Intravenous Drug UsageNCT01477905
Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil
A study testing Remi50 with prime and Remi20 with prime in people with Intravenous Drug Usage, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intravenous Drug Usage
- What is being tested?
- Remi50 with prime and Remi20 with prime
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Apr 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- electric medical records of the patients who had undergone general anaesthesia
Who cannot join
- body weight exceeding 20% of ideal body weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe
The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.
Read the detailed description
Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.
- Conditions
- Intravenous Drug Usage
- Being tested
- Remi50 with prime, Remi20 with prime
- Keywords
- priming, remifentanil, target-controlled infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remi50 with primeDevice
Also called remi50 prime
for using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING
Remi20 with primeDevice
Also called remi20 prime
For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING
| Study group | Role | What they receive |
|---|---|---|
| Remi50 no prime | Experimental | For using experimental target control infusion device (TCIs), targeting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) of remifentanil, and without PRIMING, Receives: Device: Remi50 with prime |
| Remi20 no prmie | Experimental | For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and without PRIMING Receives: Device: Remi20 with prime |
What is being measured
The primary outcome is the main question the study is designed to answer.
delivered infusates of remifentanil
For targetting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) or 20 μg/ml (Remi20) of remifentanil, and with or without PRIMING, TCI data files, including predicted plasma (Cp-proper), and effect-site (Ceff-proper) concentrations were saved
Measured: base line from 30 min of TCI was maintained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Drug UsageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, M.D., Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477905
- Sponsor's protocol ID
- AJIRB-DEV-DEO-11-005
- Status last verified
- Nov 2011
- First submitted
- 14 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Swinhoe CF, Peacock JE, Glen JB, Reilly CS. Evaluation of the predictive performance of a 'Diprifusor' TCI system. Anaesthesia. 1998 Apr;53 Suppl 1:61-7. doi: 10.1111/j.1365-2044.1998.53s104.x.
PubMed 9640119
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe
- ClinicalTrials.gov ID
- NCT01477905
- Acronym / sponsor ID
- AJIRB-DEV-DEO-11-005
- Conditions
- Intravenous Drug Usage
- Keywords
- priming, remifentanil, target-controlled infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Nov 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.
The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.
Detailed description
Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remi50 no prime | Experimental | Device: Remi50 with primeFor using experimental target control infusion device (TCIs), targeting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) of remifentanil, and without PRIMING, |
| Remi20 no prmie | Experimental | Device: Remi20 with primeFor using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and without PRIMING |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- electric medical records of the patients who had undergone general anaesthesia
Key exclusion criteria (1 listed)
- body weight exceeding 20% of ideal body weight
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 |
|---|---|---|
| Remi50 with primeAlso: remi50 primefor using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING | Device | Remi50 no prime |
| Remi20 with primeAlso: remi20 primeFor using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING | Device | Remi20 no prmie |
Primary outcome
delivered infusates of remifentanil
Time frame: base line from 30 min of TCI was maintained
For targetting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) or 20 μg/ml (Remi20) of remifentanil, and with or without PRIMING, TCI data files, including predicted plasma (Cp-proper), and effect-site (Ceff-proper) concentrations were saved
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 23 Nov 2011.
- Results publication: PubMed 9640119Swinhoe CF, Peacock JE, Glen JB, Reilly CS. Evaluation of the predictive performance of a 'Diprifusor' TCI system. Anaesthesia. 1998 Apr;53 Suppl 1:61-7. doi: 10.1111/j.1365-2044.1998.53s104.x.
Related trials for Intravenous Drug Usage
RecruitingObservational study
A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
Life Threatening Bleeding, Factor Xa Inhibitor
Enrolling by invitation
JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer
Lower Urinary Tract Symptoms, Intravenous Drug Usage
Active, not recruiting
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Opioid-Related Disorders, Hepatitis C (HCV)
RecruitingObservational study
A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency
Protein C Deficiency
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.
Jong Yeop Kim, M.D. study director
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remi50 with prime and Remi20 with prime in people with Intravenous Drug Usage, run by Ajou University School of Medicine at 1 site in South Korea.
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 23 Nov 2011. 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 South Korea. 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?
delivered infusates of remifentanil (time frame: base line from 30 min of TCI was maintained). 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 NCT01477905, which also lists 1 linked publication.
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 23 Nov 2011.