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

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ClinicalTrials.gov Identifier: NCT02656901
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Cotoia Antonella, 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.


Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Device: auto total endovenous anesthesia Device: Manual Desflurane anesthesia Device: Manual Sevoflurane anesthesia Device: Manual total endovenous anesthesia Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Official Title: Incidence of Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: Auto Total endovenous anesthesia
The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158
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
Other Name: AutoTIVA

Sham Comparator: Manual Desflurane anesthesia
The anesthesia will be maintained with desflurane to target the BIS of 50.
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
Other Name: DES

Sham Comparator: Manual sevoflurane anesthesia
The anesthesia will be maintained with sevoflurane to target the BIS of 50.
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.
Other Name: SEVO

Sham Comparator: Manual total endovenous anestesia
In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50
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.
Other Name: Manual TIVA




Primary Outcome Measures :
  1. Change from baseline of the Mini-Mental test examination score 15 min post anesthesia [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656901


Locations
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Italy
University of Foggia
Foggia, Italy, 71122
Sponsors and Collaborators
University of Foggia
Investigators
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Principal Investigator: Antonella Cotoia, MD, PhD University of Foggia

Publications of Results:
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Responsible Party: Cotoia Antonella, Prof., University of Foggia
ClinicalTrials.gov Identifier: NCT02656901     History of Changes
Other Study ID Numbers: 43/CE/2014
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anesthetics
Sevoflurane
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General