Postoperative Cognitive Dysfunction
Conditions
Keywords
amantadine sulphate, postoperative cognitive dysfunction, laparoscopic radical prostatectomy
Brief summary
Evaluation of the effect of preoperative intravenous administration of amantadine sulfate on the prevention of the development of early cognitive dysfunction in elderly patients undergoing laparoscopic radical prostatectomy
Detailed description
Investigators believe that the preoperative prophylactic amantadine sulphate will reduce the incidence of postoperative cognitive disfunction (POCD) in patients with laparoscopic radical prostatectomy due to the neuroprotective effect, alertness enhancing effect and neuron protective effects.
Interventions
200mg/500ml i.v. solution for infusion
DRUGPlacebo (for amantadine sulphate)
500 cc 0.9% sodium chloride
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomise double blind placebo- controlled study
Intervention model description
Patients randomly allocated to two treatment groups: Amantadine Sulphate group (Group I) and the placebo group (Group II). Participants will receive two doses of amantadine sulphate in the form of three-hour infusions. The first infusion will be administered 8 hours before the operation and the second infusion will be terminated just before the operation.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- ASA II-III Patient
Exclusion criteria
* history of disease related to central nervous system, history of psychiatric disease, history of previous open heart surgery, history of previous craniotomy, renal insufficiency, hepatic failure, history of arrhythmia pre-applied standardized Mini Mental Test (sMMT) less than 24 points
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini Menthal Test | 24 hours after surgery | cognitive function scale, Patients will be administered 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal analog Pain Scores on rest and movement | 48 hours after surgrey | A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, 48 hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible. |
Countries
Turkey (Türkiye)
Outcome results
None listed