NCT07114250

Brief Summary

The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in PCNL operation in supine position.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

May 30, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

August 11, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

General AnesthesiaPercutaneous nephrolithotomySpinal AnesthesiaNephrolithiasis

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Degree of patient satisfaction will be assessed according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)

    24 hours

Secondary Outcomes (1)

  • Visual analog scale

    24 hours

Study Arms (2)

Spinal Anesthesia

EXPERIMENTAL

Spinal Anesthesia: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia

Procedure: spinal anesthesia

General Anesthesia

EXPERIMENTAL

Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia.

Procedure: General Anesthesia

Interventions

Spinal Anesthesia group: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia

Spinal Anesthesia

General Anesthesia : Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia

General Anesthesia

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 21 years old.
  • Both sexes.
  • American Society of Anesthesiologists physical status (I- II).
  • Patient with single renal stone size 2-3cm prepared for supine Percutaneous nephrolithotomy

You may not qualify if:

  • Patient refusal.
  • Pregnancy
  • Morbid obese with Body mass index \> 35 kg/m2.
  • Contraindication for spinal anesthesia.
  • Renal anomalies (horseshoe kidney, ectopic kidney).
  • Presence of multiple stones or staghorn stones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Anesthesia, SpinalAnesthesia, General

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Aya Hamouda, Resident

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Hamouda, Resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations