- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664384
General Versus Spinal Anesthesia in RIRS
Comparative Study of General Versus Spinal Anesthesia in Retrograde Intrarenal Surgery: Impact of Stone Size on Perioperative Outcomes
Study Overview
Status
Conditions
Detailed Description
Urolithiasis is a common urological condition with a rising global incidence and prevalence, largely attributed to lifestyle, dietary factors, and metabolic disorders. The lifetime risk of developing urinary stones is estimated to be approximately 10-15%, with a high recurrence rate that imposes a significant burden on healthcare systems. Advances in minimally invasive techniques have revolutionized the management of renal calculi, with retrograde intrarenal surgery (RIRS) emerging as a safe and effective modality for treating renal stones of varying sizes and locations.
RIRS, performed using flexible ureteroscopy and laser lithotripsy, has gained widespread acceptance due to its minimally invasive nature, reduced morbidity, and favorable stone-free rates. It is particularly advantageous for managing stones less than 2 cm, although its indications have expanded to include larger and more complex stones in selected cases. Despite these advantages, several factors influence the success and safety of RIRS, including stone size, location, density, surgeon experience, and perioperative management strategies.
Among perioperative factors, the choice of anesthesia plays a critical role in determining surgical conditions and patient outcomes. General anesthesia (GA) is traditionally preferred for RIRS as it provides optimal airway control, complete immobility, and controlled ventilation, thereby facilitating precise endoscopic manipulation. In contrast, spinal anesthesia (SA) has been proposed as an alternative due to its advantages such as reduced postoperative pain, lower incidence of nausea and vomiting, and avoidance of airway-related complications. However, concerns remain regarding its limitations, including patient movement, inadequate control of respiration, and hemodynamic instability.
By evaluating stone-free rates and perioperative complications across different stone size categories, this study seeks to provide evidence-based guidance for optimizing anesthesia selection in RIRS.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zeinab Mustafa Sayed, MD
- Phone Number: +02 01009071365
- Email: zeinab5aton@gmail.com
Study Locations
-
-
Qena Governorate
-
Qina, Qena Governorate, Egypt, 83511
- Qena University
-
Contact:
- Zeinab Mustafa, MD
- Phone Number: +02 01009071365
- Email: zeinab5aton@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥18 years) scheduled for elective RIRS for renal stones <2 cm.
- Written informed consent obtained.
Exclusion Criteria:
- History of previous ureteral surgery or known ureteral stricture.
- Multiple or bilateral renal stones requiring staged procedures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
General Anesthesia
patients in this group receive general anesthesia for RIRS: Intravenous anesthetic induction, Endotracheal intubation, controlled ventilation, muscle relaxation and inhalational anesthetic maintenance.
|
|
Spinal Anesthesia
patients in this group receive spinal anesthesia for RIRS: Standard spinal block using bupivacaine without sedation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone Free Rate
Time Frame: after the first postoperative month.
|
Follow-up Ultrasound/Computed Tomography (US/CT) to assess stone-free status after the first postoperative month.
Success was considered as residues of <2mm or absence of any stone fragments.
|
after the first postoperative month.
|
|
Total opioid consumption
Time Frame: Perioperative
|
Total opioid consumption in the whole postoperative period is recorded
|
Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessement
Time Frame: at 6 hours, 12 hours, 24 hours
|
pain is assessed uing Numerical Rating Scale where patients are asked to select a number from 0 to 10 to quantify their pain level where 0= no pain at all and 10= worst pain imaginable
|
at 6 hours, 12 hours, 24 hours
|
|
Patient Satisfaction
Time Frame: Perioperative
|
patients are asked to evaluate their satisfaction using a simple 4 point likert scale, where 4= Very Satisfied, 3= Satisfied, 2= Dissatisfied, 1= Very Dissatisfied
|
Perioperative
|
|
PACU stay
Time Frame: Perioperative
|
the duration of stay in PACU (postanesthetic care unit) is recorded
|
Perioperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AIP02942671
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Retrograde Intrarenal Surgery
-
Tarsus UniversityMersin UniversityCompleted
-
Afyonkarahisar Health Sciences UniversityCompleted
-
Sengkang General HospitalNot yet recruitingUrolithiasis | Retrograde Intrarenal Surgery | Renal Stone
-
St. Luke's Clinical Hospital, RussiaCompletedUrolithiasis | Retrograde Intrarenal Surgery | Ureteral Injury | Ureteral Access SheathRussia
-
Beni-Suef UniversityRecruitingRenal Stones | Retrograde Intrarenal Surgery | Ureteral Access Sheath PlacementEgypt
-
Al-Azhar UniversityRecruitingKidney Calculi | Radiation Exposure | Retrograde Intrarenal SurgeryEgypt
-
Al-Azhar UniversityRecruitingKidney Stone | Retrograde Intrarenal Surgery | Ureteral StentEgypt
-
Ankara Training and Research HospitalCompletedKidney Stone | Ureteral Access Sheath | Retrograde Intrarenal Surgery (RIRS)Turkey (Türkiye)
-
Muharrem BaturuUniversity of GaziantepCompletedRenal Stones | Retrograde Intrarenal Surgery | Thulium Fiber LaserTurkey (Türkiye)
-
Ankara City Hospital BilkentCompletedRetrograde Intrarenal Surgery | Renal StoneTurkey