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

NCT02656901 | Completed

• 1 other identifier: 43/CE/2014
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes before anesthetic procedures and 15 min after the end of general anesthesia

Study Arms (4)

Auto Total endovenous anesthesia

ACTIVE COMPARATOR

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

Device: auto total endovenous anesthesia

Manual Desflurane anesthesia

SHAM COMPARATOR

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

Device: Manual Desflurane anesthesia

Manual sevoflurane anesthesia

SHAM COMPARATOR

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

Device: Manual Sevoflurane anesthesia

Manual total endovenous anestesia

SHAM COMPARATOR

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

Device: Manual total endovenous anesthesia

Interventions

auto total endovenous anesthesia DEVICE

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

Also known as: AutoTIVA

Auto Total endovenous anesthesia

Manual Desflurane anesthesia DEVICE

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

Also known as: DES

Manual Desflurane anesthesia

Manual Sevoflurane anesthesia DEVICE

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.

Also known as: SEVO

Manual sevoflurane anesthesia

Manual total endovenous anesthesia DEVICE

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.

Also known as: Manual TIVA

Manual total endovenous anestesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged above 18 years
• Patients undergoing elective urologic surgery under general anesthesia expected 2 hours
• American Society of Anesthesiology physical status II- III

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

University of Foggia

Foggia, Foggia, 71122, Italy

Location

Related Publications (4)

• 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.

  PMID: 16571963 RESULT

• 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.

  PMID: 21233500 RESULT

• 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.

  PMID: 18662642 RESULT

• 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.

  PMID: 25500680 RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Antonella Cotoia, MD, PhD

  University of Foggia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)