The Influence of Age on EEG Signals and Consciousness During Anesthesia

Anesthesia Clinical Trial

— TIARA  

Official title:

The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765046
• Other study ID #: MDT18067TIARA
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: April 3, 2023

Study information

• Verified date: July 2023
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Bispectral (BIS™) Complete Monitoring System
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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

Israel,  Netherlands, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS Parameter	To determine the relationship between the BIS number, age, depth of anesthesia	8 hours