Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA
NCT ID: NCT02656901
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2016-01-31
2016-06-30
Brief Summary
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The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs younger surgical patients.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Auto Total endovenous anesthesia
The closed loop delivering as already approved by ClinicalTrials.gov Identifier: NCT00392158
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
Manual Desflurane anesthesia
The anesthesia will be maintained with desflurane to target the BIS of 50.
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
Manual sevoflurane anesthesia
The anesthesia will be maintained with sevoflurane to target the BIS of 50.
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.
Manual total endovenous anestesia
In ManualTIVA group, the anesthesia will be maintained with propofol to target the BIS of 50
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.
Interventions
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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
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
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective urologic surgery under general anesthesia expected 2 hours
* American Society of Anesthesiology physical status II- III
Exclusion Criteria
* Patients with clinically significant cardiopulmonary, hepatic, renal disorders, neurological, psychiatric or metabolic disease
* Patients unable to read and write and with impaired hearing
18 Years
ALL
No
Sponsors
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University of Foggia
OTHER
Responsible Party
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Cotoia Antonella
Prof.
Principal Investigators
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Antonella Cotoia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Foggia
Locations
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University of Foggia
Foggia, Foggia, Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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43/CE/2014
Identifier Type: -
Identifier Source: org_study_id
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