Intubating ConditionPhase 4NCT02655380
Remifentanil Requirement for Acceptable Intubating Condition
A Phase 4 study testing Ketamine 1, Ketamine 2 and Remifentanil in people with Intubating Condition, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Intubating Condition
- What is being tested?
- Ketamine 1, Ketamine 2 and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2017to 16 Apr 2018
- Phase
- Phase 4
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II
- Undergoing general anesthesia with endotracheal tube
Who cannot join
- Anticipated difficult airway
- Patient with upper respiratory infection within 14 days
- Asthma
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou universitiy school of medicine
Suwon, Gyeong-gi Do, 16499
About this study
Official title: Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children
Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.
- Conditions
- Intubating Condition
- Being tested
- Ketamine 1, Ketamine 2, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 1Drug
Anesthesia induction is performed with 1 mg ketamine.
Ketamine 2Drug
Anesthesia induction is performed with 2 mg ketamine.
RemifentanilDrug
After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.
| Study group | Role | What they receive |
|---|---|---|
| ketamine 1 | Experimental | Anesthesia induction with ketamine 1 mg followed by remifentanil. Receives: Drug: Ketamine 1; Drug: Remifentanil |
| ketamine 2 | Experimental | Anesthesia induction with ketamine 2 mg followed by remifentanil. Receives: Drug: Ketamine 2; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of intubation condition
For assessment of intubation condition, 5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. Good and excellent will be considered to be acceptable intubating condition. Poor will be reported as unacceptable intubating condition.
- Laryngoscope easiness
- Vocal cord position
- Vocal cord movement
- Movement of limb
- Coughing
Measured: during and after intubation, about 2 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start19 Jun 2017
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubating ConditionStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
- Investigators
- yun jeong chae, Ph.D, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655380
- Sponsor's protocol ID
- MED-DRU-15-354
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children
- ClinicalTrials.gov ID
- NCT02655380
- Acronym / sponsor ID
- MED-DRU-15-354
- Conditions
- Intubating Condition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 14 Jan 2016 (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.
Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine 1 | Experimental | Drug: Ketamine 1, Drug: RemifentanilAnesthesia induction with ketamine 1 mg followed by remifentanil. |
| ketamine 2 | Experimental | Drug: Ketamine 2, Drug: RemifentanilAnesthesia induction with ketamine 2 mg followed by remifentanil. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I-II
- Undergoing general anesthesia with endotracheal tube
Key exclusion criteria (3 listed)
- Anticipated difficult airway
- Patient with upper respiratory infection within 14 days
- Asthma
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 |
|---|---|---|
| Ketamine 1Anesthesia induction is performed with 1 mg ketamine. | Drug | ketamine 1 |
| Ketamine 2Anesthesia induction is performed with 2 mg ketamine. | Drug | ketamine 2 |
| RemifentanilAfter anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered. | Drug | ketamine 1, ketamine 2 |
Primary outcome
acceptability of intubation condition
Time frame: during and after intubation, about 2 minute
For assessment of intubation condition, 5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. Good and excellent will be considered to be acceptable intubating condition. Poor will be reported as unacceptable intubating condition. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing
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 10 Jan 2019.
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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.
yun jeong chae, Ph.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 Phase 4 study testing Ketamine 1, Ketamine 2 and Remifentanil in people with Intubating Condition, 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 2 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: finished, as of the sponsor's last update on 10 Jan 2019. 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?
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?
acceptability of intubation condition (time frame: during and after intubation, about 2 minute). 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 10 Jan 2019.