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

University of Foggia

Status: Completed

Conditions: Postoperative Cognitive Dysfunction

Treatments: Device: Manual total endovenous anesthesia; Device: auto total endovenous anesthesia; Device: Manual Desflurane anesthesia; Device: Manual Sevoflurane anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02656901

43/CE/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 4 patient groups

Auto Total endovenous anesthesia

Active Comparator group

Description:

The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158

Treatment:

Device: auto total endovenous anesthesia

Manual Desflurane anesthesia

Sham Comparator group

Description:

The anesthesia will be maintained with desflurane to target the BIS of 50.

Treatment:

Device: Manual Desflurane anesthesia

Manual sevoflurane anesthesia

Sham Comparator group

Description:

The anesthesia will be maintained with sevoflurane to target the BIS of 50.

Treatment:

Device: Manual Sevoflurane anesthesia

Manual total endovenous anestesia

Sham Comparator group

Description:

In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50

Treatment:

Device: Manual total endovenous anesthesia