NCT01361516

Brief Summary

The aim of the study is to compare the impact intravenous sedation versus general anesthesia on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 26, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

May 11, 2011

Last Update Submit

May 25, 2011

Conditions

Urolithiasis

Keywords

UrolithiasisESWLStone Fragmentation efficacySedationGeneral Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation

    Stone fragmentation is measured as disappearence of the stone on flouroscopic monitoring and number of shocks utilised to break the stone during the lithotripsy treatment under general anesthesia (controlled ventilation) or with intravenous sedation(spontaneous ventilation)will be compared in this study.

    One year

Secondary Outcomes (1)

  • Anesthesia complications

    One year

Study Arms (1)

Intravenous sedation, General anaesthesia

EXPERIMENTAL

IV sedation-ESWL under spontaneous respiration GA - ESWL under controlled respiration

Other: Anaesthesia and Lithotripsy

Interventions

Anaesthesia and LithotripsyOTHER

The efficacy of stone fragmentation during lithotripsy procedure is compared under two types of anaesthesia

Intravenous sedation, General anaesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal or upper ureteral stone of less than 2cm
  • A.S.A Grade 1.2.3
  • Age above 18 years

You may not qualify if:

  • Mid or lower ureteral stones
  • Bilateral renal stones
  • Multiple stones
  • Use of regional anesthesia
  • Coagulopathies (thrombocytopenia, anticoagulation drugs)
  • Suspected or documented difficult intubation
  • History of chronic opioid abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

AnesthesiaLithotripsy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaTherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Fayez Saifi, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fayez Saifi, MD

CONTACT

00972508946127saififayez@gmail.com

Hadas Lemberg, PhD

CONTACT

0097226777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2011

First Posted

May 26, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

May 26, 2011

Record last verified: 2011-04

Locations

IL(1)