General AnesthesiaNCT01091350
Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness
A study of General Anesthesia, run by Seoul National University Hospital.
Trial summary
The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- General Anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Nov 2009
- Phase
- Interventional
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients undergoing general anesthesia
Who cannot join
- Hepatic or renal disease
- Drug addiction
About this study
Official title: Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness
The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.
- Conditions
- General Anesthesia
- Being tested
- Diprifusor (Target-controlled infusion), Orchestra (Target-controlled infusion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diprifusor (Target-controlled infusion)Device
Also called Diprifusor(Grasby Medical Limited, United Kingdom)
Two TCI devices with different Teo and same Marsh PK model
Orchestra (Target-controlled infusion)Device
Also called OrchestraTM (Fresenius Vial, Brezins, France)
Two TCI devices with different Teo and same Marsh PK model
| Study group | Role | What they receive |
|---|---|---|
| Diprifusor group | Active comparator | Propofol was infused via Diprifusor TCI (Target-controlled infusion) Receives: Device: Diprifusor (Target-controlled infusion) |
| Orchestra group | Experimental | Propofol was infused via Orchestra TCI Receives: Device: Orchestra (Target-controlled infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated effect-site propofol concentration at loss of consciousness
Measured: after propofol infusion
Secondary outcomes (1)
Time to loss of consciousness
Measured: after propofol infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Hwang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091350
- Sponsor's protocol ID
- Orchestra vs Diprifusor
- Status last verified
- May 2013
- First submitted
- 14 Mar 2010
- Last updated
- 31 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness
- ClinicalTrials.gov ID
- NCT01091350
- Acronym / sponsor ID
- Orchestra vs Diprifusor
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Mar 2010 (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.
The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diprifusor group | Active comparator | Device: Diprifusor (Target-controlled infusion)Propofol was infused via Diprifusor TCI (Target-controlled infusion) |
| Orchestra group | Experimental | Device: Orchestra (Target-controlled infusion)Propofol was infused via Orchestra TCI |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients undergoing general anesthesia
Key exclusion criteria (2 listed)
- Hepatic or renal disease
- Drug addiction
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 |
|---|---|---|
| Diprifusor (Target-controlled infusion)Also: Diprifusor(Grasby Medical Limited, United Kingdom)Two TCI devices with different Teo and same Marsh PK model | Device | Diprifusor group |
| Orchestra (Target-controlled infusion)Also: OrchestraTM (Fresenius Vial, Brezins, France)Two TCI devices with different Teo and same Marsh PK model | Device | Orchestra group |
Primary outcome
Estimated effect-site propofol concentration at loss of consciousness
Time frame: after propofol infusion
1 secondary outcome
Time to loss of consciousness
Time frame: after propofol infusion
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 31 May 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study of General Anesthesia, run by Seoul National University Hospital.
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 2 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Estimated effect-site propofol concentration at loss of consciousness (time frame: after propofol infusion). 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 31 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.