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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01361516
Enrollment
180
Registered
2011-05-26
Start date
2011-07-31
Completion date
2012-09-30
Last updated
2011-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Keywords

Urolithiasis, ESWL, Stone Fragmentation efficacy, Sedation, General Anaesthesia

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

Interventions

OTHERAnaesthesia and Lithotripsy

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

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedationOne yearStone 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

MeasureTime frameDescription
Anesthesia complicationsOne yearWe are going to measure pain score (VAS 0-10)and postoperative hypoxemia, saturation below 90% well be considered as hypoxemic event

Countries

Israel

Contacts

Primary ContactFayez Saifi, MD
saififayez@gmail.com00972508946127
Backup ContactHadas Lemberg, PhD
lhadas@hadassah.org.il0097226777572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026