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

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
auto total endovenous anesthesia
Manual Desflurane anesthesia
Manual Sevoflurane anesthesia
Manual total endovenous anesthesia
Sponsored by
University of Foggia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Foggia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Sham Comparator

Sham Comparator

Arm Label

Auto Total endovenous anesthesia

Manual Desflurane anesthesia

Manual sevoflurane anesthesia

Manual total endovenous anestesia

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline of the Mini-Mental test examination score 15 min post 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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2016
Last Updated
July 3, 2016
Sponsor
University of Foggia
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1. Study Identification

Unique Protocol Identification Number
NCT02656901
Brief Title
Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
Official Title
Incidence of Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Foggia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auto Total endovenous anesthesia
Arm Type
Active Comparator
Arm Description
The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158
Arm Title
Manual Desflurane anesthesia
Arm Type
Sham Comparator
Arm Description
The anesthesia will be maintained with desflurane to target the BIS of 50.
Arm Title
Manual sevoflurane anesthesia
Arm Type
Sham Comparator
Arm Description
The anesthesia will be maintained with sevoflurane to target the BIS of 50.
Arm Title
Manual total endovenous anestesia
Arm Type
Sham Comparator
Arm Description
In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50
Intervention Type
Device
Intervention Name(s)
auto total endovenous anesthesia
Other Intervention Name(s)
AutoTIVA
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Manual Desflurane anesthesia
Other Intervention Name(s)
DES
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Manual Sevoflurane anesthesia
Other Intervention Name(s)
SEVO
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual total endovenous anesthesia
Other Intervention Name(s)
Manual TIVA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of the Mini-Mental test examination score 15 min post anesthesia
Description
The Mini-Mental State Examination (MMSE) test will be given 15 min before the anesthetic procedure and 15 min after the end of anesthesia.
Time Frame
15 minutes before anesthetic procedures and 15 min after the end of general anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Cotoia, MD, PhD
Organizational Affiliation
University of Foggia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Foggia
City
Foggia
ZIP/Postal Code
71122
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16571963
Citation
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
Results Reference
result
PubMed Identifier
21233500
Citation
Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
Results Reference
result
PubMed Identifier
18662642
Citation
Liu N, Chazot T, Trillat B, Michel-Cherqui M, Marandon JY, Law-Koune JD, Rives B, Fischler M; Foch Lung Transplant Group. Closed-loop control of consciousness during lung transplantation: an observational study. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):611-5. doi: 10.1053/j.jvca.2008.04.022. Epub 2008 Jun 25.
Results Reference
result
PubMed Identifier
25500680
Citation
Liu N, Lory C, Assenzo V, Cocard V, Chazot T, Le Guen M, Sessler DI, Journois D, Fischler M. Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison. Br J Anaesth. 2015 Apr;114(4):605-14. doi: 10.1093/bja/aeu401. Epub 2014 Dec 10.
Results Reference
result

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

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