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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT01361516

Collaborator

(none)

180

Enrollment

Location

Arm

14.1

Duration (Months)

12.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis	Other: Anaesthesia and Lithotripsy	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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