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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

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02656901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
Official Title  ICMJE Incidence of Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Condition  ICMJE Postoperative Cognitive Dysfunction
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Auto Total endovenous anesthesia
    The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158
    Intervention: Device: auto total endovenous anesthesia
  • Sham Comparator: Manual Desflurane anesthesia
    The anesthesia will be maintained with desflurane to target the BIS of 50.
    Intervention: Device: Manual Desflurane anesthesia
  • Sham Comparator: Manual sevoflurane anesthesia
    The anesthesia will be maintained with sevoflurane to target the BIS of 50.
    Intervention: Device: Manual Sevoflurane anesthesia
  • Sham Comparator: Manual total endovenous anestesia
    In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50
    Intervention: Device: Manual total endovenous anesthesia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2016)
132
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
84
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656901
Other Study ID Numbers  ICMJE 43/CE/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cotoia Antonella, University of Foggia
Study Sponsor  ICMJE University of Foggia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonella Cotoia, MD, PhD University of Foggia
PRS Account University of Foggia
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP