The Influence of Age on EEG Signals and Consciousness During Anesthesia

NCT04765046 | Completed Results

• 1 other identifier: MDT18067TIARA
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.

Conditions

Anesthesia

Keywords

Bispectral index

Outcome Measures

Primary Outcomes (1)

• BIS50

  The Bispectral Index (BIS) value, a scale 0-100 with 0 being no brain activity and 100 being fully conscious, at which 50% of subjects are anesthetized at a level they are considered uncounscious based on the MOAA/S score of 0-2

  8 hours

Study Arms (1)

BIS™ System

OTHER

Enrolled subjects who are undergoing a standard of care elective surgery under general anesthesia, will be equipped with the BIS system to non-invasively measure and interpret brain waive activity directly related to the effects of anesthetic agents during the surgery duration.

Device: Bispectral (BIS™) Complete Monitoring System

Interventions

Bispectral (BIS™) Complete Monitoring System DEVICE

The BIS™ Complete Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.

BIS™ System

Eligibility Criteria

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

You may qualify if:

• A potential subject may be included for participation in the study if the subject has/is:
• ≥18 years of age
• American Society of Anesthesiologists (ASA) physical status I-III
• Able and willing to participate in the study and sign the informed consent form
• Will undergo non-ambulatory elective surgery under general anesthesia
• Has an expected surgery time \>2 hours

You may not qualify if:

• A potential subject will be excluded from participating in the study if the subject has/is:
• Pregnant
• Unwilling to undergo EEG measurement
• Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
• Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages.
• Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring)
• Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression
• Severe visual or auditory disorder
• Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Rambam Health Care Campus

Haifa, Israel

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Related Publications (12)

• Kanonidou Z, Karystianou G. Anesthesia for the elderly. Hippokratia. 2007 Oct;11(4):175-7.

  PMID: 19582189 BACKGROUND

• Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.

  PMID: 24937564 BACKGROUND

• Glass PS, Bloom M, Kearse L, Rosow C, Sebel P, Manberg P. Bispectral analysis measures sedation and memory effects of propofol, midazolam, isoflurane, and alfentanil in healthy volunteers. Anesthesiology. 1997 Apr;86(4):836-47. doi: 10.1097/00000542-199704000-00014.

  PMID: 9105228 BACKGROUND

• Flaishon R, Windsor A, Sigl J, Sebel PS. Recovery of consciousness after thiopental or propofol. Bispectral index and isolated forearm technique. Anesthesiology. 1997 Mar;86(3):613-9. doi: 10.1097/00000542-199703000-00013.

  PMID: 9066327 BACKGROUND

• Schwab HS, Seeberger MD, Eger EI 2nd, Kindler CH, Filipovic M. Sevoflurane decreases bispectral index values more than does halothane at equal MAC multiples. Anesth Analg. 2004 Dec;99(6):1723-1727. doi: 10.1213/01.ANE.0000136467.47996.70.

  PMID: 15562061 BACKGROUND

• Hans P, Dewandre PY, Brichant JF, Bonhomme V. Comparative effects of ketamine on Bispectral Index and spectral entropy of the electroencephalogram under sevoflurane anaesthesia. Br J Anaesth. 2005 Mar;94(3):336-40. doi: 10.1093/bja/aei047. Epub 2004 Dec 10.

  PMID: 15591328 BACKGROUND

• Sengupta S, Ghosh S, Rudra A, Kumar P, Maitra G, Das T. Effect of ketamine on bispectral index during propofol--fentanyl anesthesia: a randomized controlled study. Middle East J Anaesthesiol. 2011 Oct;21(3):391-5.

  PMID: 22428494 BACKGROUND

• Alkire MT. Quantitative EEG correlations with brain glucose metabolic rate during anesthesia in volunteers. Anesthesiology. 1998 Aug;89(2):323-33. doi: 10.1097/00000542-199808000-00007.

  PMID: 9710389 BACKGROUND

• Werner P, Heinik J, Mendel A, Reicher B, Bleich A. Examining the reliability and validity of the Hebrew version of the Mini Mental State Examination. Aging (Milano). 1999 Oct;11(5):329-34. doi: 10.1007/BF03339808.

  PMID: 10631883 BACKGROUND

• Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, Morley JE, Chumlea W, Salva A, Rubenstein LZ, Garry P. Overview of the MNA--Its history and challenges. J Nutr Health Aging. 2006 Nov-Dec;10(6):456-63; discussion 463-5.

  PMID: 17183418 BACKGROUND

• Perna S, Francis MD, Bologna C, Moncaglieri F, Riva A, Morazzoni P, Allegrini P, Isu A, Vigo B, Guerriero F, Rondanelli M. Performance of Edmonton Frail Scale on frailty assessment: its association with multi-dimensional geriatric conditions assessed with specific screening tools. BMC Geriatr. 2017 Jan 4;17(1):2. doi: 10.1186/s12877-016-0382-3.

  PMID: 28049443 BACKGROUND

• Anderson O, Davis R, Hanna GB, Vincent CA. Surgical adverse events: a systematic review. Am J Surg. 2013 Aug;206(2):253-62. doi: 10.1016/j.amjsurg.2012.11.009. Epub 2013 May 1.

  PMID: 23642651 BACKGROUND

Results Point of Contact

• Title: Ami Stuart
• Organization: Medtronic

ami.stuart@medtronic.com

8017934800

Study Officials

• Albert Dahan, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: February 21, 2021
• Study Start: August 18, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); NL (1)