Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Device: auto total endovenous anesthesia
* Device: Manual Desflurane anesthesia
* Device: Manual Sevoflurane anesthesia
* Device: Manual total endovenous anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Auto Total endovenous anesthesia<br>The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158 | Device: auto total endovenous anesthesia<br>* 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<br>* Other names: AutoTIVA;|
| Sham Comparator: Manual Desflurane anesthesia<br>The anesthesia will be maintained with desflurane to target the BIS of 50. | Device: Manual Desflurane anesthesia<br>* 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<br>* Other names: DES;|
| Sham Comparator: Manual sevoflurane anesthesia<br>The anesthesia will be maintained with sevoflurane to target the BIS of 50. | Device: Manual Sevoflurane anesthesia<br>* 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.<br>* Other names: SEVO;|
| Sham Comparator: Manual total endovenous anestesia<br>In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50 | Device: Manual total endovenous anesthesia<br>* 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.<br>* Other names: Manual TIVA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the Mini-Mental test examination score 15 min post 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. | 15 minutes before anesthetic procedures and 15 min after the end of general anesthesia |