NCT07664384

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

June 15, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

RIRSSpinal AnesthesiaGeneral AnesthesiaPerioperative Outcomes

Outcome Measures

Primary Outcomes (2)

  • 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.

    after the first postoperative month.

  • Total opioid consumption

    Total opioid consumption in the whole postoperative period is recorded

    Perioperative

Secondary Outcomes (3)

  • Pain assessement

    at 6 hours, 12 hours, 24 hours

  • Patient Satisfaction

    Perioperative

  • PACU stay

    Perioperative

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All eligible patients undergoing retrograde intrarenal surgery (RIRS)

You may qualify if:

  • Adult patients (≥18 years) scheduled for elective RIRS for renal stones \<2 cm.
  • Written informed consent obtained.

You may not qualify if:

  • History of previous ureteral surgery or known ureteral stricture.
  • Multiple or bilateral renal stones requiring staged procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena University

Qina, Qena Governorate, 83511, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor in Anesthesia, Intensive Care and Pain Management

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 24, 2026

Study Start

April 1, 2022

Primary Completion

February 1, 2025

Study Completion

February 15, 2025

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations