PediatricsNCT01147757
Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy
A study testing remifentanil in people with Pediatrics, run by Yonsei University at 1 site in South Korea.
Trial summary
Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Pediatrics
- What is being tested?
- remifentanil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Jun 2012
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy
Who cannot join
- cardiovascular, renal, liver disease or growth retardation
Trial locations and contacts
1 site in 1 country.
Jeong-Yeon Hong contact
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Jeong-Yeon Hong, M.D., 82-2-2228-2427
About this study
Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.
- Conditions
- Pediatrics
- Being tested
- remifentanil
- Keywords
- pediatric patients (ASA physical status I or II) aged between
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
During surgery, 3 different dose of remifentanil or placebo was infused.
| Study group | Role | What they receive |
|---|---|---|
| saline | Placebo comparator | Group S (n = 15): saline Receives: Drug: remifentanil |
| remifentanil 0.3 mcg/kg/min | Experimental | Group 0.3 (n = 15): remifentanil 0.3 mcg/kg/min Receives: Drug: remifentanil |
| remifentanil 0.6 mcg/kg/min | Experimental | Group 0.6 (n = 15): remifentanil 0.6 mcg/kg/min Receives: Drug: remifentanil |
| remifentanil 0.9 mcg/kg/min | Experimental | Group 0.9 (n = 15): remifentanil 0.9 mcg/kg/min Receives: Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
fentanyl consumption for IV-PCA
Measured: 24 h and 48 h after surgery
Postoperative pain score
Measured: during 48 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Yeon Hong, Yonsei University
- Investigators
- Jeong-Yeon Hong, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147757
- Sponsor's protocol ID
- 4-2010-0129
- Status last verified
- Dec 2011
- First submitted
- 17 Jun 2010
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy
- ClinicalTrials.gov ID
- NCT01147757
- Acronym / sponsor ID
- 4-2010-0129
- Conditions
- Pediatrics
- Keywords
- pediatric patients (ASA physical status I or II) aged between
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 22 Jun 2010 (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.
Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| saline | Placebo comparator | Drug: remifentanilGroup S (n = 15): saline |
| remifentanil 0.3 mcg/kg/min | Experimental | Drug: remifentanilGroup 0.3 (n = 15): remifentanil 0.3 mcg/kg/min |
| remifentanil 0.6 mcg/kg/min | Experimental | Drug: remifentanilGroup 0.6 (n = 15): remifentanil 0.6 mcg/kg/min |
| remifentanil 0.9 mcg/kg/min | Experimental | Drug: remifentanilGroup 0.9 (n = 15): remifentanil 0.9 mcg/kg/min |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy
Key exclusion criteria (1 listed)
- cardiovascular, renal, liver disease or growth retardation
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 |
|---|---|---|
| remifentanilDuring surgery, 3 different dose of remifentanil or placebo was infused. | Drug | remifentanil 0.3 mcg/kg/min, remifentanil 0.6 mcg/kg/min, remifentanil 0.9 mcg/kg/min, saline |
Primary outcome
fentanyl consumption for IV-PCA
Time frame: 24 h and 48 h after surgery
Postoperative pain score
Time frame: during 48 h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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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.
Jeong-Yeon Hong contact
Jeong-Yeon Hong principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remifentanil in people with Pediatrics, 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 1 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: status not confirmed, as of the sponsor's last update on 6 Dec 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Yeon Hong (jenyhongg@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fentanyl consumption for IV-PCA (time frame: 24 h and 48 h after surgery). 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 6 Dec 2011.