Comparison of two different doses of Magnesium Sulfate on prevention of pain during Etomidate injection
Design
The clinical trial includes three groups, has a control group, three-way blinded, randomized, phase 3 . It is used for randomizating from Random Allocation Software on 90 sicks.
Settings and conduct
This thrple blind clinical trial study is conducted during 2022-2023 in Al-Zahra Hospital of Isfahan. 90 patients who are candidates for anesthesia with Etomidate are randomly divided into three groups. The groups are respectively received 0.750 mg of magnesium sulfate, 1 gram of magnesium sulfate and lidocaine, and the pain during the injection of Etomidate is evaluated and compared between the three groups. In this study, the patients, the researcher and the outcome assessor are blinded.
Participants/Inclusion and exclusion criteria
In this study, patients who are candidates for elective surgery who are candidates for anesthesia with etomidate and have no history of cardiovascular and neuromuscular diseases, pregnancy and liver and kidney diseases are included in the study.
Intervention groups
Intervention group 1: patients receiving 750 mg magnesium sulfate injection
Intervention group 2: patients receiving 1 gram of magnesium sulfate injection
Control group: patients under lidocaine injection
Main outcome variables
Determining og effective dose of magnesium sulfate for prevent pain caused by atomiditis injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090129001615N6
Registration date:2023-02-21, 1401/12/02
Registration timing:prospective
Last update:2023-02-21, 1401/12/02
Update count:0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Azim Honarmand
Name of organization / entity
Alzahra hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
honarmand@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two different doses of Magnesium Sulfate on the prevention of pain during Etomidate injection
Public title
The effect of two different doses of Magnesium Sulfate on prevention of pain during Etomidate injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. All patients who need to anesthesia With Etomidate Aged 18-65 years with ASA (American Society of Anesthesiologists) grade:1 or 2
2. No History of allergy to Magnesium
3. candidate for Elective Surgery
Exclusion criteria:
1. Patients with neuromuscular disease
2. Patients who have Difficulty Communicating
3. Myocardial Ischemia
4. Cardiac Arrhythmia
5. Seizure
6. Endocrine and Metabolic Diseases
7. Mental Disorders
8. Severe Neurological Disease
9. People without a vein in the back of the hand
10. Pregnancy
11. Liver and kidney diseases
12. Thrombophlebitis
13. Chronic pain
14. pancreatic disorders
15. Patients receiving sedative or analgesic drugs
16. Substance abusers
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Because sample volume is low and we want to figure on the balance of the number of people in each group ,We use the permuted(block) randomization method what one of types of restricted randomization method is .
In this order that has been made of 15 block s of 6 consisting on 2 numbers out of 2, A numbers out of B and 2 numbers out of C.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding is done as follows: the study drugs are named by the nurse as A and B codes. Patients, researchers and data collectors are unaware of the study group. The studied drugs are injected with the same syringes in terms of volume and color, and therefore the patients will not have any information about the injected drugs.
Placebo
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
Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.MUI.MED.REC.1401.058
Health conditions studied
1
Description of health condition studied
Pain due to Etomidate injection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity during Etomidate injection
Timepoint
Every minute until 10 minutes after Etomidate injecting
Method of measurement
Pain intensity is evaluated with using a 4-point Likert scale including: 0=no pain, 1=mild (pain expressed in response to the patient's question and without symptoms), 2=moderate (pain expressed in response to the patient's question) can be expressed along with the symptoms of the disease or pain spontaneously without asking the patient), 3=severe (a strong facial response or a response accompanied by arm withdrawal or facial grimacing) is measured.
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every minute after Etomidate injection up to 10 minutes
Method of measurement
Pulse oximeter
2
Description
Heart rate
Timepoint
Every minute after Etomidate injection up to 10 minutes
Method of measurement
Pulse oximeter
Intervention groups
1
Description
Intervention group 1: injection of 750 mg of magnesium sulfate 30 seconds before the injection of etomidate
Category
Prevention
2
Description
Intervention group 2: injection of 1 gram of magnesium sulfate 30 seconds before the injection of etomidate
Category
Prevention
3
Description
Control group: injection of 1 mg of lidocaine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Azim Honarmand
Street address
Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
honarmand@med.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
gh_askari@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
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 1236 1594
Email
honarmand@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 1236 1594
Email
honarmand@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 0048
Fax
+98 31 1236 1594
Email
honarmand@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to the government organization and it is not possible to share it.