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Effect of Age on Propofol-BIS Response (BIS3)

S

Suez Canal University

Status

Completed

Conditions

Aging

Study type

Observational

Funder types

Other

Identifiers

NCT02585284
MUGraz3

Details and patient eligibility

About

Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS) value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived from a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies precisely quantifying BIS response to propofol concentrations among different age groups

Full description

Objective: Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS) value of 46 before anesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS value of 52 after propofol anesthesia recovery. BIS algorithm was heuristically derived from a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies precisely quantifying BIS response to propofol concentrations among different age groups.

Methods: Investigators set Propofol estimated plasma concentrations (Cp) to gradually reach 3.5 microg·mL-1 over 3.5 min in 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr). BIS values were fitted against Cp in our newly devised logistic model and traditional sigmoid Emax model. Raw BIS electroencephalography and measured propofol arterial samples determined whether changes are pharmacodynamic or pharmacokinetic asserted.

Propofol link to FDA site at FDA's Drugs@FDA web site. https://www.accessdata.fda.gov/scripts/cder/drugsatfda: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Enrollment

80 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)

Exclusion criteria

Patients with liver disease

Trial design

80 participants in 8 patient groups

vicenarian
Description:
20 to 29 years. Five males and five females
tricenarian
Description:
30 to 39 years. Five males and five females
quadragenarian
Description:
40 to 49 years. Five males and five females
quinquagenarian
Description:
50 to 59 years. Five males and five females
sexagenarian
Description:
60 to 69 years. Five males and five females
septuagenarian
Description:
70 to 79 years. Five males and five females
octogenarian
Description:
80 to 89 years. Five males and five females
nonagenarian
Description:
90-99 years. Five males and five females

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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