AnesthesiaPhase 4NCT01003028
Reduction of Remifentanil-related Complications
A Phase 4 study of Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2024to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 year old
- ASA class 1-3 scheduled for elective surgery
Who cannot join
- history of neurologic or mental disorder
- uncontrolled pulmonary or cardiovascular disease
- history of adverse reactions to opioids
- history of drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 110-744
Chul-Woo Jung, MD PhD, spss@dreamwiz.com
Chul Woo Jung, MD PhD
About this study
Official title: Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion
This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.
- Conditions
- Anesthesia
- Being tested
- Remifentanil (Limited) - Target Controlled Infusion system, Remifentanil (Control) - Target Controlled Infusion system
- Keywords
- Total intravenous anesthesia, Maximum plasma concentration of remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil (Limited) - Target Controlled Infusion systemDrug
Limit max plasma concentration to 9.8 ng/ml
Remifentanil (Control) - Target Controlled Infusion systemDrug
Use 20 ng/ml as max plasma concentration
| Study group | Role | What they receive |
|---|---|---|
| Limited | Experimental | Limit the maximum plasma concentration target to 9.8 ng/ml Receives: Drug: Remifentanil (Limited) - Target Controlled Infusion system |
| Control | Active comparator | Use 20 ng/ml as max plasma concentration Receives: Drug: Remifentanil (Control) - Target Controlled Infusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotension more than 25% from baseline
Measured: during remifentanil loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study start1 Nov 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003028
- Sponsor's protocol ID
- CW Jung_TCI_Remi_Cpmax
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2009
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion
- ClinicalTrials.gov ID
- NCT01003028
- Acronym / sponsor ID
- CW Jung_TCI_Remi_Cpmax
- Conditions
- Anesthesia
- Keywords
- Total intravenous anesthesia, Maximum plasma concentration of remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Oct 2009 (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.
This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited | Experimental | Drug: Remifentanil (Limited) - Target Controlled Infusion systemLimit the maximum plasma concentration target to 9.8 ng/ml |
| Control | Active comparator | Drug: Remifentanil (Control) - Target Controlled Infusion systemUse 20 ng/ml as max plasma concentration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 year old
- ASA class 1-3 scheduled for elective surgery
Key exclusion criteria (4 listed)
- history of neurologic or mental disorder
- uncontrolled pulmonary or cardiovascular disease
- history of adverse reactions to opioids
- history of drug abuse
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 |
|---|---|---|
| Remifentanil (Limited) - Target Controlled Infusion systemLimit max plasma concentration to 9.8 ng/ml | Drug | Limited |
| Remifentanil (Control) - Target Controlled Infusion systemUse 20 ng/ml as max plasma concentration | Drug | Control |
Primary outcome
hypotension more than 25% from baseline
Time frame: during remifentanil loading
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Anesthesia, run by Seoul National University Hospital 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Dec 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho Geol Ryu, MD, PhD (82-17-259-9173, hogeol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypotension more than 25% from baseline (time frame: during remifentanil loading). 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 1 Dec 2023.