Association of EEG Parameters with Postoperative Delirium in Patient's with Parkinson's Disease

NCT06809556 | Not Yet Recruiting

• 1 other identifier: POD in Parkinson's Patients
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with Parkinson's disease seem prone to developing postoperative delirium after surgery, the causes of which remain understudied and multifactorial. Anesthetic management remains challenging due to the changes in neurotransmitter levels in these patients which translate to altered drug effects. Avoiding excessive anesthesia is essential. Processed electroencephalography (EEG) is used worldwide along with our centre to monitor depth of anesthesia. It is non-invasive and easy to use. Some EEG patterns like "burst suppression" are easily identifiable and indicate that the brain has fallen into an excessively low metabolic state, which could mean increased anesthetic sensitivity. Appearance of "burst suppression" can predict delirium in non-neurosurgical procedures, but this has never been studied during surgery for deep brain stimulator insertion in Parkinson's disease patients. Through this study we wish to observe the association of EEG parameters with the development of postoperative delirium in this subset of the population.This has the capacity to change anesthetic practice by being mindful of the fragile brain of such patients and individualizing drug dosing for each patient to improve outcomes and reduce hospital stay.

Conditions

Post Operative Delirium; Parkinson Disease

Keywords

post operative delirium; Parklinson's Disease; EEG

Outcome Measures

Primary Outcomes (1)

• Identification and quantification of the association between the presence of intraoperative burst suppression with the incidence of postoperative delirium

  Identification and quantification of the association between the presence of intraoperative burst suppression with the incidence of postoperative delirium. This will be measured by evaluating the presence of burst suppression readings found during intraoperative EEG monitoring and determining whether the readings are associated with the development of postoperative delirium (measured by the administration of the 3D CAM and MoCA tools).

  During surgery to 24 hours postoperative

Secondary Outcomes (1)

• Determining the association of postoperative delirium with other parameters on perioperative processed EEG

  During surgery to 24 hours postoperative

Study Arms (1)

EEG (electroencephalogram) monitoring of Parkinson's patients undergoing deep brain stimulation

Parkinson's patients undergoing deep brain stimulation (DBS). Patients will undergo DBS according to institutional protocol and monitoring via EEG will be used to detect burst suppression signals. Patients will undergo cognitive testing via completion of the 3D CAM (3-minute diagnostic interview for confusion assessment method-defined delirium) tool within 15 minutes of arriving to the surgical recovery area after the completion of surgery, discharge from the recovery area, and 24 hours postoperatively. The patients' MoCA (Montreal Cognitive Assessment) score would also be assessed at 24 hours postoperatively.

Other: EEG (electroencephalogram) monitoring of Parkinson's patients undergoing deep brain stimulation

Interventions

EEG (electroencephalogram) monitoring of Parkinson's patients undergoing deep brain stimulation OTHER

Parkinson's patients undergoing deep brain stimulation (DBS) will be monitored with EEG to detect burst suppression signals during surgery and will undergo postoperative cognitive testing for postoperative delirium.

EEG (electroencephalogram) monitoring of Parkinson's patients undergoing deep brain stimulation

Eligibility Criteria

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

Study Population

Patients 18 years of age or older who have been diagnosed with Parkinson's Disease and are undergoing elective neurosurgery for implantation of DBS electrodes and implantable pulse generator (IPG) device.

You may qualify if:

• Diagnosis of Parkinson's disease
• Elective neurosurgery for implantation of DBS electrodes and implantable pulse generator (IPG) device.
• years of age or older

You may not qualify if:

• Refusal/withdrawal of consent
• Inability to place sensor/ record EEG for the entire duration of surgery
• Emergency surgery
• Redo surgery
• Preoperative delirium (defined as per 3D CAM score)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (11)

• Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.

  PMID: 37819663 BACKGROUND

• Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.

  PMID: 18577850 BACKGROUND

• Lawson RA, McDonald C, Burn DJ. Defining delirium in idiopathic Parkinson's disease: A systematic review. Parkinsonism Relat Disord. 2019 Jul;64:29-39. doi: 10.1016/j.parkreldis.2018.09.025. Epub 2018 Sep 26.

  PMID: 30279060 BACKGROUND

• Lawson RA, Richardson SJ, Yarnall AJ, Burn DJ, Allan LM. Identifying delirium in Parkinson disease: A pilot study. Int J Geriatr Psychiatry. 2020 May;35(5):547-552. doi: 10.1002/gps.5270. Epub 2020 Feb 7.

  PMID: 31994774 BACKGROUND

• Carlson JD, Neumiller JJ, Swain LD, Mark J, McLeod P, Hirschauer J. Postoperative delirium in Parkinson's disease patients following deep brain stimulation surgery. J Clin Neurosci. 2014 Jul;21(7):1192-5. doi: 10.1016/j.jocn.2013.12.007. Epub 2014 Jan 2.

  PMID: 24518269 BACKGROUND

• Tanaka M, Tani N, Maruo T, Oshino S, Hosomi K, Saitoh Y, Kishima H. Risk Factors for Postoperative Delirium After Deep Brain Stimulation Surgery for Parkinson Disease. World Neurosurg. 2018 Jun;114:e518-e523. doi: 10.1016/j.wneu.2018.03.021. Epub 2018 Mar 9.

  PMID: 29530688 BACKGROUND

• Astalosch M, Mousavi M, Ribeiro LM, Schneider GH, Stuke H, Haufe S, Borchers F, Spies C, von Hofen-Hohloch J, Al-Fatly B, Ebersbach G, Franke C, Kuhn AA, Kubler-Weller D. Risk Factors for Postoperative Delirium Severity After Deep Brain Stimulation Surgery in Parkinson's Disease. J Parkinsons Dis. 2024;14(6):1175-1192. doi: 10.3233/JPD-230276.

  PMID: 39058451 BACKGROUND

• Likhvantsev VV, Berikashvili LB, Smirnova AV, Polyakov PA, Yadgarov MY, Gracheva ND, Romanova OE, Abramova IS, Shemetova MM, Kuzovlev AN. Intraoperative electroencephalogram patterns as predictors of postoperative delirium in older patients: a systematic review and meta-analysis. Front Aging Neurosci. 2024 May 13;16:1386669. doi: 10.3389/fnagi.2024.1386669. eCollection 2024.

  PMID: 38803541 BACKGROUND

• Kinoshita H, Saito J, Kushikata T, Oyama T, Takekawa D, Hashiba E, Sawa T, Hirota K. The Perioperative Frontal Relative Ratio of the Alpha Power of Electroencephalography for Predicting Postoperative Delirium After Highly Invasive Surgery: A Prospective Observational Study. Anesth Analg. 2023 Dec 1;137(6):1279-1288. doi: 10.1213/ANE.0000000000006424. Epub 2023 Mar 14.

  PMID: 36917508 BACKGROUND

• Serrano-Duenas M, Bleda MJ. Delirium in Parkinson's disease patients. a five-year follow-up study. Parkinsonism Relat Disord. 2005 Sep;11(6):387-92. doi: 10.1016/j.parkreldis.2005.05.002.

  PMID: 16111911 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Parkinson Disease

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; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sujoy Banik, MD

  Western University, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sujoy Banik, MD

CONTACT

5196858500; sujoy.banik@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share