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

Not Applicable

Completed

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Device: Manual Desflurane anesthesia; Device: auto total endovenous anesthesia; Device: Manual Sevoflurane anesthesia; Device: Manual total endovenous anesthesia

• Registration Number: NCT02656901
• Lead Sponsor: University of Foggia

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Last Update Submitted: 2016-07-03
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Desflurane anesthesia	Manual Desflurane anesthesia	The anesthesia will be maintained with desflurane to target the BIS of 50.
Auto Total endovenous anesthesia	auto total endovenous anesthesia	The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158
Manual sevoflurane anesthesia	Manual Sevoflurane anesthesia	The anesthesia will be maintained with sevoflurane to target the BIS of 50.
Manual total endovenous anestesia	Manual total endovenous anesthesia	In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Foggia; 🇮🇹 Foggia, Italy