Comparison of General Anaesthesia and Sedation on the Stone Fragmentation in Lithotripsy
Primary Purpose
Urolithiasis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Anaesthesia and Lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring Urolithiasis, ESWL, Stone Fragmentation efficacy, Sedation, General Anaesthesia
Eligibility Criteria
Inclusion Criteria:
- Renal or upper ureteral stone of less than 2cm
- A.S.A Grade 1.2.3
- Age above 18 years
Exclusion Criteria:
- 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
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intravenous sedation, General anaesthesia
Arm Description
IV sedation-ESWL under spontaneous respiration GA - ESWL under controlled respiration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Anesthesia complications
We are going to measure pain score (VAS 0-10)and postoperative hypoxemia, saturation below 90% well be considered as hypoxemic event
Full Information
NCT ID
NCT01361516
First Posted
May 11, 2011
Last Updated
May 25, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01361516
Brief Title
Comparison of General Anaesthesia and Sedation on the Stone Fragmentation in Lithotripsy
Official Title
Comparison of General Anaesthesia and Sedation on the Stone Fragmentation Efficacy of the Third Generation Lithotriptor
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Urolithiasis, ESWL, Stone Fragmentation efficacy, Sedation, General Anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous sedation, General anaesthesia
Arm Type
Experimental
Arm Description
IV sedation-ESWL under spontaneous respiration GA - ESWL under controlled respiration
Intervention Type
Other
Intervention Name(s)
Anaesthesia and Lithotripsy
Intervention Description
The efficacy of stone fragmentation during lithotripsy procedure is compared under two types of anaesthesia
Primary Outcome Measure Information:
Title
Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Anesthesia complications
Description
We are going to measure pain score (VAS 0-10)and postoperative hypoxemia, saturation below 90% well be considered as hypoxemic event
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Renal or upper ureteral stone of less than 2cm
A.S.A Grade 1.2.3
Age above 18 years
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fayez Saifi, MD
Phone
00972508946127
Email
saififayez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
0097226777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fayez Saifi, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Fayez Saifi, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of General Anaesthesia and Sedation on the Stone Fragmentation in Lithotripsy
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