Can Trajectory Nor-epinephrine Infiltration Reduce Blood... | NCT05035303

Studies
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?

NCT05035303

Sponsor

Benha University

Status

Completed

Last Update Posted

Jan 5, 2022Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Blood Loss, Surgical

Interventions

Nor-Epinephrine injection versus saline during PCNL

Countries

Egypt

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

Jan 2022

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

Mar 10, 2020Actual

Primary Completion Date

Nov 10, 2021Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Aug 30, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Sep 5, 2021Actual

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

Jan 4, 2022

Last Update Posted Date

Jan 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change & blood loss is estimated and will compared.

Detailed Description

All patients of are positioned in lithotomy position and 6 F open tip ureteral catheter is fixed by cystoscope. Then, A pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 Gauge (G) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 G Chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an Amplatz sheath was inserted.

nephroscope is used for stones disintegration by pneumatic or laser lithotripter . Fragments are washed out or removed by forceps.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nor-Epinephrine (NE)-Group	Active Comparator	The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.	Procedure: Nor-Epinephrine injection versus saline during PCNL
S-Group	Placebo Comparator	The PCNL tract is infiltrated by Normal Saline before its dilatation.	Procedure: Nor-Epinephrine injection versus saline during PCNL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nor-Epinephrine injection versus saline during PCNL	Procedure	The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.	Nor-Epinephrine (NE)-Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemoglobin drop	the lower drop is better	72 hours post intervention
blood loss	the lower loss is better	immediately after surgery

Secondary Outcomes

Measure	Description	Time Frame
stone free rate	the higher is better	within 3 months post-operative
adverse events	the lower is better	within 30 days post-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

renal stones>2 cm

Exclusion Criteria:

coagulopathy, congenital anomalies, active Urinary tract infections

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Waleed El-Shaer	Faculty of medicine, Banha university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banha University Hospitals		Banhā	Kalubiaya	13518	Egypt
Banha university hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016063	Blood Loss, Surgical

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007431	Intraoperative Complications

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