Effect of Age on Propofol-BIS Response

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Effect of Age on Propofol-Bispectral Index Response Relationship Among Different Age Groups From Vicenarians to Nonagenarians. A New Logistic Model Compared With Traditional Sigmoid Emax Model

Conditions
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Aging

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vicenarian<br>20 to 29 years. Five males and five females | |
| tricenarian<br>30 to 39 years. Five males and five females | |
| quadragenarian<br>40 to 49 years. Five males and five females | |
| quinquagenarian<br>50 to 59 years. Five males and five females | |
| sexagenarian<br>60 to 69 years. Five males and five females | |
| septuagenarian<br>70 to 79 years. Five males and five females | |
| octogenarian<br>80 to 89 years. Five males and five females | |
| nonagenarian<br>90-99 years. Five males and five females | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Bispectral Index value-TCI response curves | Gradual Induction with propofol over 3.5 minutes from 0 to 3.5 microgram ml-1 | During Induction 3.5 minutes |