Heart Rate LowNCT03132688
A Study on Safety and Efficacy of Propofol in Small Children Under 2 Years of Age
An observational study of Heart Rate Low and Anesthesia; Functional, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Low, Anesthesia; Functional
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2017to 22 Apr 2017
- Phase
- Observational
- 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 Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who underwent surgery From September 2013 to December 2016 , and received intravenous propofol for general anesthesia will be enrolled.
Who may be able to join
- Children under 2 years of age
- Children who received intravenous propofol for maintenance of anesthesia
Who cannot join
- Children who underwent general anesthesia with inhalational anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study on Safety and Efficacy of Propofol in Small Children
This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.
Read the detailed description
EMR review of intravenous propofol used in target controlled infusion method in children under 2 years old.
- Conditions
- Heart Rate Low, Anesthesia; Functional
- Being tested
- Propofol
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Intravenous administration with dose of 100-200mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| children < 2 years old | Children under 2 years of age who received intravenous propofol during general anesthesia. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: blood pressure
blood pressure
Measured: Intraoperative 1 day
Safety: blood pressure
blood pressure
Measured: Intraoperative 7th days
Secondary outcomes (1)
Bispectral index
optimal surgical condition
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start20 Apr 2017
- Primary completion22 Apr 2017
- Study completion22 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate LowStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132688
- Sponsor's protocol ID
- H1612-136-821
- Status last verified
- Apr 2017
- First submitted
- 21 Feb 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Safety and Efficacy of Propofol in Small Children
- ClinicalTrials.gov ID
- NCT03132688
- Acronym / sponsor ID
- H1612-136-821
- Conditions
- Heart Rate Low, Anesthesia; Functional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 22 Apr 2017 (actual)
- Study completion
- 22 Apr 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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 retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.
Detailed description
EMR review of intravenous propofol used in target controlled infusion method in children under 2 years old.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children < 2 years old | – | Drug: PropofolChildren under 2 years of age who received intravenous propofol during general anesthesia. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who underwent surgery From September 2013 to December 2016 , and received intravenous propofol for general anesthesia will be enrolled.
Key inclusion criteria (2 listed)
- Children under 2 years of age
- Children who received intravenous propofol for maintenance of anesthesia
Key exclusion criteria (1 listed)
- Children who underwent general anesthesia with inhalational anesthetics
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 |
|---|---|---|
| PropofolIntravenous administration with dose of 100-200mcg/kg/min | Drug | children < 2 years old |
Primary outcome
Safety: blood pressure
Time frame: Intraoperative 1 day
blood pressure
Safety: blood pressure
Time frame: Intraoperative 7th days
blood pressure
1 secondary outcome
Bispectral index
Time frame: Intraoperative
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 28 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hee-Soo Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Low and Anesthesia; Functional, 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 1 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 28 Apr 2017. 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?
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?
Safety: blood pressure (time frame: Intraoperative 1 day). The study lists 2 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 28 Apr 2017.