.
OTHERnormal saline
normal saline will be administrated in placebo group
Sponsors
Minia University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged \> 65 years old, both genders, Basal Metabolic Index range 18.5 to less than 35 American Society of Anesthesiologists I - III with Glasgow Coma Scale 14-15 undergoing major surgery under general anesthesia.
Exclusion criteria
* Patients will be excluded if they refused the enrollment in our study, Glasgow Coma Scale\<14 or if there is severe cardiac, liver or renal disease, patients have Alzehimer's Disease or any of the psychotic diseases, poorly educated patients and if there is any sensitivity to given drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the effect of dexmedetomidine on serum Tau-217 protein value. | 2 years | estimation of the effect of dexmedetomidine on serum Tau-217 protein in postoperative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group. | 2 years | evaluation of the postoperative cognitive dysfunction by Mini Mental State Scale as \>25 is recorded normal while less than \<24 is positive for cognitive dysfunction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours | 2 years | Heart Rate will be measured in beat/min |
| Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours | 2 years | Mean Arterial Blood Pressure will be measured in mmHg/min |
Countries
Egypt
Contacts
Primary ContactArwa Essam Anwar, Assistant Lecturer
Backup ContactAmr Nady Abd Elrazik, Assistant Lecturer
Outcome results
None listed