A comparative study on the effect of vitamin D 3 + Erythropoietin + Pentoxifylline and normal saline on the improvement of patients candidate for lumbar or neck laminectomy of Imam Reza Hospital in Kermanshah (2018-2019)
A comparative study on the effect of vitamin D 3 + Erythropoietin + Pentoxifylline and normal saline on the improvement of patients candidate for lumbar or neck laminectomy
Design
This study is a double-blind clinical trial. The study population will be included all patients that will be admitted to Imam Reza hospital in Kermanshah city.60 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza hospital of Kermanshah city, is double-blinded, in this way, participants and researchers will be blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for elective laminectomy; Age 20 to 70 years; Class I, II ASA patients
Exclusion criteria: Hemodynamic instability; Major disorders of the liver, kidney, or cardiovascular system, in particular, the atrial block;
The experience of previous treatment with calcium channel blockers
Drug use; Patients with coagulation disorders and emergency surgery
Intervention groups
The intervention group will receive pearl vitamin D3 with a dose of 50,000 units in a single dose a day before surgery+Erythropoietin 40000 units are given as a single dose one hour before surgery+Pentoxifylline pills with the dose of 400 mg one day before surgery.
The control group before the start of surgery will receive normal saline 9.0 %.
Main outcome variables
Quality of life, functional disability, pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N93
Registration date:2018-06-10, 1397/03/20
Registration timing:retrospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of vitamin D 3 + Erythropoietin + Pentoxifylline and normal saline on the improvement of patients candidate for lumbar or neck laminectomy of Imam Reza Hospital in Kermanshah (2018-2019)
Public title
The comparison of the effect of vitamin D 3 + Erythropoietin + Pentoxifylline and normal saline on the improvement of patients candidate for lumbar or neck laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for elective laminectomy
Age 20 to 70 years
Class I, II ASA patients
Exclusion criteria:
Hemodynamic instability
Major disorders of the liver, kidney, or cardiovascular system, in particular, the atrial block
The experience of previous treatment with calcium channel blockers
Drug use
Patients with coagulation disorders and emergency surgery
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table through of receive code
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, researchers, and data analyst will keep blinded to the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
ir.kums.rec.1396.707
Health conditions studied
1
Description of health condition studied
Laminectomy
ICD-10 code
M99
ICD-10 code description
vertebral column
Primary outcomes
1
Description
Quality of Life
Timepoint
After surgery and three months after surgery
Method of measurement
Using Quality of Life Questionnaire (SF-36)
2
Description
Functional disability
Timepoint
After surgery and three months after surgery
Method of measurement
Using Oswestry Disability Index
3
Description
Intensity of pain
Timepoint
After surgery and three months after surgery
Method of measurement
Using Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive pearl vitamin D3 with a dose of 50,000 units in a single dose a day before surgery+Erythropoietin 40000 units are given as a single dose one hour before surgery+Pentoxifylline pills with the dose of 400 mg one day before surgery.
Category
Treatment - Drugs
2
Description
Control group will receive normal saline
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Vahid bavandpour
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Dr_v_b2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Bavandpour
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Dr_v_b2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Bavandpour
Position
Resident of Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Dr_v_b2018@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Bavandpour
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Dr_v_b2018@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a 30-day period, the documents will be sent e-mail