Intubation, IntratrachealNCT02001285
Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation
A study testing Remifentanil in people with Intubation, Intratracheal, run by Jeju National University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is the comparison of the effect-site concentration of remifentanil for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial intubation during propofol-remifentanil total intravenous anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Sep 2015
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patient who is needed intubation for general anesthesia
Who cannot join
- patient who is anticipating difficult airway
- patient who takes any drug to influence this study
- cardiovascular disease, renal disease, liver disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jeju National University Hospital
Jeju City, Jeju Special Self-Governing Province, 690-767
Hyun Jung Kim, MD, PhD, 82-64-717-2026, hjanesthesia@empas.com
About this study
Official title: Comparison of the Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Ordinary Tracheal and Double-lumen Endobronchial Intubation During Propofol-remifentanil Total Intravenous Anesthesia
The purpose of this study is the comparison of the effect-site concentration of remifentanil for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial intubation during propofol-remifentanil total intravenous anesthesia.
- Conditions
- Intubation, Intratracheal
- Being tested
- Remifentanil
- Keywords
- remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva (TM)
During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Double lumen tube | Experimental | This arm contains patients who are needed endobronchial intubation with double lumen tube for general anesthesia. After propofol infusion of effect site concentration 4 μg/ml, remifentanil infusion will be started with effect site concentration of 3.5 ng/ml. According to change arterial blood pressure and heart rate from baseline value, next remifentanil concentration will be regulated using up-and-down method. Step size of dose is 0.5 ng/ml. Receives: Drug: Remifentanil |
| single lumen tube | Active comparator | This arm contains patients who are needed endotracheal intubation with single lumen tube for general anesthesia. After propofol infusion of effect site concentration 4 μg/ml, remifentanil infusion will be started with effect site concentration of 3.5 ng/ml. According to change arterial blood pressure and heart rate from baseline value, next remifentanil concentration will be regulated using up-and-down method. Step size of dose is 0.5 ng/ml. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood pressure
Arterial blood pressure will be recorded before anesthesia, after propofol infusion, after remifentanil infusion and after intubation during 3 min with 1 min interval.
Measured: Change from baseline in arterial blood pressure at intubation period
Secondary outcomes (1)
heart rate
Heart rate will be recorded before anesthesia, after propofol infusion, after remifentanil infusion and after intubation during 3 min with 1 min interval.
Measured: Change from baseline in heart rate at intubation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeju National University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jung Kim, Jeju National University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001285
- Sponsor's protocol ID
- HJKim2
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Ordinary Tracheal and Double-lumen Endobronchial Intubation During Propofol-remifentanil Total Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT02001285
- Acronym / sponsor ID
- HJKim2
- Conditions
- Intubation, Intratracheal
- Keywords
- remifentanil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jeju National University School of MedicineUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 4 Dec 2013 (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 purpose of this study is the comparison of the effect-site concentration of remifentanil for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial intubation during propofol-remifentanil total intravenous anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double lumen tube | Experimental | Drug: RemifentanilThis arm contains patients who are needed endobronchial intubation with double lumen tube for general anesthesia. After propofol infusion of effect site concentration 4 μg/ml, remifentanil infusion will be started with effect site concentration of 3.5 ng/ml. According to change arterial blood pressure and heart rate from baseline value, next remifentanil concentration will be regulated using up-and-down method. Step size of dose is 0.5 ng/ml. |
| single lumen tube | Active comparator | Drug: RemifentanilThis arm contains patients who are needed endotracheal intubation with single lumen tube for general anesthesia. After propofol infusion of effect site concentration 4 μg/ml, remifentanil infusion will be started with effect site concentration of 3.5 ng/ml. According to change arterial blood pressure and heart rate from baseline value, next remifentanil concentration will be regulated using up-and-down method. Step size of dose is 0.5 ng/ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patient who is needed intubation for general anesthesia
Key exclusion criteria (3 listed)
- patient who is anticipating difficult airway
- patient who takes any drug to influence this study
- cardiovascular disease, renal disease, liver disease
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 |
|---|---|---|
| RemifentanilAlso: Ultiva (TM)During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate. | Drug | Double lumen tube, single lumen tube |
Primary outcome
arterial blood pressure
Time frame: Change from baseline in arterial blood pressure at intubation period
Arterial blood pressure will be recorded before anesthesia, after propofol infusion, after remifentanil infusion and after intubation during 3 min with 1 min interval.
1 secondary outcome
heart rate
Time frame: Change from baseline in heart rate at intubation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil in people with Intubation, Intratracheal, run by Jeju National 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 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: status not confirmed, as of the sponsor's last update on 4 Dec 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jung Kim, MD, PhD (82-64-717-2026, hjanesthesia@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood pressure (time frame: Change from baseline in arterial blood pressure at intubation period). 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 4 Dec 2013.