Clinical trial NCT04765046: The Influence of Age on EEG Signals and Consciousness During Anesthesia
Official title: The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Bispectral index
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

A potential subject may be included for participation in the study if the subject has/is:

1. ≥18 years of age
2. American Society of Anesthesiologists (ASA) physical status I-III
3. Able and willing to participate in the study and sign the informed consent form
4. Will undergo non-ambulatory elective surgery under general anesthesia
5. Has an expected surgery time \>2 hours

Exclusion Criteria:

A potential subject will be excluded from participating in the study if the subject has/is:

1. Pregnant
2. Unwilling to undergo EEG measurement
3. Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
4. 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.
5. Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring)
6. Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression
7. Severe visual or auditory disorder
8. Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment

Primary outcomes:
measure: BIS50
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Albert Dahan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanonidou Z, Karystianou G. Anesthesia for the elderly. Hippokratia. 2007 Oct;11(4):175-7.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.