Propofol Overdose of Undetermined IntentTCIGeriatricNCT01435785
Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients
An observational study of Propofol Overdose of Undetermined Intent, run by Universidad del Desarrollo at 2 sites in Chile.
Trial summary
Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Propofol Overdose of Undetermined Intent
- How many people
- 14 participants
- Where
- 2 sitesChile
- Study dates
- Apr 2011to Dec 2011
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients older than 65 years, ASA 1,2 programed for elective sugery
Who may be able to join
- Patients older than 65 years, ASA 1,2
Who cannot join
- Included less than 70% or more than 130% of ideal body weight
- Neurologic disorder
- Use of psychoactive medication, including alcohol intake during the last 48 hours
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Clinica Alemana de Santiago
Santiago, 76534
Clinica Alemana Santiago
Santiago, 76534
About this study
Official title: Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients
Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.
Read the detailed description
After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.
- Conditions
- Propofol Overdose of Undetermined Intent
- Keywords
- PKPD, Propofol, TCI, Elderly patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Overdose of Undetermined IntentStudies of the same condition, open and under way.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile
- Responsible party
- Principal investigator, Pablo O. Sepulveda, Universidad del Desarrollo
- Investigators
- Pablo O Sepulveda, MD, Principal investigator, Clinica Alemana Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435785
- Sponsor's protocol ID
- Propofol TCI in Geriatric
- Acronym
- TCIGeriatric
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2011
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open TCI proyect
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients
- ClinicalTrials.gov ID
- NCT01435785
- Acronym / sponsor ID
- TCIGeriatric / Propofol TCI in Geriatric
- Conditions
- Propofol Overdose of Undetermined Intent
- Keywords
- PKPD, Propofol, TCI, Elderly patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile
- Study start
- Apr 2011 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Sep 2011 (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.
Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.
Detailed description
After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients older than 65 years, ASA 1,2 programed for elective sugery
Key inclusion criteria (1 listed)
- Patients older than 65 years, ASA 1,2
Key exclusion criteria (3 listed)
- Included less than 70% or more than 130% of ideal body weight
- Neurologic disorder
- Use of psychoactive medication, including alcohol intake during the last 48 hours
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
Not reported in the source record.
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 29 Mar 2017.
- Individual participant dataSharing planned: Yes. Open TCI proyect
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.
Pablo O Sepulveda, MD principal investigator
Clinica Alemana Universidad del Desarrollo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Propofol Overdose of Undetermined Intent, run by Universidad del Desarrollo at 2 sites in Chile.
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 3 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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.
Where can I read the original study information?
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 29 Mar 2017.