Congenital Heart DiseaseNCT01501786
Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions
A study testing Ket10 and Ket20 in people with Congenital Heart Disease and Sedated for Cardiac Catheterization, run by Ibaraki Children's Hospital at 1 site in Japan.
Trial summary
Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Congenital Heart Disease, Sedated for Cardiac Catheterization
- What is being tested?
- Ket10 and Ket20
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to May 2013
- 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization
Who cannot join
- patients who have neurological disease,
- endocrinological disease,
- airway anomaly, who require positive pressure ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.
- Being tested
- control, Ket10, Ket20
- Keywords
- children, sedation, propofol, ketamine
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlDrug
Also called saline with propofol
propofol 8mg/kg/h saline 0.24 ml/kg/h
Ket10Drug
Also called ketamine 10 γ
propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
Ket20Drug
Also called ketamine 20 γ
propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | propofol and saline are administered Receives: Drug: control |
| Ket10 | Experimental | ketamine is co-administered with propofol Receives: Drug: Ket10 |
| Ket20 | Experimental | ketamine is co-administered with porpofol Receives: Drug: Ket20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of end tidal partial pressure of carbon dioxide between the groups
Measured: 30 and 60 min after anesthetic induction
difference of partial pressure of arterial carbon dioxide between the groups
Measured: 60 min after anesthetic induction on average
heart rate change from baseline value
Measured: 30 and 60 min after anesthetic induction
non-invasive blood pressure change from baseline value
Measured: 30 and 60 min after anesthetic induction
Secondary outcomes (2)
movement at topical anesthetic injection
- none (no movement or slight movement unnecessary to restrain)
- mild (movement necessary to restrain, limited to lower extremities)
- moderate (strong movement of lower extremities and movement of upper extremities unvecessary to restrain)
- severe (movement necessary to restrain upper extremities and body trunk in addition to lower extremities, or some vacalization)
Measured: 20 min after anesthetic induction on average
the number of times that secreted saliva is aspirated by an attending anesthesiologist
Measured: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibaraki Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuhiko Okuyama, MD, Ibaraki Children's Hospital
- Investigators
- Kazuhiko Okuyama, MD, Study chair, Ibaraki Children's HospitalYuki Takeda, MD, Principal investigator, Ibaraki Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501786
- Sponsor's protocol ID
- ketamine in sedation
- Status last verified
- Jul 2013
- First submitted
- 10 Dec 2011
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT01501786
- Acronym / sponsor ID
- ketamine in sedation
- Keywords
- children, sedation, propofol, ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ibaraki Children's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Dec 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.
Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Drug: controlpropofol and saline are administered |
| Ket10 | Experimental | Drug: Ket10ketamine is co-administered with propofol |
| Ket20 | Experimental | Drug: Ket20ketamine is co-administered with porpofol |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization
Key exclusion criteria (3 listed)
- patients who have neurological disease,
- endocrinological disease,
- airway anomaly, who require positive pressure ventilation
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 |
|---|---|---|
| controlAlso: saline with propofolpropofol 8mg/kg/h saline 0.24 ml/kg/h | Drug | control |
| Ket10Also: ketamine 10 γpropofol 6.4 mg/kg/h ketamine 10 microg/kg/min | Drug | Ket10 |
| Ket20Also: ketamine 20 γpropofol 4.8 mg/kg/h ketamine 20 microg/kg/min | Drug | Ket20 |
Primary outcome
difference of end tidal partial pressure of carbon dioxide between the groups
Time frame: 30 and 60 min after anesthetic induction
difference of partial pressure of arterial carbon dioxide between the groups
Time frame: 60 min after anesthetic induction on average
heart rate change from baseline value
Time frame: 30 and 60 min after anesthetic induction
non-invasive blood pressure change from baseline value
Time frame: 30 and 60 min after anesthetic induction
2 secondary outcomes
movement at topical anesthetic injection
Time frame: 20 min after anesthetic induction on average
the number of times that secreted saliva is aspirated by an attending anesthesiologist
Time frame: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction
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 30 Jul 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.
Kazuhiko Okuyama, MD study chair
Ibaraki Children's Hospital
Yuki Takeda, MD principal investigator
Ibaraki Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ket10 and Ket20 in people with Congenital Heart Disease and Sedated for Cardiac Catheterization, run by Ibaraki Children's Hospital at 1 site in Japan.
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: finished, as of the sponsor's last update on 30 Jul 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 Japan. 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. Some participants in this study may receive a placebo. 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?
difference of end tidal partial pressure of carbon dioxide between the groups (time frame: 30 and 60 min after anesthetic induction). The study lists 4 primary outcomes in all. 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 30 Jul 2013.