Comparison of the effect of preloading with normal saline solution and voluven on the spread of sensory block with hyperbaric bupivacaine after spinal anesthesia
The overall objective of the project: determination of the effect of preloading with normal saline and Voluven on the distribution of block with hyperbaric bupivacaine for spinal anesthesia
study design: randomized, double-blind
study population: all patients 20 to 70years, scheduled for lower abdominal surgery that can be done With spinal anesthesia
Inclusion criteria: a) all patients 20 to 70 years, scheduled for lower abdominal surgery with spinal anesthesia B) ASA I-II
- Non-inclusion criteria: a) the inability to collaborate and determine the level of anesthesia by patients, b) patients with Spinal disorderand deformity d) contraindications to spinal anesthesia e) contraindications for use of voluven a) lack of consent and cooperation of the patient) patients needing transfusion or infusion of additional fluids during surgery due to hemodynamic instability
sample size: 60
Intervention: Selected patients will be divided into two equal groups of 30. Patients randomized, double-blind fall into one of two groups. The first group of 10 to 15 minutes before spinal anesthesia 10ml / kg of saline solution and a second group 5ml / kg Voluven solution within 10 to 15 minutes will receive.
Intervention time: before spinal anesthesia
outcomes: the level of block
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121616956N7
Registration date:2016-06-27, 1395/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Hassan Mohammadipour Anvari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dr.anvari22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of preloading with normal saline solution and voluven on the spread of sensory block with hyperbaric bupivacaine after spinal anesthesia
Public title
Compare the effect of preloading in spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients 20 to 70 years, scheduled for lower abdominal surgery with spinal anesthesia: ASA I-II
Excinclusion criteria: the inability to collaborate and determine the level of anesthesia by patients: patients with Spinal disorder and deformity: contraindications to spinal anesthesia: contraindications for use of voluven: lack of consent and cooperation of the patient: patients needing transfusion or infusion of additional fluids during surgery due to hemodynamic instability
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz University of Medical Sciences
Street address
Tabriz, golgasht street, Tabriz University of Medical Sciences, Central Building 2, third floor, Department of Research and Technology
City
tabriz
Postal code
Approval date
2015-10-12, 1394/07/20
Ethics committee reference number
TBZMED.REC.1394.678
Health conditions studied
1
Description of health condition studied
The effect of pretreatment with various solutions at the level of sensory block in the spinal anesthesia
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Sensory block level
Timepoint
Every 5 minutes to 30 minutes and then 60 minutes after spinal anesthesia and 90
Method of measurement
pinprick test
Secondary outcomes
1
Description
Headache
Timepoint
Postoperative
Method of measurement
Ask the patient
2
Description
blood pressure
Timepoint
Every 5 minutes to 30 minutes and then every 15 minutes until the end of surgery
Method of measurement
By monitoring
3
Description
Heart rate
Timepoint
Every 5 minutes to 30 minutes and then every 15 minutes until the end of surgery
Method of measurement
By monitoring
Intervention groups
1
Description
Intervention group 1: 10 to 15 minutes before spinal anesthesia 10ml / kg normal saline within 10 to 15 minutes will receive
Category
Prevention
2
Description
Intervention group 2: 10 to 15 minutes before spinal anesthesia 5ml / kg voluven within 10 to 15 minutes will receive.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
doctor Hassan Mohammad Pour Anvari
Street address
tabriz.golgasht street
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,tabriz University of Medical Sciences
Full name of responsible person
soleimanpour dr.
Street address
Golgasht Street.medical school
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,tabriz 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
tabriz University of Medical Sciences
Full name of responsible person
Doctor Mahmoud Eidi
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz .Golgasht street
City
tabriz
Postal code
Phone
+41 33343594
Fax
Email
eidym@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hassan MohammadiPour Anvari
Position
Assistant Professor
Other areas of specialty/work
Street address
Golgasht street
City
Tabizr
Postal code
Phone
+98 41 3441 8794
Fax
Email
dranvari22@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical Science University
Full name of responsible person
Dr. Mojtaba Mohammadzade Lameh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Golgasht. street
City
Tabriz
Postal code
Phone
+41 34418794
Fax
Email
drmojtaba@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)