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

NCT ID: NCT01361516

Last Updated: 2011-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-09-30

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

Conditions

Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intravenous sedation, General anaesthesia

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

Group Type: EXPERIMENTAL

Anaesthesia and Lithotripsy

Intervention Type: OTHER

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

Interventions

Anaesthesia and Lithotripsy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah Medical Organisation

Principal Investigators

Fayez Saifi, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Central Contacts

Fayez Saifi, MD

Role: CONTACT

saififayez@gmail.com

00972508946127

Hadas Lemberg, PhD

Role: CONTACT

lhadas@hadassah.org.il

0097226777572

Facility Contacts

Arik Tzukert, DMD

Role: primary

arik@hadassah.org.il

00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

lhadas@hadassah.org.il

00 972 2 6777572

Other Identifiers

021711-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id