Comparison of the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding and postoperative edema and ecchymosis in rhinoplasty
Comparison of the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding and lack of banana hockey after rhinoplasty
Design
A double-blind clinical trial, in two groups of magnesium sulfate and labetalol, with parallel, randomized, phase 3 groups on 60 patients, PASS11 software is used for randomization.
Settings and conduct
The project site is Amir Al-Momenin Hospital in Rasht. Blindness is such that only the anesthesiologist is aware of the type of drug being used and all patients, researchers and surgeons are unaware of the patient's exposure. In the sulfate group, 30 to 50 mg / kg intravenous magnesium sulfate is given before induction of anesthesia, and 10 to 20 mg / kg intravenous magnesium sulfate is infused during surgery. In the labetalol group, the infusion of labetalol is 1 mg / min intraoperatively (limit less than 300 mg).
Participants/Inclusion and exclusion criteria
The statistical population includes people who undergo rhinoplasty surgery in Amir Al-Momenin Hospital in Rasht at a specific time. Inclusion criteria include age over 18 and consent to participate in the study
Intervention groups
The aim of this clinical trial was to compare the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding, edema and ecchymosis after rhinoplasty in two groups of magnesium sulfate and labetalol.
Main outcome variables
Bleeding during surgery; Edema and ecchymosis after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211108053010N1
Registration date:2022-05-28, 1401/03/07
Registration timing:registered_while_recruiting
Last update:2022-05-28, 1401/03/07
Update count:0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Shaghayegh Rezaeekia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3346 9321
Email address
shaghayeghrezaeekia1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding and postoperative edema and ecchymosis in rhinoplasty
Public title
Comparison of the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding and postoperative edema and ecchymosis in rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
over 18 years old
consent to participate in the study
Exclusion criteria:
history of hypertension
peripheral vascular problems
renal, hepatic or hematologic disorders
pregnancy
obesity
diabetic neuropathy
uncontrollable hypertension
previous treatment with any antihypertensive drug, opioid or anticoagulant
magnesium supplementation
consumption Chronic drug
drug use such as aspirin
allergy to magnesium sulfate, drugs or other drugs under study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly divided into two groups using PASS11 software. Random allocation was performed by Efron method with one thousand repetitions and due to this method, an equal number of samples in each block are placed in two groups of magnesium sulfate and labetalol. In randomization, equal chances are provided for all samples to be in one of the two groups. The researcher does not interfere in determining the group for the samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness is such that only the anesthesiologist is aware of the type of drug being used and all patients, researchers and surgeons are unaware of the patient's reception.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Farahabad Street
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.MAZUMS..REC.1401.13695
Health conditions studied
1
Description of health condition studied
Bleeding during rhinoplasty
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Edema and ecchymosis after rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of bleeding during the operation
Timepoint
End of operation
Method of measurement
Measure lost blood by examining gases and suction
2
Description
The rate of ecchymosis
Timepoint
24 hours and one week after surgery
Method of measurement
Standard tool for scoring degree of ecchymosis
3
Description
The amount of edema
Timepoint
24 hours and one week after surgery
Method of measurement
Standard tool for scoring degree of edema
Secondary outcomes
1
Description
Sore throat
Timepoint
Postoperatively and 24 hours after surgery
Method of measurement
4 degree scale of sore throat
2
Description
headache
Timepoint
24 hours after surgery
Method of measurement
Question
3
Description
Orthostatic hypotension
Timepoint
24 hours after surgery
Method of measurement
Barometer
4
Description
Respiratory depression
Timepoint
24 hours after surgery
Method of measurement
See the number of breaths per minute
5
Description
surgeon consent
Timepoint
After surgery
Method of measurement
Boezaart criteria
Intervention groups
1
Description
Intervention group: In the sulfate group, 30 to 50 mg / kg intravenous magnesium sulfate is given before induction of anesthesia, and 10 to 20 mg / kg intravenous magnesium sulfate is infused during surgery. Magnesium sulfate is prepared from Shahid Ghazi Pharmaceutical Company, Tabriz, Iran.
Category
Prevention
2
Description
Intervention group: In the labetalol group, the infusion of labetalol is 1 mg / min intraoperatively (limit less than 300 mg). Labetalol is produced by Restagen Daru Pharmaceutical Company, Tehran, Iran.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-momenin Hospital, rasht
Full name of responsible person
Hooshang akbari
Street address
17 Shahrivar Street
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8307
Email
amiralmomenin@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences
Street address
Moalem Square
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
70
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
Mazandaran University of Medical Sciences
Full name of responsible person
Shaghayegh Rezaeekia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Mehr Town, 103 Mehr Alley, Block 42, Unit 11
City
Rasht
Province
Guilan
Postal code
4196936484
Phone
+98 13 3346 9321
Fax
Email
shaghayeghrezaeekia1375@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Farahabad Street
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
0098 11 330440001
Email
hooshangakbari48@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shaghayegh Rezaeekia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Mehr Town, 103 Mehr Alley, Block 42, Unit 11
City
Rasht
Province
Guilan
Postal code
4196936484
Phone
+98 13 3346 9321
Fax
Email
shaghayeghrezaeekia1375@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
It is possible to share all data by not mentioning the names of people and protecting the privacy of people.
When the data will become available and for how long
After publishing the related article
To whom data/document is available
Researchers of university centers
Under which criteria data/document could be used
After obtaining a license and approval from the Vice Chancellor for Research of Mazandaran University of Medical Sciences
From where data/document is obtainable
Refer to Shaghayegh Rezaee Kia project manager with email address: shaghayeghrezaeekia1375@gmail.com and Phone number: 09386589690
What processes are involved for a request to access data/document
After obtaining a license and approval from the Vice Chancellor for Research of Mazandaran University of Medical Sciences and referring to the project manager