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Anesthesia Type on Percutaneous Nephrolithotomy in Aging Male

Sponsor
Sedat Önen (Other)
Overall Status
Completed
CT.gov ID
NCT05431049
Collaborator
Bursa City Hospital (Other)
184
Enrollment
1
Location
6.4
Actual Duration (Months)
28.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous nephrolithotomy surgery (PNL)

Detailed Description

Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be divided into two groups according to the type of anesthesia. The results determined in both arms will be compared with appropriate statistical methods.

Study Design

Study Type:
Observational
Actual Enrollment :
184 participants
Observational Model:
Case-Crossover
Time Perspective:
Retrospective
Official Title:
The Effect of Anesthesia Type on the Outcomes of Percutaneous Nephrolithotomy in Aging Male
Actual Study Start Date :
May 7, 2021
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Nov 17, 2021

Arms and Interventions

Arm Intervention/Treatment
combined spino-epidural anesthesia (CSEA)

Percutaneous nephrolithotomy under combined spino-epidural anesthesia

Procedure: Percutaneous nephrolithotomy surgery (PNL)
Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.
Other Names:
  • spino-epidural anesthesia (CSEA)
  • general anesthesia (GA)

    		•
    general anesthesia (GA)

    Percutaneous nephrolithotomy under general anesthesia

    Procedure: Percutaneous nephrolithotomy surgery (PNL)
    Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.
    Other Names:
  • spino-epidural anesthesia (CSEA)
  • general anesthesia (GA)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Stone free rates [Post-surgery day 1]

      These are the success percentages depending on the outcome of the surgical procedure in both groups.

    2. Complication rates [During surgery to 24 hours after surgery]

      These are the complication percentages depending on the outcome of the surgical procedure in both groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 100 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of Renal Stone Disease

    • Above 65 years of age

    • Male sex

    Exclusion Criteria:

    • Having low hemoglobin level before surgery

    • Presence of hematology disease causing bleeding diathesis

    • Presence of stones in an ectopic or transplanted kidney

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa City Hospital Bursa Turkey

    Sponsors and Collaborators

    • Sedat Önen
    • Bursa City Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sedat Önen, Associate Professor, Bursa City Hospital
    ClinicalTrials.gov Identifier:
    NCT05431049
    Other Study ID Numbers:
    • 2021-8/4
    First Posted:
    Jun 24, 2022
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Calculi
    Anesthetics

    Study Results

    No Results Posted as of Jun 24, 2022