Comparative study of the effect of adding magnesium, neostigmine and fentanyl to ropevacaine on the properties of motor sensory block in lower extremity surgery under spinal anesthesia
Comparative study of the effect of adding magnesium, neostigmine and fentanyl to ropevacaine on the properties of motor sensory block in lower extremity surgery under spinal anesthesia
Design
Clinical trial without control group with parallel, randomized, phase 3 groups per 100 patients
Settings and conduct
This study is performed in Kashani Hospital in Isfahan. Patients are divided into two groups. The first group receives magnesium, neostigmine, and fentanyl, as well as ropevacaine, during anesthesia. The second group receives only rupee and vaccine. Patients' pain will be measured at the desired times.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 65 years, patient agreement with spinal anesthesia, lower limb surgery. Exclusion criteria: presence of infection at the injection site, coagulation disorders, high intracranial pressure, neurological disease.
Intervention groups
Intervention group 1: Patients in this group are candidates for elective lower extremity surgery under spinal anesthesia and receive magnesium, neostigmine and fentanyl in addition to ropevacaine during anesthesia. Patients' pain is measured by a visual analog scale questionnaire for 1 hour, 3 hours and 6 hours after surgery and during surgery and will be compared with another group. Intervention group 2: Patients in this group are candidates for elective lower extremity surgery under spinal anesthesia and receive rupee and cocaine during anesthesia. Patients' pain is measured by a visual analog scale questionnaire for 1 hour, 3 hours and 6 hours after surgery and during surgery and will be compared with another group.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N11
Registration date:2021-03-03, 1399/12/13
Registration timing:prospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-20, 1400/01/31
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of adding magnesium, neostigmine and fentanyl to ropevacaine on the properties of motor sensory block in lower extremity surgery under spinal anesthesia
Public title
The effect of magnesium, neostigmine and fentanyl and ropevacaine on the characteristics of motor sensory block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Patient agrees to spinal anesthesia
Lower limb surgery
Exclusion criteria:
Infection at the injection site
Existence of coagulation disorders
High intracranial pressure
Having a neurological disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2020-09-04, 1399/06/14
Ethics committee reference number
IR.MUI.MED.REC.1399.460
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
1 hour, 3 hours and 6 hours after surgery
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group are candidates for elective lower extremity surgery under spinal anesthesia and receive magnesium, neostigmine and fentanyl in addition to ropevacaine during anesthesia. Patients' pain is measured by a visual analog scale questionnaire for 1 hour, 3 hours and 6 hours after surgery and during surgery and will be compared with another group.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group are candidates for elective lower extremity surgery under spinal anesthesia and receive rupee and cocaine during anesthesia. Patients' pain is measured by a visual analog scale questionnaire for 1 hour, 3 hours and 6 hours after surgery and during surgery and will be compared with another group.
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Rahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Rahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Rahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@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 people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.