Effect of Age on Propofol-BIS Response

Aging Clinical Trial

— BIS3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585284
• Other study ID #: MUGraz3
• Status: Completed
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2019
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Locations

Country	Name	City	State
China	Ashraf Dahaba	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

China, 

References & Publications (4)

Dahaba AA, Worm HC, Zhu SM, Bao FP, Salah A, Zakaria S, Bornemann H, Stadlbauer V, Rehak PH, Metzler H, Stauber RE. Sensitivity and specificity of bispectral index for classification of overt hepatic encephalopathy: a multicentre, observer blinded, validation study. Gut. 2008 Jan;57(1):77-83. Epub 2007 Aug 14. — View Citation

Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-73. Review. — View Citation

Schnider TW, Minto CF, Shafer SL, Gambus PL, Andresen C, Goodale DB, Youngs EJ. The influence of age on propofol pharmacodynamics. Anesthesiology. 1999 Jun;90(6):1502-16. — View Citation

Schultz A, Grouven U, Zander I, Beger FA, Siedenberg M, Schultz B. Age-related effects in the EEG during propofol anaesthesia. Acta Anaesthesiol Scand. 2004 Jan;48(1):27-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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