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Comparison of General Anaesthesia and Sedation on the Stone Fragmentation in Lithotripsy

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ClinicalTrials.gov Identifier: NCT01361516
Recruitment Status : Unknown
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Urolithiasis Other: Anaesthesia and Lithotripsy Not Applicable

Detailed Description:

The newer lithotriptors were reported to be less efficacious than the Dornier HM3 lithotriptor; and it is not clear the reason why there is decrease in efficacy of the new lithotriptors. Is it due to their small focal point or to increased patient movement while under intravenous sedation.When the patients get sedated then it will be difficult to control their respiratory movements. Retrospective comparisons suggest that intravenous may facilitate earlier discharge if no manipulation of the airway was done; but they are often associated with pain, hypoxemic respiratory episodes and disruptive movements during lithotripsy Instead of intravenous sedation, general anesthesia offer pain free procedures, no movement of the patient and controlled movement of the respiration leads to stable position of the urinary stones and receives persistent shock wave energy on to the stone bringing about better and early fragmentation. Hence we work on the hypothesis that the new generation shock wave lithotripters have a small focal point, every movement of the stone during the respiration or patient movement, will take the stone out of the focus and there results in loss of shocks leading to lithotripsy failure and use of more fluoroscopy for refocusing the stone.

Thus we think the proper choice of anesthetic technique will improve the efficacy of stone fragmentation in shock wave lithotripsy treatment at least in those who are obese and suffers from occult sleep- apnoea syndrome


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of General Anaesthesia and Sedation on the Stone Fragmentation Efficacy of the Third Generation Lithotriptor
Study Start Date : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intravenous sedation, General anaesthesia
IV sedation-ESWL under spontaneous respiration GA - ESWL under controlled respiration
Other: Anaesthesia and Lithotripsy
The efficacy of stone fragmentation during lithotripsy procedure is compared under two types of anaesthesia



Primary Outcome Measures :
  1. Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. Anesthesia complications [ Time Frame: One year ]
    We are going to measure pain score (VAS 0-10)and postoperative hypoxemia, saturation below 90% well be considered as hypoxemic event



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Mid or lower ureteral stones
  2. Bilateral renal stones
  3. Multiple stones
  4. Use of regional anesthesia
  5. Coagulopathies (thrombocytopenia, anticoagulation drugs)
  6. Suspected or documented difficult intubation
  7. History of chronic opioid abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361516


Contacts
Contact: Fayez Saifi, MD 00972508946127 saififayez@gmail.com
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Fayez Saifi, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Fayez Saifi, MD Hadassah Medical Organization

Responsible Party: Dr Saifi Fayez, Hadassah Medical Organisation
ClinicalTrials.gov Identifier: NCT01361516     History of Changes
Other Study ID Numbers: 021711-HMO-CTIL
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: April 2011

Keywords provided by Hadassah Medical Organization:
Urolithiasis
ESWL
Stone Fragmentation efficacy
Sedation
General Anaesthesia

Additional relevant MeSH terms:
Urolithiasis
Urologic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs