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Comparison the effect of combined of (bupivacaine + magnesium sulfate) with combined (pethidine + magnesium sulfate) and sole pethidine in spinal anesthesia on effect of duration and hemodynamic changes in patients under Lower Limb orthopedic surgery

Protocol summary

Study aim
Determining the effect of combination (bupivacaine + magnesium sulfate) with the combination (pethidine + magnesium sulfate) and alone on the duration of action and hemodynamic changes in patients undergoing orthopedic surgery with lower limb fractures
Design
Clinical trial with control group, block randomization, thirty patients in each group with parallel groups, double blinded
Settings and conduct
This study will be conducted at Golestan University of Medical Sciences in the operating room of Gorgan 5th Azar Hospital in 2020. Patients in 4 control groups will receive medication interventions. After the injection, the sensation block time will be recorded using a blunt needle and the motion block will be recorded using the bromage scale and the duration of the sensory and motor block and possible hemodynamic changes in patients. I in order to perform the method of blinding the patient, the statistical evaluator and analyst will not be aware of the type of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patient with lower limb fracture candidate for orthopedic surgery which can be performed under spinal anesthesia 2- Signing a consent form 3- Class 1 or 2 ASA physical condition 4- Age 18-60 years old 5- Ellecitve surgery Exclusion criteria: 1- High intracranial pressure 2. Infection in injection site 3- Impossible of proper position
Intervention groups
Group A : 100 mg of magnesium sulfate with bupivacaine at a dose of 10 mg).  Group B :100 mg of magnesium sulfate with pethidine at a dose of 1 mg / kg group C: Pethidine 1 mg / kg alone group D: bupivacaine with a dose of 10 mg alone
Main outcome variables
duration of anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170413033408N3
Registration date: 2020-06-11, 1399/03/22
Registration timing: prospective

Last update: 2020-06-11, 1399/03/22
Update count: 0
Registration date
2020-06-11, 1399/03/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 9891
Email address
dr.mojaveraghili@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of combined of (bupivacaine + magnesium sulfate) with combined (pethidine + magnesium sulfate) and sole pethidine in spinal anesthesia on effect of duration and hemodynamic changes in patients under Lower Limb orthopedic surgery
Public title
Comparison of the effect of drug combination in lower back anesthesia on duration of effect and changes in heart rate and blood pressure in patients undergoing orthopedic surgery with lower limb fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with lower limb fracture candidate for orthopedic surgery which can be performed under spinal anesthesia Signing a consent form Class 1 or 2 of the physical condition of the American Anesthesia Association ASA Age range 18-60 years Elective surgery
Exclusion criteria:
High intracranial pressure Infection in site of injection Impossible of proper position History of allergy with bupivacaine or pethidine
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants who have the conditions to enter the study, using the random blocks method, these people will be assigned to four groups A, B, C, D. According to the sample size of 30 in the groups, all four blocks of letters A, B, C and D are considered and thirty blocks will be randomly selected; In a random process, a sequence of one hundred and twenty letters A, B, C, D will be created, then this sequence will be numbered from one to 120 numbers. Numbers one to 120 will be placed in a bag, and the researcher will randomly select one of the numbers for each eligible person in the present study, based on the selected number in one of the letters A, B, C, D (respectively to Combination groups (Bupivacaine + Magnesium Sulfate), Combination ( Pethdine + Magnesium Sulfate), Pethdine and Bupivacaine will be done.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, in order to perform the method of blinding the patient, the statistical evaluator and analyst will not be aware of the type of groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences Ethics Committee
Street address
Gorgan-sari road 4th kilometer,Golestan University of Medical Science
City
Gorgan
Province
Golestan
Postal code
4917763681
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.GOUMS.REC.1398.400

Health conditions studied

1

Description of health condition studied
Lower Limb fracture
ICD-10 code
M89.9
ICD-10 code description
Disorder of bone, unspecified

Primary outcomes

1

Description
The duration of the anesthetic effect
Timepoint
The duration of anesthesia will be recorded every minute immediately after intravenous injection until the onset of sensory block and every 5 minutes until sensory level stabilization.
Method of measurement
Using a blunt needle and register in the checklist

2

Description
Hemodynamic change
Timepoint
Hemodynamic changes in the operating room will be measured every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery. The recovery room will record every 15 minutes until recovery criteria are met..
Method of measurement
Hemodynamic criteria (heart rate, systolic, diastolic, and mean arterial blood pressure (MABP), arterial oxygen saturation) of the patient will be measured by Saadat monitoring.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A patients will receive Intrathecal magnesium sulfate with 100 mg bupivacaine at a dose of 10 mg.
Category
Treatment - Drugs

2

Description
Intervention group: Group B will be patients receiving 100 mg of Intrathecal magnesium sulfate with pethidine at a dose of 1 mg / kg .
Category
Treatment - Drugs

3

Description
Intervention group: group C Petdin 1 mg / kg will be injected into the spinal cord
Category
Treatment - Drugs

4

Description
Control group: Group D Bupivacaine will be injected Intrathecal at a dose of 10 mg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan 5 Azar Educational and Medical Center
Full name of responsible person
Dr.Babak mojaver aghili
Street address
Gorgan-Sari road 4th kilometers, Golestan University of Medical Sciences, School of Medicine - Anesthesiology Department
City
Gorgan
Province
Golestan
Postal code
2534756984
Phone
+98 17 3334 2067
Email
dr.mojaveraghili@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Honarvar
Street address
Golestan University of Medical Sciences, Deputy of research and technology-Gorgan-Gorgan-Sari 4th kilometer,
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3566
Fax
+98 17 3245 1657
Email
Honarvar@gous.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
dr Babak Mojaver Aghilli
Position
Anesthesiologist, Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan University of Medical Sciences.School of Medicine, Department of Anesthesiology, Gorgan, Shastkola road
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3566
Email
drbabaka35@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed babak Mojaveraghili
Position
Assistant Professor - Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Medical school, anesthesia group, Gorgan - Sari 4th kilometers
City
Gorgan
Province
Golestan
Postal code
491776381
Phone
+98 17 3115 2566
Fax
+98 17 3232 6072
Email
dr.mojaveraghili@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
ُSeyed Babak Mojaver Aghili
Position
Assistant Professor - Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Medical school, anesthesia department,Gorgan-Sari raod 4th kilometers
City
Gorgan
Province
Golestan
Postal code
491776381
Phone
+98 17 3115 3566
Fax
+98 17 3232 6072
Email
dr.mojaveraghili@goums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Since 2021
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No manipulation, mentioning the data reference
From where data/document is obtainable
Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Golestan University of Medical Sciences, Deputy of Research and Technology, Gorgan, Golestan, Iran, Gorgan, 4 km, Sari,
What processes are involved for a request to access data/document
sending an email, complete the personal and professional characteristics with documentation
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