To evaluate the efficacy of magnesium sulfate in difficult exposure direct laryngoscopy
Design
non-randomized clinical trial
Settings and conduct
In patients who candidate for direct laryngoscopy with difficult exposure low intravenous infusion (in 1 minute by microset) of magnesium sulfate(50 mg/kg in 50 cc normal saline) and after 5 minutes re-evaluate the laryngeal difficulty exposure and recording of pulse rate and blood pressure.statistical analysis was done with SPSS version 21 and also descriptive and analytical methods.
Participants/Inclusion and exclusion criteria
inclusion criteria: ّAdult patients above 18 years old with difficult laryngeal exposure according to Cormack-Lehane criteria
exclusion criteria:cardiovascular diseases ,arrhythmia or any underlying diseases that is contraindicated in magnesium sulfate using according to anesthesiologist evaluation
Intervention groups
Prescription of magnesium sulfate in patients with difficult laryngeal exposure
Main outcome variables
laryngeal exposure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051865N1
Registration date:2021-09-08, 1400/06/17
Registration timing:prospective
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Kamyar Iravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3629 1478
Email address
iravanika@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the Efficacy of magnesium sulfate in feasibility of direct laryngoscopy in difficult exposure patients, a non-randomized trial
Public title
To evaluate the Efficacy of magnesium sulfate in laryngoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with difficult airway according to cormack-Lehane criteria
Exclusion criteria:
cardiovascular diseases and arrhythmia and any underlying medical condition that contraindicated to magnesium sulfate using according to anesthesiologist evaluation
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Shiraz University of Medical Sciences
Street address
department of otolaryngology, Khalili hospital,kalili St.
City
shiraz
Province
Fars
Postal code
7193616641
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
IR.SUMS.MED.REC.1400.127
Health conditions studied
1
Description of health condition studied
difficult exposure direct laryngoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
laryngeal exposure
Timepoint
Before intervention, After intervention
Method of measurement
According to Cormack-Lehane criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Slow intravenous infusion (in 1 minute by microset) of magnesium sulfate(50 mg/kg in 50 cc normal saline) and after 5 minutes re-evaluate the laryngeal difficulty exposure and recording of pulse rate and blood pressure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room-Khalili hospital
Full name of responsible person
kamyar iravani
Street address
khalili hospital-khalili st.
City
shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
iravanika@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
ZAND Ave, Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
kamyar iravani
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
khalili st.
City
shiraz
Province
Fars
Postal code
7193616641
Phone
0091716291478
Email
iravanika@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
kamyar iravani
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
department of otolaryngology,khalili hospital,khalili st.
City
shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
iravanika@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
kamyar iravani
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
laryngeal diseases
Street address
department of otolaryngology,khalili hospital,khalili St.
City
shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
iravanika@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Part of the data can be shared after unidentified
When the data will become available and for how long
6 months after publication
To whom data/document is available
Interested researchers and clinicians in this field
Under which criteria data/document could be used
Using for research and clinical works
From where data/document is obtainable
Research and technology deputy
What processes are involved for a request to access data/document
Sending an Email to research and technology deputy.