Healthy SubjectsNCT01175746
The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia
A study testing Nicardipine and remifentanil in people with Healthy Subjects, run by Yonsei University.
Trial summary
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Nicardipine and remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Dec 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult patients undergoing hypotensive anesthesia
Who cannot join
- patients with any co-morbidity
About this study
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.
- Conditions
- Healthy Subjects
- Being tested
- Nicardipine, remifentanil
- Keywords
- healthy adult patients, ASA class I, hypotensive anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
remifentanilDrug
Also called ultiva®
0.1-0.5 ugkg/min during hypotensive anesthesia
| Study group | Role | What they receive |
|---|---|---|
| nicardipine | Experimental | Not described Receives: Drug: Nicardipine |
| remifentanil | Active comparator | Not described Receives: Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine Clearance
Hypotensive anesthesia means that we maintain the mean blood pressure between 55 \& 65 mmHg during surgery to decrease the blood loss.
The specific time point is exactly 2hr after we star to lower the blood pressure.
Measured: 2hr after the start of hypotensive anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Young Kim, Principal investigator, Severance hospital, YUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175746
- Sponsor's protocol ID
- 3-2009-0196
- Status last verified
- Jun 2013
- First submitted
- 2 Aug 2010
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia
- ClinicalTrials.gov ID
- NCT01175746
- Acronym / sponsor ID
- 3-2009-0196
- Conditions
- Healthy Subjects
- Keywords
- healthy adult patients, ASA class I, hypotensive anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Aug 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.
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nicardipine | Experimental | Drug: Nicardipine |
| remifentanil | Active comparator | Drug: remifentanil |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adult patients undergoing hypotensive anesthesia
Key exclusion criteria (1 listed)
- patients with any co-morbidity
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 |
|---|---|---|
| Nicardipine | Drug | nicardipine |
| remifentanilAlso: ultiva®0.1-0.5 ugkg/min during hypotensive anesthesia | Drug | remifentanil |
Primary outcome
Creatinine Clearance
Time frame: 2hr after the start of hypotensive anesthesia
Hypotensive anesthesia means that we maintain the mean blood pressure between 55 \& 65 mmHg during surgery to decrease the blood loss. The specific time point is exactly 2hr after we star to lower the blood pressure.
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 13 Jun 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.
Ji Young Kim principal investigator
Severance hospital, YUHS
Questions about this trial
What is this clinical trial studying?
A study testing Nicardipine and remifentanil in people with Healthy Subjects, run by Yonsei University.
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: finished, as of the sponsor's last update on 13 Jun 2013. 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.
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?
Creatinine Clearance (time frame: 2hr after the start of hypotensive anesthesia). 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 13 Jun 2013.