NCT02656901

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University of Foggia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Cognitive Dysfunction

Interventions

Type	Name	Description
DEVICE	auto 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
DEVICE	Manual 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
DEVICE	Manual 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.
DEVICE	Manual 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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2016-01-15
• Last updated: 2016-07-06

Locations

1 site across 1 country: Italy