Anesthesia Type on Percutaneous Nephrolithotomy in Aging Male

June 18, 2022 updated by: Sedat Önen

The Effect of Anesthesia Type on the Outcomes of Percutaneous Nephrolithotomy in Aging Male

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Above 65 years of age, male sex and having kidney stone

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rates
Time Frame: Post-surgery day 1
These are the success percentages depending on the outcome of the surgical procedure in both groups.
Post-surgery day 1
Complication rates
Time Frame: During surgery to 24 hours after surgery
These are the complication percentages depending on the outcome of the surgical procedure in both groups.
During surgery to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sedat Önen

Collaborators

Bursa City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 18, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-8/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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