- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957109
Influence of Anesthesia Methods on Surgical Outcomes and Renal Function
April 18, 2024 updated by: Seoul National University Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- older than 20 years with renal stones greater than 10 mm
Exclusion Criteria:
- patients who have urologic anatomical abnormalities
- patients with ASA status ≥ grade III, a contraindication for spinal anesthesia or RIRS, or unexpected intraoperative renal injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: general anesthesia
|
Other Names:
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Other: spinal anesthesia
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal function change according to anesthesia method
Time Frame: prior to procedure, and at 3 months after the procedure.
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using nuclear medicine tests with diethylenetriamine pentaacetic acid (99m Tc-DTPA)
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prior to procedure, and at 3 months after the procedure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2015
Primary Completion (Actual)
February 10, 2017
Study Completion (Actual)
February 10, 2017
Study Registration Dates
First Submitted
May 17, 2019
First Submitted That Met QC Criteria
May 17, 2019
First Posted (Actual)
May 21, 2019
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Urolithiasis
- Urinary Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Kidney Calculi
- Nephrolithiasis
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- 16-2015-75
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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