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

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.

Study Overview

• Status: Unknown
• Conditions: Urolithiasis
• Intervention / Treatment: Other: Anaesthesia and Lithotripsy

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fayez Saifi, MD; Phone Number: 00972508946127; Email: saififayez@gmail.com

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
    • Principal Investigator: Fayez Saifi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Fayez Saifi, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): May 26, 2011
• Last Update Submitted That Met QC Criteria: May 25, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: ESWL; Urolithiasis; Sedation; General Anaesthesia; Stone Fragmentation efficacy
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 021711-HMO-CTIL