Ambulatory OrchipexyNCT02163980
Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics
A study testing Caudal ropivacaine + normal saline and Caudal ropivacaine + dexmedetomidine in people with Ambulatory Orchipexy, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy. Read more about this study
- Who is it for?
- Ages 1 year to 6 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ambulatory Orchipexy
- What is being tested?
- Caudal ropivacaine + normal saline and Caudal ropivacaine + dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jul 2011
- 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 1 year to 6 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- children undergoing ambulatory orchiopexy,
- ASA status I
Who cannot join
- mental retardation,
- developmental delay,
- neurological or psychiatric illness,
- coagulation disorder,
- spinal anomalies
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Univ. College of Medicine Dep. Of Anesthesiology
Seoul, Seoul, 120-752
About this study
The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.
- Conditions
- Ambulatory Orchipexy
- Being tested
- Caudal ropivacaine + normal saline, Caudal ropivacaine + dexmedetomidine
- Keywords
- dexmedetomidine, caudal block, children, children (1-6 years) undergoing ambulatory orchipexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal ropivacaine + normal salineDrug
Caudal ropivacaine + dexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Caudal ropivacaine + normal saline | Placebo comparator | 1.5ml kg-1 ropivacaine 0.15% with normal saline (Control group, n=40). Receives: Drug: Caudal ropivacaine + normal saline |
| Caudal ropivacaine + dexmedetomidine | Experimental | 1.5ml kg-1 ropivacaine 0.15% with dexmedetomidine 1 μg kg-1 (DEX group, n=40) Receives: Drug: Caudal ropivacaine + dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital sign
systolic arterial pressure
Measured: up to 180 min after surgery
Secondary outcomes (1)
inhalation anesthetics requirements
end-tidal sevoflurane concentration required to maintain hemodynamic changes < 20% of the preoperative baseline
Measured: up to 180 min after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ambulatory OrchipexyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163980
- Sponsor's protocol ID
- 4-2011-0111
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho JE, Kim JY, Park SJ, Kil HK. The Effect of 1 microg/kg Dexmedetomidine Combined with High-Volume/Low-Concentration Caudal Ropivacaine in Children Undergoing Ambulatory Orchiopexy. Biol Pharm Bull. 2015;38(7):1020-5. doi: 10.1248/bpb.b15-00086.
PubMed 26133711
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics
- ClinicalTrials.gov ID
- NCT02163980
- Acronym / sponsor ID
- 4-2011-0111
- Conditions
- Ambulatory Orchipexy
- Keywords
- dexmedetomidine, caudal block, children, children (1-6 years) undergoing ambulatory orchipexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Jun 2014 (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 investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal ropivacaine + normal saline | Placebo comparator | Drug: Caudal ropivacaine + normal saline1.5ml kg-1 ropivacaine 0.15% with normal saline (Control group, n=40). |
| Caudal ropivacaine + dexmedetomidine | Experimental | Drug: Caudal ropivacaine + dexmedetomidine1.5ml kg-1 ropivacaine 0.15% with dexmedetomidine 1 μg kg-1 (DEX group, n=40) |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children undergoing ambulatory orchiopexy,
- ASA status I
Key exclusion criteria (5 listed)
- mental retardation,
- developmental delay,
- neurological or psychiatric illness,
- coagulation disorder,
- spinal anomalies
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 |
|---|---|---|
| Caudal ropivacaine + normal saline | Drug | Caudal ropivacaine + normal saline |
| Caudal ropivacaine + dexmedetomidine | Drug | Caudal ropivacaine + dexmedetomidine |
Primary outcome
vital sign
Time frame: up to 180 min after surgery
systolic arterial pressure
1 secondary outcome
inhalation anesthetics requirements
Time frame: up to 180 min after surgery
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 16 Jun 2014.
- Derived from this study: PubMed 26133711Cho JE, Kim JY, Park SJ, Kil HK. The Effect of 1 microg/kg Dexmedetomidine Combined with High-Volume/Low-Concentration Caudal Ropivacaine in Children Undergoing Ambulatory Orchiopexy. Biol Pharm Bull. 2015;38(7):1020-5. doi: 10.1248/bpb.b15-00086.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal ropivacaine + normal saline and Caudal ropivacaine + dexmedetomidine in people with Ambulatory Orchipexy, run by Yonsei University 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 5 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 16 Jun 2014. 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. 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?
vital sign (time frame: up to 180 min after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163980, which also lists 1 linked publication.
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 16 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.