Back to resultsInfluence of Anesthesia Methods on Surgical Outcomes and Renal Function
Primary Purpose
Kidney Calculi
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
general anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Calculi
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
general anesthesia
spinal anesthesia
Arm Description
general anesthesia
spinal anesthesia
Outcomes
Primary Outcome Measures
Renal function change according to anesthesia method
using nuclear medicine tests with diethylenetriamine pentaacetic acid (99m Tc-DTPA)
Secondary Outcome Measures
Full Information
NCT ID
NCT03957109
First Posted
May 17, 2019
Last Updated
May 17, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03957109
Brief Title
Influence of Anesthesia Methods on Surgical Outcomes and Renal Function
Official Title
Influence of Anesthesia Methods on Surgical Outcomes and Renal Function in Retrograde Intrarenal Stone Surgery: a Prospective, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2015 (Actual)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
February 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
general anesthesia
Arm Type
Other
Arm Description
general anesthesia
Arm Title
spinal anesthesia
Arm Type
Other
Arm Description
spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
general anesthesia
Other Intervention Name(s)
spinal anesthesia
Primary Outcome Measure Information:
Title
Renal function change according to anesthesia method
Description
using nuclear medicine tests with diethylenetriamine pentaacetic acid (99m Tc-DTPA)
Time Frame
prior to procedure, and at 3 months after the procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31870417
Citation
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.
Results Reference
derived
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Influence of Anesthesia Methods on Surgical Outcomes and Renal Function
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