In this controlled randomized double blind clinical trial, after approval of research and ethic committee of medical faculty , for study of bleeding in spinal anesthesia versus general anesthesia in percutaneous nephrolithotripsy, 80 patient with 18-80 years old and ASA class1 whom candidate for elective percutaneous nephrolithotripsy was selected for study.patient who had significant comorbidity and sensitivity to local anesthetic drugs was excluded from study. after receiving inform consent they are divided randomly to two groups. in the group1(general anesthesia) received 5mg/kg nesdonal and maintained with 100 microgr/kg/min of propofol, in group2(spinal anesthesia)3cc bupivacain into subarachnoid space was administerd. Estimated blood loss and transfusion rate in two groups, then collected data were analyzed by SPSS16 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101175632N1
Registration date:2011-09-01, 1390/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Gholamhosain Shirkhany
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6687 8820
Email address
hshirkhany@irimc.org
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, tehran University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of blood loss volume in patient with Percutaneous nephrolithotripsy between spinal & general anesthesia. lithotripsy
Public title
effect of general anesthesia and spinal anesthesia in percutaneous nephrolithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:age above 18 years-kidney stone with 20-40mm-American Society of Anesthesiologists score =I
exclusion ceriteria:significant comorbidity-pregnancy-severe obesity-sensitivity to local anesthetic.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 the tehran university of medical science
Street address
اhemmat pardis, hemmat free way, medicin faculty, research deputy
City
tehran
Postal code
1969714713
Approval date
2009-08-27, 1388/06/05
Ethics committee reference number
4397
Health conditions studied
1
Description of health condition studied
stone in kidney
ICD-10 code
Diseases o
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
blood loss volume
Timepoint
during intervention
Method of measurement
visual estimation of blood loss in the buttle as vell as counting the bloody gauzes
2
Description
need for transfusion
Timepoint
after intervention
Method of measurement
refer to patient file
Secondary outcomes
1
Description
blood pressure
Timepoint
during procedure
Method of measurement
automatic BP monitoring
Intervention groups
1
Description
in the spinal group 3cc bupivacain into subarachnoid space was administerd.
Category
Treatment - Drugs
2
Description
in the general anesthesia group received 5mg/kg nesdonal and maintained with 100 microgr/kg/min of propofol