Comparison of General Anaesthesia and Sedation on the Stone Fragmentation Efficacy of the Third Generation Lithotriptor

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

Sponsors

Lead sponsor: Hadassah Medical Organization

Source 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.

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

Overall Status Unknown status
Start Date July 2011
Completion Date September 2012
Primary Completion Date July 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation One year
Secondary Outcome
Measure Time Frame
Anesthesia complications One year
Enrollment 180
Condition
Intervention

Intervention type: Other

Intervention name: Anaesthesia and Lithotripsy

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

Arm group label: Intravenous sedation, General anaesthesia

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Fayez Saifi, MD Principal Investigator Hadassah Medical Organization
Overall Contact

Last name: Fayez Saifi, MD

Phone: 00972508946127

Email: [email protected]

Location
facility contact contact_backup investigator
Hadassah Medical Organization Arik Tzukert, DMD 00 972 2 6776095 [email protected] Fayez Saifi, MD Principal Investigator
Location Countries

Israel

Verification Date

April 2011

Responsible Party

Name title: Dr Saifi Fayez

Organization: Hadassah Medical Organisation

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Intravenous sedation, General anaesthesia

Arm group type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov