NCT02585284

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

October 16, 2015

Last Update Submit

June 20, 2019

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (8)

vicenarian

20 to 29 years. Five males and five females

tricenarian

30 to 39 years. Five males and five females

quadragenarian

40 to 49 years. Five males and five females

quinquagenarian

50 to 59 years. Five males and five females

sexagenarian

60 to 69 years. Five males and five females

septuagenarian

70 to 79 years. Five males and five females

octogenarian

80 to 89 years. Five males and five females

nonagenarian

90-99 years. Five males and five females

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashraf Dahaba

Xi'an, China

Location

Related Publications (5)

  • 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. doi: 10.1111/j.1399-6576.2004.00258.x.

    PMID: 14674970BACKGROUND

  • Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-773. doi: 10.1213/01.ane.0000167269.62966.af.

    PMID: 16115989BACKGROUND

  • 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. doi: 10.1136/gut.2007.129130. Epub 2007 Aug 14.

    PMID: 17698861BACKGROUND

  • 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. doi: 10.1097/00000542-199906000-00003.

    PMID: 10360845BACKGROUND

  • Dahaba AA, Xiao Z, Zhu X, Dong H, Xiong L, Rehak P, Zelzer S, Wang K, Reibnegger G. Age progression from vicenarians (20-29 year) to nonagenarians (90-99 year) among a population pharmacokinetic/pharmacodynamic (PopPk-PD) covariate analysis of propofol-bispectral index (BIS) electroencephalography. J Pharmacokinet Pharmacodyn. 2020 Apr;47(2):145-161. doi: 10.1007/s10928-020-09678-0. Epub 2020 Feb 25.

    PMID: 32100175DERIVED

Study Officials

  • Zhaoyang Xiao

    Guest Professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 23, 2015

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

CN(1)