Inguinal HerniaPhase 4NCT02646709
The Effect of Different Dose of Ketamine With Low Dose Rocuronium in Children
A Phase 4 study testing Rocuronium, ketamine 1 and ketamine 1.5 in people with Inguinal Hernia, run by Ajou University School of Medicine.
Trial summary
Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Rocuronium, ketamine 1 and ketamine 1.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA class I, II
Who cannot join
- upper respiratory infection within 14 days
- anticipated difficult intubation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Different Doses of Ketamine on Tracheal Intubating Conditions Using Low Dose Rocuronium in Children
Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.
- Conditions
- Inguinal Hernia
- Being tested
- Rocuronium, ketamine 1, ketamine 1.5, ketamine 2
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.
ketamine 1Drug
ketamine 1 mg/kg will be injected for induction of anesthesia
ketamine 1.5Drug
ketamine 1.5 mg/kg will be injected for induction of anesthesia
ketamine 2Drug
ketamine 2 mg/kg will be injected for induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ketamine 1 | Experimental | Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. Receives: Drug: Rocuronium; Drug: ketamine 1 |
| Ketamine 1.5 | Experimental | Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. Receives: Drug: Rocuronium; Drug: ketamine 1.5 |
| Ketamine 2 | Experimental | Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. Receives: Drug: Rocuronium; Drug: ketamine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Laryngoscope easiness
- Vocal cord position
- Vocal cord movement
- Movement of limb
- Coughing
Measured: during and after intubation, about 2 minute
Secondary outcomes (9)
heart rate
heart rate will be recorded.
Measured: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation
time for extubation
Measured: from the end of surgery to extubation, within 10 min
emergence agitation (4 points scale)
4 points scale
1: calm 2. cry but manageable 3. cry, not manageable 4. excitation
Measured: 5 min after postanesthesia care unit (PACU) admission
PACU time
Measured: from PACU admission to discharge, about 30 min
severity of vomiting
severity(0-10)
Measured: 1. 1 min after PACU admission 2. 30 min after PACU admission
Analgesic requirements (mg/kg)
if pain score exceed 3, fentanyl will be introduced. The total dose of fentanyl injection will be recorded.
Measured: during PACU stay, about 30 min
Desaturation
pulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded.
Measured: during PACU stay, about 30 min
blood pressure
blood pressure will be recorded
Measured: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation
frequency of vomiting
Measured: 1. 1 min after PACU admission 2. 30 min after PACU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Go Un Roh, Ajou University School of Medicine
- Investigators
- Go Un Roh, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646709
- Sponsor's protocol ID
- AJIRB-MED-CT4-15-153
- Status last verified
- Jan 2016
- First submitted
- 28 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Ketamine on Tracheal Intubating Conditions Using Low Dose Rocuronium in Children
- ClinicalTrials.gov ID
- NCT02646709
- Acronym / sponsor ID
- AJIRB-MED-CT4-15-153
- Conditions
- Inguinal Hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 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.
Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine 1 | Experimental | Drug: Rocuronium, Drug: ketamine 1Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. |
| Ketamine 1.5 | Experimental | Drug: Rocuronium, Drug: ketamine 1.5Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. |
| Ketamine 2 | Experimental | Drug: Rocuronium, Drug: ketamine 2Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA class I, II
Key exclusion criteria (2 listed)
- upper respiratory infection within 14 days
- anticipated difficult intubation
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 |
|---|---|---|
| RocuroniumLow dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine. | Drug | Ketamine 1, Ketamine 1.5, Ketamine 2 |
| ketamine 1ketamine 1 mg/kg will be injected for induction of anesthesia | Drug | Ketamine 1 |
| ketamine 1.5ketamine 1.5 mg/kg will be injected for induction of anesthesia | Drug | Ketamine 1.5 |
| ketamine 2ketamine 2 mg/kg will be injected for induction of anesthesia | Drug | Ketamine 2 |
Primary outcome
Intubation Condition
Time frame: during and after intubation, about 2 minute
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. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing
9 secondary outcomes
heart rate
Time frame: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation
time for extubation
Time frame: from the end of surgery to extubation, within 10 min
emergence agitation (4 points scale)
Time frame: 5 min after postanesthesia care unit (PACU) admission
PACU time
Time frame: from PACU admission to discharge, about 30 min
severity of vomiting
Time frame: 1. 1 min after PACU admission 2. 30 min after PACU admission
Analgesic requirements (mg/kg)
Time frame: during PACU stay, about 30 min
Desaturation
Time frame: during PACU stay, about 30 min
blood pressure
Time frame: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation
frequency of vomiting
Time frame: 1. 1 min after PACU admission 2. 30 min after PACU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Go Un Roh, MD principal investigator
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium, ketamine 1 and ketamine 1.5 in people with Inguinal Hernia, run by Ajou University School of Medicine.
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: status not confirmed, as of the sponsor's last update on 6 Jan 2016. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Go Un Roh, MD (82-31-219-6435, gone7968@aumc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 6 Jan 2016.