The aim of this randomized double-blind clinical trial was to evaluate local effect of aminophylline on transureteral lithotripsy (TUL). A total of 120 patients, meeting eligibility criteria, were randomly allocated into the two equal groups. After establishing routine monitors and general anesthesia, the bladder was drained by catheter and then 150 cc Study irrigation solutions were entered the bladder through Ureteroscopy. Study irrigation solution in the control group was normal saline and in the intervention group was normal saline+ 250 mg aminophylline. After five minutes, bladder exposure to irrigation solution, ureteroscopy will be done. Duration the TUL, Success rate of stone removal, next need to ESWL, next need to use ureteral stents and DJ, tachycardia and hypertension during surgery, ureter evulsion during surgery, postoperative acute pyelonephritis associated with TUL will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106146803N1
Registration date:2011-07-22, 1390/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-22, 1390/04/31
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-08-06, 1390/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating local effect of aminophylline on transureteral lithotripsy (TUL)
Public title
Lowering ureter spasm to increase success rate in ureteroscopy and to remove stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signing written Informed consent, ASA class Ι-ΙΙ, Age between 15 and 45 years, Elective surgery, Lower ureteral stones smaller than 20 mm
Exclusion criteria: history of renal colic, history of TUL, renal anatomical abnormalities, renal malfunction, use of NSAIDs, steroids and opioids, Hypersensitivity to theophylline or any component of the formulation
Age
From 15 years old to 45 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
866-48175
Approval date
2011-01-18, 1389/10/28
Ethics committee reference number
89-96
Health conditions studied
1
Description of health condition studied
ureter stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter, Ureteric stone
Primary outcomes
1
Description
decreasing ureter espasm
Timepoint
once, during surgary
Method of measurement
increase succes rate in ureteroscopy and tul
Secondary outcomes
1
Description
time of TUL
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
2
Description
Rate of need for ESWL
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
3
Description
Rate of need for ureter stent
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
4
Description
Rate of need for ureter catheter
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
5
Description
Rate of the need for DJ
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
6
Description
Rate of ureter evulsion
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
7
Description
Rate of Acute pyelonephritis
Timepoint
after surgery
Method of measurement
Recorded in the questionnaire
8
Description
Success rate of stone removal
Timepoint
once, during surgary
Method of measurement
Recorded in the questionnaire
Intervention groups
1
Description
After draining the bladder by catheter, 150 cc Study irrigation solutions was entered the bladder through ureteroscopy. Study irrigation solution in the intervention group was normal saline+ 250 mg aminophylline. After five minutes, bladder exposure to irrigation solution ureteroscopy was done.
Category
Treatment - Surgery
2
Description
After draining the bladder by catheter, 150 cc Study irrigation solutions was entered the bladder through ureteroscopy. Study irrigation solution in the control group was normal saline. After five minutes, bladder exposure to irrigation solution ureteroscopy was done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
ayub barzegarnejad, MD, Urologist and renal transplant floship, Assistant professor
Street address
Imam Khomeini general Hospital, Amir St.
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati, MD
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ayub Barzegarnejad, MD
Position
Urologist and renal transplant floship
Other areas of specialty/work
Street address
serahe jouibar
City
Sari
Postal code
4814839953
Phone
+98 15 1222 4488
Fax
+98 15 1222 4488
Email
ayubbarzgarnejad@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini general Hospital, Amir St.
City
Sari
Postal code
4814839953
Phone
+98 15 1222 4488
Fax
+98 15 1222 4488
Email
a.firouzian@mazums.ac.ir ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)