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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01361516
• Other study ID #: 021711-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 11, 2011
• Last updated: May 25, 2011
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2011
• Source: Hadassah Medical Organization
• Contact: Fayez Saifi, MD
• Phone: 00972508946127
• Email: saififayez[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Other:
• Anaesthesia and Lithotripsy
The efficacy of stone fragmentation during lithotripsy procedure is compared under two types of anaesthesia

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Anesthesia complications	We are going to measure pain score (VAS 0-10)and postoperative hypoxemia, saturation below 90% well be considered as hypoxemic event	One year	No