The Effect of Anesthesia Type on RIRS | NCT03373617

Studies
The Effect of Anesthesia Type on RIRS

NCT03373617

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 23, 2021Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Renal Stone

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2017Actual

Primary Completion Date

Dec 28, 2018Actual

Completion Date

Jan 14, 2019Actual

First Submitted Date

Dec 11, 2017

First Submission Date that Met QC Criteria

Dec 11, 2017

First Posted Date

Dec 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2021

Last Update Posted Date

Jul 23, 2021Actual

Name	Class
SMG-SNU Boramae Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring RIRS because of renal stone.

Exclusion Criteria:

disagreement for the trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients requiring RIRS because of renal stone

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung-Man Lee, M.D.,PhD	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center		Seoul		07061	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided