Postoperative Cognitive Dysfunction
Conditions
Brief summary
This study is designed to test the hypothesis that closed loop system reduces post operative cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane, total intravenous anesthesia manually guided by bispectral index in urologic surgical patients. The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs younger surgical patients.
Detailed description
Postoperative cognitive dysfunction (POCD) is a transient cognitive impairment manifested by compromised memory and concentration with altered performance on intellectual tasks that can affect patients of any age but it is more frequent in advanced age people after anesthesia. Recently clinical research has demonstrated the efficacy of computer- controlled endovenous drug delivery system guided by bispectral index score (BIS) of the electroencephalogram as the control variable. The BIS closed loop (CL) titration of propofol and remifentanyl target control infusion provides clinically adequate anesthesia with stability of cardiovascular parameters and favorable patients outcomes, including decreasing drug consumption and shortened postoperative recovery times when compared with manual control infusion.
Interventions
DEVICEauto total endovenous anesthesia
a closed-loop controller guided by the BIS steering the infusion pumps (Alaris Medical UK Ldt, Hants, Uk) as already approved by ClinicalTrials.gov Identifier: NCT00392158
DEVICEManual Desflurane anesthesia
General anesthesia will be maintained with desflurane (Baxter D-Vapor Desflurane Vaporiser) to obtain a BIS value as close as possible to 50 and between 40
DEVICEManual Sevoflurane anesthesia
General anesthesia will be maintained with sevoflurane ( Baxter Vapour 2000 Sevoflurane Vapouriser) to obtain a BIS value as close as possible to 50 and between 40 and 60.
DEVICEManual total endovenous anesthesia
In ManualTIVA group, the anesthesia will be maintained with propofol (Injectomat TIVA Agilia, Fresenius Kabi, Bad Hamburg, Germany) to obtain a BIS value as close as possible to 50 and between 40 and 60.
Sponsors
University of Foggia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged above 18 years * Patients undergoing elective urologic surgery under general anesthesia expected 2 hours * American Society of Anesthesiology physical status II- III
Exclusion criteria
* Patients with body mass index greater than 30, * Patients with clinically significant cardiopulmonary, hepatic, renal disorders, neurological, psychiatric or metabolic disease * Patients unable to read and write and with impaired hearing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of the Mini-Mental test examination score 15 min post anesthesia | 15 minutes before anesthetic procedures and 15 min after the end of general anesthesia | The Mini-Mental State Examination (MMSE) test will be given 15 min before the anesthetic procedure and 15 min after the end of anesthesia. |
Countries
Italy
Outcome results
None listed