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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01361516
First received: May 11, 2011
Last updated: May 25, 2011
Last verified: April 2011
  Purpose

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 Intervention
Urolithiasis
Other: Anaesthesia and Lithotripsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of General Anaesthesia and Sedation on the Stone Fragmentation Efficacy of the Third Generation Lithotriptor

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    We are going to measure pain score (VAS 0-10)and postoperative hypoxemia, saturation below 90% well be considered as hypoxemic event


Estimated Enrollment: 180
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361516

Contacts
Contact: Fayez Saifi, MD 00972508946127 saififayez@gmail.com
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Fayez Saifi, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Fayez Saifi, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr Saifi Fayez, Hadassah Medical Organisation
ClinicalTrials.gov Identifier: NCT01361516     History of Changes
Other Study ID Numbers: 021711-HMO-CTIL
Study First Received: May 11, 2011
Last Updated: May 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Urolithiasis
ESWL
Stone Fragmentation efficacy
Sedation
General Anaesthesia

Additional relevant MeSH terms:
Urolithiasis
Urologic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014