Comparison of success and complication rates between patients undergoing percutaneous nephrolithotomy (PCNL) under general and spinal anesthesia in a randomized clinical trial
The aim of this study is to compare success and complication rates of PCNL in patients undergoing general and spinal anesthesia in a single blinded randomised clinical trial . the population under study comprises all older than 16 years patients who are candidate for PCNL surgery for renal stone . exclusion criteria are being single kidney, ceatinin higher than 2.5, renal anatomic abnormalities and a history of ipsilateral renal surgery . sample size has been estimated 120. According to a previously established allocation sequence, patients are allocated to either type of general or spinal anesthesia before surgery. afterwards, surgical success and intraoperational and postoperational complication rates are compared between two types of anesthesia, also anesthesic complication rates will also be compared between general and spinal anesthesia .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111187457N6
Registration date:2012-02-19, 1390/11/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-19, 1390/11/30
Registrant information
Name
Shabnam Golshan
Name of organization / entity
Urology and Nephrology Research Center (UNRC)
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
shgolshan@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of success and complication rates between patients undergoing percutaneous nephrolithotomy (PCNL) under general and spinal anesthesia in a randomized clinical trial
Public title
Success and complications of percutaneous nephrolithotomy (PCNL) under general and spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all the patients older than 16 years who present with pelvis and/or calyceal stone and are candidate for PCNL surgery. Exclusion criteria:
1- lack of consent for either of general or spinal anesthesia; 2- complete staghorn stone defined as pelvic stone concomitant with at least three calyces stones' 3- single kidney or single functional kidney ptients; 4- patients with a history of ipsilateral renal surgery; 5- patients with high serum creatinin levels ( higher than 2.5) due to prerenal, renal or postrenal azotemia; 6- congenital anatomic abnormality in the kidney undergoing surgery (malrotation, pelvic kidney, horse-shoe kidney); 7- patients who are suitable only for one type of anesthesia due to medical conditions, body habitus (pinal deformity, dificult-to-intubate larynx), etc; 8- any history of hypersensitivity to remifentanyl, propofol, atracurium, spinal anesthesia material; 9- opioid or alcohol addiction and 10- BMI higher than 30
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Urology and nephrology Research Center Ethics Committee
Street address
No#99, 9th Boostan, Pasdaran Ave.
City
Tehran
Postal code
Approval date
2011-12-22, 1390/10/01
Ethics committee reference number
21689
Health conditions studied
1
Description of health condition studied
renal stone
ICD-10 code
N 20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Stone clearance
Timepoint
24 hours after intervention
Method of measurement
Abdominal X-ray
2
Description
Transfusion rate
Timepoint
From start of surgery untill discharge
Method of measurement
Number of pack cells transfused
3
Description
Opioid requirement
Timepoint
Opioid required during the first 48 hours after procedure
Method of measurement
Infusion pump contolled by patient
4
Description
Volume of urinary leakage
Timepoint
During the time of hospitalization
Method of measurement
Amount of urinary leakage through nephrostomy tract
5
Description
Visceral injury
Timepoint
During the procedure
Method of measurement
According to the sign and symptoms of patient
6
Description
Hemoglobin changes
Timepoint
Before and 6 hours after procedure
Method of measurement
Mg/dL according to the lab data
7
Description
Serum creatinin changes
Timepoint
Before and 6 hours after procedure
Method of measurement
Mg/dL accoding to the lab data
Secondary outcomes
1
Description
Fluoroscopy time
Timepoint
At the end of procedure
Method of measurement
Time of exposure to X-ray
2
Description
Hospitalization time
Timepoint
From admission to discharge from hospital
Method of measurement
Days of hospitalization according to hospital file
Intervention groups
1
Description
In the intervention group in which PCNL will be performed under spinal anesthesia, while the patient is positioned in the ipsilateral decubitus, using a 25 gauge quinke needle 0.25 mg/kg of bupivacaine will be introduced into the thecal space . patient will remain in this position for 3 minutes and then surgery starts .
Category
Treatment - Surgery
2
Description
In control group in which PCNL will be performed under general anesthesia, anesthesia is induced with 2mg/kg of propofol plus 0.5 mg/kg of atracurium, then is continued with with 0.1 mg/kg.min of propofol plus 0.05 μg/kg.min of remifentanyl
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad hospital
Full name of responsible person
Akbar Nouralizadeh , Urologist , Associate professor
Street address
No#99, 9th Boostan, Pasdaran Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology and nephrology research center
Full name of responsible person
Shabnam Golshan
Street address
No3103, 9th Boostan, Pasdaran Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and nephrology research center
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
Shahid Labbafinejad Medical Center
Full name of responsible person
Dr Hossein Kilani
Position
MD, Resident of Urology
Other areas of specialty/work
Street address
No#99, 9th Boostan, Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2258 8016
Fax
Email
hossainkilani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Labbafinejad Medical Center
Full name of responsible person
Dr Mohammad Hossein Soltani
Position
Assistant professor of urology
Other areas of specialty/work
Street address
No#99, 9th Boostan, Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2258 8016
Fax
Email
mhsoltani@iurtc.org.ir
Web page address
www.iurtc.org.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Labbafinejad Medical Center
Full name of responsible person
Dr Hossein Kilani
Position
MD, Resident of Urology
Other areas of specialty/work
Street address
No#99, 9th Boostan, Padaran Ave.
City
Tehran
Postal code
Phone
+98 21 2258 8016
Fax
Email
hossainkilani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)