Protocol summary

Study aim
The effect of magnesium sulfate on the prevention of postoperative sore throat in patients undergoing FESS
Design
In this study, 90 patients undergoing simple randomized endoscopic sinus surgery were enrolled in a double-blind clinical trial with 45 parallel groups.
Settings and conduct
This study was performed at Imam Khomeini Hospital in Ahvaz. The syringes are pre-prepared, numbered, and coated by an anesthetic technician who has not been involved in the study for blindness.To be a double-blind study, the designer, patient, and registrant of the results will be unaware of the type of injection solution. In recovery, 2, 6, and 12 hours later, the severity of the sore throat (based on the 0-10 criterion) and the incidence of cough is recorded.
Participants/Inclusion and exclusion criteria
Patient aged 18 to 60 years Class I and II by Classification of American Anesthesiology No pre-operative sore throat Upper airway infectious disease, Not having a cold, Not a smoker, No liver or kidney failure, Not to be pregnant, Magnesium insensitivity, Should not have been attempted for endotracheal intubation more than once, Not being in grade 3 or more, No chronic use of calcium blockers or magnesium
Intervention groups
The patient under general anesthesia will be injected with fentanyl 2μg/kg, midazolam 0.02 mg/kg and propofol 2mg/kg and to facilitate intratracheal endotracheal intubation 0.5 mg / kg. Atracurium 0.15 mg / kg is used to continue muscle relaxation if the patient returns.The laryngoscopy will be performed by an anesthesiologist with a metallic laryngoscope No. 3-4. Male patients with endotracheal tube with an inner diameter of 8 and female patients with with an inner diameter of 7.5 mm will be intubated. After intubation, 40 mg / kg magnesium sulfate is injected for 20 minutes at the same volume of normal saline for the control group.
Main outcome variables
Sore throat Cough

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191030045272N1
Registration date: 2019-11-11, 1398/08/20
Registration timing: retrospective

Last update: 2019-11-11, 1398/08/20
Update count: 0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Sara Adarvishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3377 7966
Email address
adarvishi-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2019-03-11, 1397/12/20
Trial completion date
2019-03-16, 1397/12/25
Scientific title
The Effect of Magnesium Sulfate in Prevention of Sore Throat after Surgery in Patients Undergoing Endoscopic Sinus Surgery
Public title
The Effect of Magnesium Sulfate in Prevention of Sore Throat after Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They were classified Class I and II according to the American Anesthesia Association. To undergo FESS surgery at Imam Khomeini Hospital in Ahwaz in 1997-96.
Exclusion criteria:
Consume calcium blockers or magnesium chronically. Malampati have grade 3 and above. Endotracheal intubation has been attempted more than once. Allergic to magnesium. To be pregnant. Have liver and kidney failure. To be smokers. They are cold. Have upper airway infectious disease. Have a history of pre-operative sore throat.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who are candidates for endoscopic sinus surgery will be selected by census according to inclusion criteria and will be randomly treated using packages containing code A (magnesium) and B (placebo)
Blinding (investigator's opinion)
Double blinded
Blinding description
To be a double-blind study, the designer, patient, and registrant of the results will be unaware of the type of injection solution.   The syringes are pre-prepared, numbered, and coated by an anesthetist who was not involved in the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahvaz jundishapur University of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.AJUMS.REC.1396.946

Health conditions studied

1

Description of health condition studied
Sore throat
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis, unspecified

Primary outcomes

1

Description
Sore throat
Timepoint
In the post-anesthesia care unit and after full consciousness
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Cough
Timepoint
In recovery, 2, 6 and 12 hours after surgery
Method of measurement
observation

Intervention groups

1

Description
Intervention group: After intubation, 40 mg / kg magnesium sulfate is injected for 20 minutes.
Category
Prevention

2

Description
Control group: After intubation patients will be given normal saline for 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomeini Hospital
Full name of responsible person
Ahmadreza Mohtadi
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
Mohtadi_ar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice Chancellor For Research of Ahvaz Jundishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Mohtadi_ar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur 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
Mohammadreza Shafaf
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shaffaf.MR@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Shafaf
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Shaffaf.MR@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Shafaf
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009861333738383
Email
Shaffaf.MR@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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