Association Between Burst Suppression During Anesthetic Induction With Postoperative Delirium in Cardiac Surgery

NCT04713644 | Completed

• 1 other identifier: 200923005
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The population over 65 years of age will be increasingly exposed to surgical procedures that require general anesthesia. Postoperative delirium is one of the main causes of preventable postoperative morbidity in the elderly population and is a frequent event after cardiac surgery with extracorporeal circulation. The excess administration of anesthetics that potentiate the Gamma Aminobutyric A receptor, such as propofol, are related to an intraoperative electroencephalographic pattern called burst suppression that has been associated with postoperative delirium. It is unknown whether this pattern is secondary to a relative overdose of anesthetics or rather corresponds to a characteristic of a vulnerable brain that is suppressed at doses at which other patients are not. Our objective will be to determine whether burst suppression in people over 65 years of age during a standardized anesthetic induction with propofol for cardiac surgery with extracorporeal circulation is associated with postoperative delirium compared to older people who do not present it.

Conditions

Postoperative Delirium

Keywords

Burst Suppression; Postoperative Delirium; Electroencephalography; Propofol; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Delirium

  Positive Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or structured chart review

  Up to 72 hours after surgery (3 postoperative days), CAM or CAM-ICU assessed twice daily (AM/PM)

Secondary Outcomes (6)

• Burst suppression during anesthesia induction

  20 minutes after standardized propofol administration

• Burst suppression during cardiopulmonary bypass

  Through Cardiopulmonary bypass time defined as time between connection to pump to disconnection, an average of 120 minutes

• Preoperative Cognitive Status

  Preoperative anesthetic evaluation

• Preoperative Frailty

  Preoperative anesthetic evaluation

• Electroencephalogram (EEG) Alpha Power/Total Power

  Stable anesthetic period before cardiopulmonary bypass and 20 minutes after propofol induction

Study Arms (2)

Burst Suppression

Patients who present burst suppression after standardized propofol administration during anesthetic induction

Drug: Standardized Propofol Administration

No Burst Suppression

Patients who did not present burst suppression after standardized propofol administration during anesthetic induction

Drug: Standardized Propofol Administration

Interventions

Standardized Propofol Administration DRUG

Intravenous bolus propofol administration of 0.5 mg/Kg dose, plus 0.5 mg/Kg extra if necessary

Burst Suppression; No Burst Suppression

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 65 years of age undergoing cardiac surgery with cardiopulmonary bypass.

You may qualify if:

• Patients ≥ 65 years of age
• Undergoing elective cardiac surgery requiring extracorporeal circulation (coronary artery bypass, univalvular replacement, bivalvular and coronary artery bypass plus univalvular replacement)
• American Society of Anesthesiologists Physical Status II-III.

You may not qualify if:

• Body Mass Index \> 35 and \<18 Kg / m2
• Severe ventricular dysfunction (EF \< 30% or severe dysfunction measured in ventriculography)
• Emergency surgery
• Chronic use of alcohol or drug abuse
• History of Stroke
• Neurological diseases
• Endocarditis
• Positive screening for preoperative delirium.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Related Publications (18)

• Soreide K, Wijnhoven BP. Surgery for an ageing population. Br J Surg. 2016 Jan;103(2):e7-9. doi: 10.1002/bjs.10071. No abstract available.

  PMID: 26771471 BACKGROUND

• Deiner S, Westlake B, Dutton RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr Soc. 2014 May;62(5):829-35. doi: 10.1111/jgs.12794. Epub 2014 Apr 14.

  PMID: 24731176 BACKGROUND

• Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

  PMID: 23992774 BACKGROUND

• Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.

  PMID: 28973626 BACKGROUND

• Boone MD, Sites B, von Recklinghausen FM, Mueller A, Taenzer AH, Shaefi S. Economic Burden of Postoperative Neurocognitive Disorders Among US Medicare Patients. JAMA Netw Open. 2020 Jul 1;3(7):e208931. doi: 10.1001/jamanetworkopen.2020.8931.

  PMID: 32735336 BACKGROUND

• Oh ES, Akeju O, Avidan MS, Cunningham C, Hayden KM, Jones RN, Khachaturian AS, Khan BA, Marcantonio ER, Needham DM, Neufeld KJ, Rose L, Spence J, Tieges Z, Vlisides P, Inouye SK; NIDUS Writing Group. A roadmap to advance delirium research: Recommendations from the NIDUS Scientific Think Tank. Alzheimers Dement. 2020 May;16(5):726-733. doi: 10.1002/alz.12076. Epub 2020 Apr 14.

  PMID: 32291901 BACKGROUND

• Goldberg TE, Chen C, Wang Y, Jung E, Swanson A, Ing C, Garcia PS, Whittington RA, Moitra V. Association of Delirium With Long-term Cognitive Decline: A Meta-analysis. JAMA Neurol. 2020 Nov 1;77(11):1373-1381. doi: 10.1001/jamaneurol.2020.2273.

  PMID: 32658246 BACKGROUND

• Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194.

  PMID: 29621031 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

• Fritz BA, Maybrier HR, Avidan MS. Intraoperative electroencephalogram suppression at lower volatile anaesthetic concentrations predicts postoperative delirium occurring in the intensive care unit. Br J Anaesth. 2018 Jul;121(1):241-248. doi: 10.1016/j.bja.2017.10.024. Epub 2018 Jan 17.

  PMID: 29935578 BACKGROUND

• Pedemonte JC, Plummer GS, Chamadia S, Locascio JJ, Hahm E, Ethridge B, Gitlin J, Ibala R, Mekonnen J, Colon KM, Westover MB, D'Alessandro DA, Tolis G, Houle T, Shelton KT, Qu J, Akeju O. Electroencephalogram Burst-suppression during Cardiopulmonary Bypass in Elderly Patients Mediates Postoperative Delirium. Anesthesiology. 2020 Aug;133(2):280-292. doi: 10.1097/ALN.0000000000003328.

  PMID: 32349072 BACKGROUND

• Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.

  PMID: 25928189 BACKGROUND

• Brown CH 4th, Max L, LaFlam A, Kirk L, Gross A, Arora R, Neufeld K, Hogue CW, Walston J, Pustavoitau A. The Association Between Preoperative Frailty and Postoperative Delirium After Cardiac Surgery. Anesth Analg. 2016 Aug;123(2):430-5. doi: 10.1213/ANE.0000000000001271.

  PMID: 27096563 BACKGROUND

• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

  PMID: 26275092 BACKGROUND

• Plummer GS, Ibala R, Hahm E, An J, Gitlin J, Deng H, Shelton KT, Solt K, Qu JZ, Akeju O. Electroencephalogram dynamics during general anesthesia predict the later incidence and duration of burst-suppression during cardiopulmonary bypass. Clin Neurophysiol. 2019 Jan;130(1):55-60. doi: 10.1016/j.clinph.2018.11.003. Epub 2018 Nov 16.

  PMID: 30476711 BACKGROUND

• Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.

  PMID: 21190458 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

• Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.

  PMID: 30721296 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

C-reactive protein (CRP) serum level

MeSH Terms

Conditions

Emergence Delirium

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

Study Officials

• Juan C Pedemonte, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 19, 2021
• Study Start: March 1, 2021
• Primary Completion: February 28, 2024
• Study Completion: September 1, 2024
• Last Updated: May 31, 2025

Record last verified: 2024-11

Locations

CL (1)