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Comparison of the effect of magnesium sulfate and bupivacaine on dexmedetomidine and bupivacaine in the epidural block of patients undergoing orthopedic surgery

Protocol summary

Study aim
According to the results of this study, it is possible to choose a drug with appropriate efficiency and minimal harm as an additive to bupivacaine in terms of duration of sensitivity of sensory and motor block, time of block onset and side effects in epidural anesthesia for lower limb surgery.
Design
A double-blind, randomized, phase 3 clinical trial on 50 patients, the random permutation block method is used for randomly assigning patients to study groups, and finally, the data collected for data analysis from + tests ( If necessary, Mann-Whitney) and chi-square test will be used, and if necessary, linear regression and logistic regression will be used for multivariate data analysis, and all analyzes will be done using spss version 20 software.
Settings and conduct
Upon entering the operating room, the research is explained to all the participants and they are assured about the confidentiality of the information, then after obtaining permission from the patients, a written consent form is obtained to enter the study using the information in the file. Medicine, medical history of patients is collected.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients aged 18-60 years with anesthesia risk ASA I, II candidates for lower limb orthopedic surgery, exclusion criteria include patients with local infection at the site of epidural block, patients who are allergic to the study drugs, patients who during The operation requires receiving analgesia, patients whose epidural block failed and were subjected to general anesthesia.
Intervention groups
BD group underwent epidural block with bupivacaine and dexmedetomidine and BM group underwent epidural block with bupivacaine and magnesium sulfate.
Main outcome variables
Visual Analogue Scale (VAS) Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231114060049N1
Registration date: 2023-11-14, 1402/08/23
Registration timing: registered_while_recruiting

Last update: 2023-11-14, 1402/08/23
Update count: 0
Registration date
2023-11-14, 1402/08/23
Registrant information
Name
nelya reza gholi dehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 613 0524
Email address
nelya.dehkordi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-14, 1401/12/23
Expected recruitment end date
2024-05-12, 1403/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of magnesium sulfate and bupivacaine on dexmedetomidine and bupivacaine in the epidural block of patients undergoing orthopedic surgery
Public title
Comparing the effect of magnesium sulfate with dexmedetomidine in epidural block with bupivacaine half percent
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 year old patients with anesthesia risk ASA I,II candidates for lower limb orthopedic surgery
Exclusion criteria:
Patients with local infection at the site of epidural block Patients who are allergic to the study drugs Patients who need to receive analgesia during surgery Patients whose epidural block failed and underwent general anesthesia
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the patients are randomized and based on the quadruple permutation block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the doctor and the person who fills in the questionnaire do not know how people are placed in the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan hospital, Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan hospital,Golestan Ave,Golestan town
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.204

Health conditions studied

1

Description of health condition studied
orthopedic surgery
ICD-10 code
Y83.1
ICD-10 code description
Surgical operation with implant of artificial internal device as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Primary outcomes

1

Description
Pain
Timepoint
After the operation, from the time the level of anesthesia reached T12 to the time of the first application of anesthesia, it was recorded every 30 minutes.
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
blood pressure
Timepoint
It is recorded immediately after the block and every 5 minutes in the first 30 minutes and every 15 minutes until the end of the sensory and motor block.
Method of measurement
Reading from the monitoring device

2

Description
It is recorded immediately after the block and every 5 minutes in the first 30 minutes and every 15 minutes until the end of the sensory and motor block.
Timepoint
It is recorded every 15 minutes until the end of the sensory and motor block.
Method of measurement
Reading from the monitoring device

3

Description
Oxygen Saturation (sat O2)
Timepoint
It is recorded immediately after the block and every 5 minutes in the first 30 minutes and every 15 minutes until the end of the sensory and motor block.
Method of measurement
Reading from the monitoring device

4

Description
Length of effect of sensory block
Timepoint
It is measured every 15 minutes
Method of measurement
Until the sensory level reaches L5.

5

Description
Engine block effect length
Timepoint
The first 30 minutes are recorded every 5 minutes and then every 30 minutes until the Modified Bromage Scale number reaches zero.
Method of measurement
Time

6

Description
The first time the medicine is needed after the operation
Timepoint
The first time when the patient needs pain medication after the operation
Method of measurement
Time

Intervention groups

1

Description
Intervention group: BD group is subjected to epidural block with bupivacaine and dexmedetomidine.
Category
Treatment - Drugs

2

Description
Intervention group: BM group are subjected to epidural block with bupivacaine and magnesium sulfate.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating room of Golestan Hospital
Full name of responsible person
Reza Akhondzadeh
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 113 5201
Email
akhondzadeh-r@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
University of medical science, Golestan street, Golestan town، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 613 0524
Email
nelya.dehkordi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 113 5201
Email
akhondzadeh-r@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 113 5201
Email
akhondzadeh-r@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 113 5201
Email
akhondzadeh-r@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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