AnesthesiaNCT03195530
Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol
An observational study of Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
A correlation between the bispectral index values and electroencephalographic patterns at the loss of consciousness (LOC) when using propofol in elderly patients, has not been determined. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol
- How many people
- 12 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2017to 31 Mar 2018
- 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
- No healthy volunteers
- Older adult
Study population: Elderly patients scheduled for surgery are an understudied population. Incidence of postoperative delirium and other complications can be related to changes in cerebral dynamics under anesthesia, with effects observed even after the use of anesthetics agents. To characterize changes in EEG patterns under the induction of anesthesia, can give new information to understand the physiology of the elderly brain under anesthesia.
Who may be able to join
- Patients over 65 years
- Scheduled for elective surgery requiring general anesthesia
- American Society of Anesthesiology (ASA) Score I or II
Who cannot join
- Patients with neurological diseases
- Requiring the use of two or more drugs affecting Central nervous system
- History of drugs or alcohol abuse
- Body mass index over 35 kg/m^2
- Propofol allergy
- Cardiac congestive failure
- History of coronary syndrome
- Minimental test altered (Score under 24 points)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Division de Anestesia - Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
About this study
Official title: Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol, According to the Characteristic Electroencephalographic Pattern
A correlation between the bispectral index values and electroencephalographic patterns at the loss of consciousness (LOC) when using propofol in elderly patients, has not been determined.
Our aim is to describe the BIS values and the power of the alpha band in the electroencephalography in elderly patients, at the LOC moment.
Read the detailed description
Propofol is an anesthetic drug regularly used in elderly patients requiring anesthesia. The electroencephalographic pattern recognized when propofol is administered, is different to the pattern obtained in younger patients. Both groups presents an alpha and slow bands, but they differ in the intensity of the signal. Younger patients presents more intense electroencephalographic bands than older patients.
Bispectral index (BIS) is a clinical indicator used to evaluate the depth of anesthesia. A correlation between this indicator and the power of electroencephalographic bands has not been determined.
We will describe the LOC moment of elderly patients receiving propofol as anesthetic for general surgery, with the EEG characteristic bands and the BIS value obtained at that moment. The BIS values related to the EEG characteristic bands can be described, to correlate the actual indicators of depth of anesthesia with new parameters.
- Conditions
- Anesthesia
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Patients over 65 years, scheduled to general surgery, requiring general anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS values at which EEG patterns (Slow and alpha bands) appears in elderly population using propofol
To describe the BIS values correlated to specific EEG patterns
Measured: Induction of anesthesia
Secondary outcomes (1)
Propofol concentration required to observe specific EEG patterns
To describe the serum propofol concentrations required for induction of anesthesia, to observe alpha and slow bands at the EEG.
Measured: Induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 May 2017
- Primary completion31 Jan 2018
- Study completion31 Mar 2018
Why it stopped: Out of funding, no differences between groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195530
- Sponsor's protocol ID
- 161207002
- Status last verified
- Apr 2018
- First submitted
- 20 Jun 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol, According to the Characteristic Electroencephalographic Pattern
- ClinicalTrials.gov ID
- NCT03195530
- Acronym / sponsor ID
- 161207002
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Out of funding, no differences between groups
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- 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.
A correlation between the bispectral index values and electroencephalographic patterns at the loss of consciousness (LOC) when using propofol in elderly patients, has not been determined.
Our aim is to describe the BIS values and the power of the alpha band in the electroencephalography in elderly patients, at the LOC moment.
Detailed description
Propofol is an anesthetic drug regularly used in elderly patients requiring anesthesia. The electroencephalographic pattern recognized when propofol is administered, is different to the pattern obtained in younger patients. Both groups presents an alpha and slow bands, but they differ in the intensity of the signal. Younger patients presents more intense electroencephalographic bands than older patients.
Bispectral index (BIS) is a clinical indicator used to evaluate the depth of anesthesia. A correlation between this indicator and the power of electroencephalographic bands has not been determined.
We will describe the LOC moment of elderly patients receiving propofol as anesthetic for general surgery, with the EEG characteristic bands and the BIS value obtained at that moment. The BIS values related to the EEG characteristic bands can be described, to correlate the actual indicators of depth of anesthesia with new parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | Drug: PropofolPatients over 65 years, scheduled to general surgery, requiring general anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients scheduled for surgery are an understudied population. Incidence of postoperative delirium and other complications can be related to changes in cerebral dynamics under anesthesia, with effects observed even after the use of anesthetics agents. To characterize changes in EEG patterns under the induction of anesthesia, can give new information to understand the physiology of the elderly brain under anesthesia.
Key inclusion criteria (3 listed)
- Patients over 65 years
- Scheduled for elective surgery requiring general anesthesia
- American Society of Anesthesiology (ASA) Score I or II
Key exclusion criteria (8 listed)
- Patients with neurological diseases
- Requiring the use of two or more drugs affecting Central nervous system
- History of drugs or alcohol abuse
- Body mass index over 35 kg/m^2
- Propofol allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolInduction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction | Drug | Elderly patients |
Primary outcome
BIS values at which EEG patterns (Slow and alpha bands) appears in elderly population using propofol
Time frame: Induction of anesthesia
To describe the BIS values correlated to specific EEG patterns
1 secondary outcome
Propofol concentration required to observe specific EEG patterns
Time frame: Induction of anesthesia
Results and safety
The study was stopped early (reason given: Out of funding, no differences between groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Apr 2018. 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 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 was stopped early (reason given: Out of funding, no differences between groups). Results are not available in the source record.
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?
BIS values at which EEG patterns (Slow and alpha bands) appears in elderly population using propofol (time frame: Induction of anesthesia). It is what the study was designed to measure, not a finding.
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 11 Apr 2018.