Kidney CalculiNCT03957109
Influence of Anesthesia Methods on Surgical Outcomes and Renal Function
A study testing general anesthesia in people with Kidney Calculi, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Patients who underwent retrograde intrarenal surgery (RIRS) were randomly allocated to general anesthesia (GA) or spinal anesthesia (SA) groups. Renal function was assessed using estimated glomerular filtration rate, and relative renal function was evaluated using nuclear medicine tests. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2015to 10 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 20 years with renal stones greater than 10 mm
Who cannot join
- patients who have urologic anatomical abnormalities
- patients with ASA status ≥ grade III, a contraindication for spinal anesthesia or RIRS, or unexpected intraoperative renal injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Anesthesia Methods on Surgical Outcomes and Renal Function in Retrograde Intrarenal Stone Surgery: a Prospective, Randomized Controlled Study
Patients who underwent retrograde intrarenal surgery (RIRS) were randomly allocated to general anesthesia (GA) or spinal anesthesia (SA) groups. Renal function was assessed using estimated glomerular filtration rate, and relative renal function was evaluated using nuclear medicine tests. Maneuverability and accessibility were evaluated after every surgery. We analyzed the influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal surgery in a prospective, randomized controlled study.
- Conditions
- Kidney Calculi
- Being tested
- general anesthesia
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaProcedure or surgery
Also called spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Other | general anesthesia Receives: Procedure: general anesthesia |
| spinal anesthesia | Other | spinal anesthesia Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function change according to anesthesia method
using nuclear medicine tests with diethylenetriamine pentaacetic acid (99m Tc-DTPA)
Measured: prior to procedure, and at 3 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start18 Sep 2015
- Primary completion10 Feb 2017
- Study completion10 Feb 2017
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 Kidney CalculiStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957109
- Sponsor's protocol ID
- 16-2015-75
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 19 Apr 2024
- Results posted
- No
Publications
Kwon O, Lee JM, Park J, Cho MC, Son H, Jeong H, Ryang SH, Cho SY. Influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal stone surgery: a prospective, randomized controlled study. BMC Anesthesiol. 2019 Dec 23;19(1):239. doi: 10.1186/s12871-019-0901-9.
PubMed 31870417
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthesia Methods on Surgical Outcomes and Renal Function in Retrograde Intrarenal Stone Surgery: a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03957109
- Acronym / sponsor ID
- 16-2015-75
- Conditions
- Kidney Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 21 May 2019 (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.
Patients who underwent retrograde intrarenal surgery (RIRS) were randomly allocated to general anesthesia (GA) or spinal anesthesia (SA) groups. Renal function was assessed using estimated glomerular filtration rate, and relative renal function was evaluated using nuclear medicine tests. Maneuverability and accessibility were evaluated after every surgery. We analyzed the influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal surgery in a prospective, randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | Other | Procedure: general anesthesiageneral anesthesia |
| spinal anesthesia | Other | Procedure: general anesthesiaspinal anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older than 20 years with renal stones greater than 10 mm
Key exclusion criteria (2 listed)
- patients who have urologic anatomical abnormalities
- patients with ASA status ≥ grade III, a contraindication for spinal anesthesia or RIRS, or unexpected intraoperative renal injury
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 |
|---|---|---|
| general anesthesiaAlso: spinal anesthesia | Procedure or surgery | general anesthesia, spinal anesthesia |
Primary outcome
Renal function change according to anesthesia method
Time frame: prior to procedure, and at 3 months after the procedure.
using nuclear medicine tests with diethylenetriamine pentaacetic acid (99m Tc-DTPA)
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 19 Apr 2024.
- Derived from this study: PubMed 31870417Kwon O, Lee JM, Park J, Cho MC, Son H, Jeong H, Ryang SH, Cho SY. Influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal stone surgery: a prospective, randomized controlled study. BMC Anesthesiol. 2019 Dec 23;19(1):239. doi: 10.1186/s12871-019-0901-9.
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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.
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 general anesthesia in people with Kidney Calculi, 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 1 inclusion and 2 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 19 Apr 2024. 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?
Renal function change according to anesthesia method (time frame: prior to procedure, and at 3 months after the procedure.). 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 NCT03957109, 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 19 Apr 2024.