AgingBIS3NCT02585284
Effect of Age on Propofol-BIS Response
An observational study of Aging, run by Suez Canal University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aging
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)
Who may be able to join
- 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)
Who cannot join
- Patients with liver disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed 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
- Conditions
- Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Bispectral Index value-TCI response curves
Gradual Induction with propofol over 3.5 minutes from 0 to 3.5 microgram ml-1
Measured: During Induction 3.5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Dahaba, MD, Suez Canal University
- Investigators
- Zhaoyang Xiao, Study director, Guest Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585284
- Sponsor's protocol ID
- MUGraz3
- Acronym
- BIS3
- Status last verified
- Jun 2019
- First submitted
- 16 Oct 2015
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14674970Dahaba 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.
PubMed 16115989Dahaba 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.
PubMed 17698861Schnider 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.
PubMed 10360845Dahaba 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.
PubMed 32100175
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02585284
- Acronym / sponsor ID
- BIS3 / MUGraz3
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)
Key inclusion criteria (1 listed)
- 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)
Key exclusion criteria (1 listed)
- Patients with liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Bispectral Index value-TCI response curves
Time frame: During Induction 3.5 minutes
Gradual Induction with propofol over 3.5 minutes from 0 to 3.5 microgram ml-1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Background: PubMed 14674970Schultz 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.
- Background: PubMed 16115989Dahaba 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.
- Background: PubMed 17698861Dahaba 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.
- Background: PubMed 10360845Schnider 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.
- Derived from this study: PubMed 32100175Dahaba 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.
Related trials for Aging
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationObservational study
Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults
Geriatrics, Older Adults (60 - 85 Years Old)
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoyang Xiao study director
Guest Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Suez Canal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Bispectral Index value-TCI response curves (time frame: During Induction 3.5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585284, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.