The Effect of Anesthesia Type on RIRS

July 22, 2021 updated by: Jung-Man Lee, Seoul National University Hospital

The Effect of Anesthesia Type on the Surgical Field in Retrograde Intrarenal Surgery With Flexible Ureteroscopy in Renal Stone Patients

Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons and make them tired. This can lead in tissue injury from lasing.

The purpose of this study is to investigate the stability of monitoring of surgical field which is assessed by surgeon.

Study Overview

Status

Completed

Conditions

Detailed Description

RIRS with flexible ureteroscopy is usually performed under general anesthesia, spinal anesthesia.

Anesthesia type is decided in the basis of medical condition of a patient and patient's preference.

This study is a prospective observational study. During operation after induction of anesthesia, surgeons will be asked how visual stability of surgical field on monitor is (scale from 0 to 10).

According to anesthesia type (general anesthesia, spinal anesthesia), 34 patients will be enrolled and investigated in each group.

Investigators will compare the scale for visual stability of surgical field during RIRS.

Study Type

Observational

Enrollment (Actual)

66

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients requiring RIRS because of renal stone

Description

Inclusion Criteria:

  • Patients requiring RIRS because of renal stone.

Exclusion Criteria:

  • disagreement for the trial.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
General anesthesia group
Patients in general anesthesia group are scheduled to undergo RIRS under general anesthesia.
Spinal anesthesia group
Patients in spinal anesthesia group are scheduled to undergo RIRS under spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS for stability of monitoring
Time Frame: intraoperative
VAS (from 1 to 10) for stability in monitoring of surgical field, which is assessed by surgeons
intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jung-Man Lee, M.D.,PhD, SMG-SNU Boramae Medical Center

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)

December 13, 2017

Primary Completion (Actual)

December 28, 2018

Study Completion (Actual)

January 14, 2019

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2017-10

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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