In a randomized clinical trial, one hundred patients older than 18 years old who was referred to Shaheed Mofateh clinic of Yasuj with renal or upper ureteral stone larger than 20 millimeter and were candidate for PCNL, were randomly assigned in one of two groups. The intervention and control group underwent PCNL under spinal anesthesia and general anesthesia, respectively. Written informed consent was only given from the patients who were allocated to the intervention group. Spinal anesthesia was induced with Marcaine (15 mg) and Fentanyl (0.25 μg) injected intrathecally at the L3-L4 interspaces and head of bed tilted down for 5-10 minutes with checking level of anesthesia. Conscious sedation, during PCNL, was obtained with intravenous diazepam (2.5 mg or Midazolam (1 to 1.5 mg in bolus). General anesthesia was performed for the control group. PCNL was done under guide of fluoroscopy by standard technique and homodynamic and anesthetic variables such as oxygen saturation, duration of operation, hypotension and toleration of patients with complications and coast of anesthetic drugs are recorded during operation. Efficacy of procedure was evaluated by comparing clearance of system and residual stone between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138707201323N1
Registration date:2009-12-20, 1388/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-12-20, 1388/09/29
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-Chancelor for Research, Yasuj University of Medical Sciences and Health Services
Expected recruitment start date
2008-02-01, 1386/11/12
Expected recruitment end date
2009-12-30, 1388/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of PCNL under General and Spinal anesthesia
Public title
Comparison of efficacy and complications of PCNL under General and Spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years, presence of renal or upper ureteral stone, candidate for PCNL (multiple stones, staghorn stones, calyceal diverticule stones, stone which are resistant to ESWL, lower pole renal stone larger than >15 mm and other renal stone larger than 25 mm, upper ureteral stone >20mm, Having informed consent
Exclusion criteria: Any contraindication for regional anesthesia, presence of coagulopathy, acute infection ore urosepsis, presence of acute renal failure
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Imam Sajad hospital, Yasuj university of medical science,
City
Yasuj
Postal code
41417-75917
Approval date
2008-02-09, 1386/11/20
Ethics committee reference number
p/23/5/2619
Health conditions studied
1
Description of health condition studied
Renal and ureteral stones
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
Success rate of operation
Timepoint
during operation and two week later
Method of measurement
observation by nephroscope and fluroscopy during operation and with sonography and KUB two weeks later
Secondary outcomes
1
Description
Any complications of surgery
Timepoint
during operation to one week later
Method of measurement
report of patients and observation with examination of patients
Intervention groups
1
Description
Performing PCNL under spinal anesthesia at the prone position
Category
Treatment - Surgery
2
Description
Performing PCNL under general anesthesia at the prone position
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Behehti Hospital
Full name of responsible person
Dr Sadrollah Mehrabi
Street address
Shaheed Beheshti hospital, Montazeri street,Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research manager, Yasuj University of Medical Sciences
Full name of responsible person
Dr Mehdi Akbartabar
Street address
Emam Sajad Hospial, Yasuj University of Medical Sciences
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research manager, Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yasuj university of medical science
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate professor, Fellowship of Endourology, Urology Department, Yasuj University of Medical Scie
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street,
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7228
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate professor, Fellowship of Endourology, Urology Department, Yasuj University of Medical Scie
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street,
City
Yasuj
Postal code
759741417
Phone
+98 74 1222 6517
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate professor, Fellowship of Endourology, Urology Department, Yasuj University of Medical Scie
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street,
City
yasuj
Postal code
75917-41417
Phone
+98 74 1333 7228
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)