Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium

NCT03705728 | Unknown DMC

• 1 other identifier: AG-DPO
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.

Conditions

Postoperative Delirium; Elderly Patient; General Anesthetic Drug Adverse Reaction

Keywords

anesthesia, general; postoperative delirium; postoperative nausea and vomiting; elderly; total intravenous anesthesia; closed-loop anesthesia; EEG monitoring; propofol; remifentanil; sevoflurane

Outcome Measures

Primary Outcomes (1)

• Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia

  occurrence of POD as measured by the Nursing Delirium Screening Scale The Nursing Delirium Scale Symptom Symptom rating Disorientation 0 points 1 point 2 points Inappropriate behavior 0 points 1 point 2 points Inappropriate communication 0 points 1 point 2 points Illusion/hallucination 0 points 1 point 2 points Psychomotot retardation 0 points 1 point 2 points Total score ≤ 2 points \> 2 points Delirium No Yes

  Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively

Study Arms (2)

Intravenous group

EXPERIMENTAL

Propofol \& remifentanil administration using the closed-loop controller with the "Easy-TIVA" platfrom.

Drug: Propofol; Drug: Remifentanil automatic

volatile anesthesia group

ACTIVE COMPARATOR

Sevoflurane will be administered manually according to the BIS values. Remifentanil will be administered manually using a Target Controlled Infusion pump using the Minto model.

Drug: Sevoflurane; Drug: Remifentanil manual

Interventions

Propofol DRUG

Propofol will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval

Intravenous group

Sevoflurane DRUG

Sevoflurane will be manually administered to maintain the BIS value within the 40-60 interval

volatile anesthesia group

Remifentanil automatic DRUG

Remifentanil will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval

Intravenous group

Remifentanil manual DRUG

Remifentanil will be manually administered to maintain the BIS value within the 40-60 interval

volatile anesthesia group

Eligibility Criteria

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

You may qualify if:

• age \> 59 year
• Informed written consent before enrolment;
• Procedure duration \> 60 min.
• Speaking French
• Possible contact one-month following surgery

You may not qualify if:

• Contraindication of brain monitoring (intracranial surgery), pace-maker.
• Propofol or remifentanil allergy.
• Patients under guardianship

Sponsors & Collaborators

• Centre Clinical, France: lead

Study Sites (1)

Centre Clinical

Soyaux, Charente, 16800, France

RECRUITING

Related Publications (12)

• American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.

  PMID: 25535170 BACKGROUND

• Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.

  PMID: 19106695 BACKGROUND

• Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

  PMID: 22762316 BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.

  PMID: 23027226 BACKGROUND

• Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.

  PMID: 23539235 BACKGROUND

• Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

  PMID: 26418126 BACKGROUND

• 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 BACKGROUND

• Besch G, Liu N, Samain E, Pericard C, Boichut N, Mercier M, Chazot T, Pili-Floury S. Occurrence of and risk factors for electroencephalogram burst suppression during propofol-remifentanil anaesthesia. Br J Anaesth. 2011 Nov;107(5):749-56. doi: 10.1093/bja/aer235. Epub 2011 Aug 8.

  PMID: 21828343 BACKGROUND

• 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 BACKGROUND

• Orliaguet GA, Benabbes Lambert F, Chazot T, Glasman P, Fischler M, Liu N. Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study. Anesthesiology. 2015 Apr;122(4):759-67. doi: 10.1097/ALN.0000000000000577.

  PMID: 25545655 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Postoperative Nausea and Vomiting

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Central Study Contacts

Xavier Paqueron, MD PhD

CONTACT

+33545979562; xavier.paqueron@orange.fr

Thierry Chazot, MD

CONTACT

+33629820241; tchazot@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 15, 2018
• Study Start: May 30, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

FR (1)