Retrograde Intrarenal SurgeryNCT07664384
General Versus Spinal Anesthesia in RIRS
An observational study of Retrograde Intrarenal Surgery, run by South Valley University at 1 site in Egypt.
Trial summary
The impact of anesthesia type on Retrograde Intrarenal Surgery (RIRS) outcomes remains a subject of ongoing debate. Several studies have compared general anesthesia (GA) and spinal anesthesia (SA) in endourological procedures, with conflicting results regarding operative time, complication rates, and stone-free… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retrograde Intrarenal Surgery
- Type of treatment
- Injection or infusion
- How many people
- 252 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 15 Feb 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients undergoing retrograde intrarenal surgery (RIRS)
Who may be able to join
- Adult patients (≥18 years) scheduled for elective RIRS for renal stones <2 cm.
- Written informed consent obtained.
Who cannot join
- History of previous ureteral surgery or known ureteral stricture.
- Multiple or bilateral renal stones requiring staged procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of General Versus Spinal Anesthesia in Retrograde Intrarenal Surgery: Impact of Stone Size on Perioperative Outcomes
The impact of anesthesia type on Retrograde Intrarenal Surgery (RIRS) outcomes remains a subject of ongoing debate. Several studies have compared general anesthesia (GA) and spinal anesthesia (SA) in endourological procedures, with conflicting results regarding operative time, complication rates, and stone-free outcomes. Importantly, the interaction between anesthesia type and stone characteristics-particularly stone size-has not been fully elucidated. Therefore, this study aims to conduct a retrospective comparative analysis of general versus spinal anesthesia in patients undergoing RIRS at Qena University Hospital, with particular emphasis on the effect of stone size stratification on perioperative outcomes.
Read the 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.
- Conditions
- Retrograde Intrarenal Surgery
- Keywords
- RIRS, Spinal Anesthesia, General Anesthesia, Perioperative Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Stone Free Rate
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.
Measured: after the first postoperative month.
Total opioid consumption
Total opioid consumption in the whole postoperative period is recorded
Measured: Perioperative
Secondary outcomes (3)
Pain assessement
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
Measured: at 6 hours, 12 hours, 24 hours
Patient Satisfaction
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
Measured: Perioperative
PACU stay
the duration of stay in PACU (postanesthetic care unit) is recorded
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Apr 2022
- Primary completion1 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde Intrarenal SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Mustafa Sayed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664384
- Sponsor's protocol ID
- AIP02942673
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of General Versus Spinal Anesthesia in Retrograde Intrarenal Surgery: Impact of Stone Size on Perioperative Outcomes
- ClinicalTrials.gov ID
- NCT07664384
- Acronym / sponsor ID
- AIP02942673
- Conditions
- Retrograde Intrarenal Surgery
- Keywords
- RIRS, Spinal Anesthesia, General Anesthesia, Perioperative Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 24 Jun 2026 (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.
The impact of anesthesia type on Retrograde Intrarenal Surgery (RIRS) outcomes remains a subject of ongoing debate. Several studies have compared general anesthesia (GA) and spinal anesthesia (SA) in endourological procedures, with conflicting results regarding operative time, complication rates, and stone-free outcomes. Importantly, the interaction between anesthesia type and stone characteristics-particularly stone size-has not been fully elucidated. Therefore, this study aims to conduct a retrospective comparative analysis of general versus spinal anesthesia in patients undergoing RIRS at Qena University Hospital, with particular emphasis on the effect of stone size stratification on perioperative outcomes.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients undergoing retrograde intrarenal surgery (RIRS)
Key inclusion criteria (2 listed)
- Adult patients (≥18 years) scheduled for elective RIRS for renal stones <2 cm.
- Written informed consent obtained.
Key exclusion criteria (2 listed)
- History of previous ureteral surgery or known ureteral stricture.
- Multiple or bilateral renal stones requiring staged procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Total opioid consumption
Time frame: Perioperative
Total opioid consumption in the whole postoperative period is recorded
3 secondary outcomes
Pain assessement
Time frame: at 6 hours, 12 hours, 24 hours
Patient Satisfaction
Time frame: Perioperative
PACU stay
Time frame: Perioperative
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 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Retrograde Intrarenal Surgery, run by South Valley University at 1 site in Egypt.
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 2 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 4 Aug 2026. 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 Egypt. 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?
Stone Free Rate (time frame: after the first postoperative month.). The study lists 2 primary outcomes in all. 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 4 Aug 2026.