Protocol summary

Study aim
Comparison of the effect of using ultrasonography the traditional method on the success rate of spinal anesthesia by the resident of anesthesia
Design
design:clinical trial, randomized,Double-blind,has a control group,parallel,with 60 patients
Settings and conduct
The study will be conducted at Firoozgar and Rasul Akram Hospital, 60 patients were randomized to one another divided into two groups:Landmark and Ultrasound groups,in both groups of pations they are in sitting position, in landmark group spinal anesthesia is performed with the midline approch, in Ultrasound groups before spinal anesthesia ultrasound is selected from the lumbar spine
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with a BMI of between 24 and 30 who have an informed consent. Exclusion criteria:history of lumbar surgery,spinous process are touched hard or do not touched, pationts who have contraindication to spinal anesthesia
Intervention groups
Patients are divided into two groups:spainal anesthesia with ultrasonography and traditional methods.
Main outcome variables
Effect of ultrasonography

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140109016151N8
Registration date: 2019-02-22, 1397/12/03
Registration timing: registered_while_recruiting

Last update: 2019-02-22, 1397/12/03
Update count: 0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
compparison of the effect of usingultrasonography with the traditional method on success rate of spinal anesthesia by theresident of anesthesia
Public title
the effect of ultrasonography on the success rate of spinal anesthesia by the resident of anesthesia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
pationts with a BMI between 24 and 30 who have an informed consent for spinal anesthesia for surgery
Exclusion criteria:
history of lumbar spine surgery patients with a BMI greater than 30 spainose process are touched hard or do not touch patients who do not have an informed conset patients who have contraindications to spinal anesthesia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization,individual,sealed envelops,coin flipping
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and principal investigator are unaware of how to perform spinal anesthesia using the traditional or ultrasonographic metthod before starting
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Iran University of Medical Sciences
Street address
Fifth floor,Central building,Iran University of Medical Sciences,Hemmat Highway
City
Theran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-25, 1396/10/04
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511174004

Health conditions studied

1

Description of health condition studied
Spinal anesthesia by ultrasound
ICD-10 code
UOO-U85
ICD-10 code description
Special purposes

Primary outcomes

1

Description
success in spinal anesthesia
Timepoint
spinal anesthesia during surgery
Method of measurement
based on avisual scale VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: spinal anesthesia with ultrasonography
Category
Other

2

Description
Control group: Spinal anesthesia with the traditional method
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Dr.Alireza Pournajafian
Street address
Fifth floor,Central building,Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
a-pournajafian@tumss.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
DR.Morteza Naserbakht
Street address
Fifth floor,Central staff,Iran University of Medical Sciences,Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9024
Fax
+98 21 6650 9024
Email
a-pournajafian@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Alireza Pournajafian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
AnesthesiaDepartment,Firouzgar Hospital,Beh-afarin Street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Alireza Pournajafian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central staff,Iran University of Medical Sciences,Hemmat Highway
City
Teharn
Province
Tehran
Postal code
1449614535
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Sadat Pardis
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department Firiuzgar Hospital, Beh-afarin street
City
Tehran
Province
Tehran
Postal code
1964963659
Phone
+98 21 8894 2676
Email
Pardis.59@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data can be shared after making people unidentifiable
When the data will become available and for how long
Access period from 2021
To whom data/document is available
all people
Under which criteria data/document could be used
it is free for non-commerical use
From where data/document is obtainable
sending Email to:a-pournajafian@tums.ac.ir
What processes are involved for a request to access data/document
after receiving the individual and organizational specifications,the applicant will be responded up to one month
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