Comparison of the effect of intra venous magnesium sulfate and succinylcholine in prevention of muscle contraction due to obturator nerve stimulation in Transurethral Resection Bladder Tumor surgery.
Comparison between the effect of intra venous magnesium sulfate and succinylcholine in prevention of muscle contraction due to obturator nerve stimulation in Transurethral Resection Bladder Tumor surgery.
Design
This study is a double-blinded clinical trial. The study population will include all patients referred to Imam Reza hospital of Kermanshah. 118 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study will be conducted in Imam Reza hospital of Kermanshah city is double blinded one, that Physicians and participants have been kept blind about the allocation of intervention groups and drug doses. In both groups, magnesium, potassium, and calcium are measured before surgery and recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with ASA Class1,2; patients are candidates for bladder tumor resection through the urethra.
Exclusion criteria: kidney failure with GFR <45 ml / min; heart failure, heart rhythm disturbances, calcium and magnesium plasma disorders, hemodynamic disorders; taking drugs that affect calcium and magnesium transfer in muscle; musculoskeletal diseases; hemodynamic instability; taking medications that affect the transmission of neuromuscular messages.
Intervention groups
The first intervention group will receive an intravenous infusion of Saxil Neil Colin bolus1 mg/kg over 10 minutes. The second intervention group will receive 40 mg/kg intravenous magnesium sulfate as an infusion over 10 minutes.
Main outcome variables
Muscular pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N152
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
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
2020-06-24, 1399/04/04
Expected recruitment end date
2020-08-25, 1399/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intra venous magnesium sulfate and succinylcholine in prevention of muscle contraction due to obturator nerve stimulation in Transurethral Resection Bladder Tumor surgery.
Public title
The effect of intravenous magnesium sulfate and succinylcholine in resection bladder tumor surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA Class1,2
Patients are candidates for bladder tumor resection through the urethra
Exclusion criteria:
Kidney failure with GFR <45 ml / min
Heart failure, heart rhythm disturbances, calcium and magnesium plasma disorders, hemodynamic disorders
Taking drugs that affect calcium and magnesium transfer in muscle
Musculoskeletal Diseases
Hemodynamic instability
Taking medications that affect the transmission of neuromuscular messages
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method. In this study, 4 blocks will be used and with the help of web randomization, 13 random 4 blocks will be created for the sample size of 52 people. Then, in addition to block randomization, a special code was assigned to each random sequence created to prevent the random process from leaking. This code is a specific code for each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the therapist and the participants were kept blind about the allocation of intervention groups and drug doses.
Placebo
Not 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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-06-15, 1399/03/26
Ethics committee reference number
IR.KUMS.REC.1399.253
Health conditions studied
1
Description of health condition studied
Bladder tumor
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Muscular pain
Timepoint
The first 24 hours after surgery
Method of measurement
Using the NRS method (numerically from 0 to 10)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive an intravenous infusion of Saxil Neil Colin bolus1 mg/kg over 10 minutes.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 40 mg/kg intravenous magnesium sulfate as an infusion over 10 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Shayesteh Rezaei
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
shayesteh.rezaeii@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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
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
Shayesteh Rezaei
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
shayesteh.rezaeii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elham Siyakamari
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
e.siahkamari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shayesteh Rezaei
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
shayesteh.rezaeii@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
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
4 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
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 25-day timeframe