Laryngospasm is common after adenotonsillectomy. For laryngospasm relief various techniques are suggested.
The aim of this study is the clinical effectiveness of magnesium sulfate with placebo. For this reason in a patient – observer blind randomized clinical trial 70 patients from 3 to 12 years old that scheduled for Adenotonsillectomy will seclect (after explaning the process of the trial and written informed consent obtained from participants ) then they will receive magnesium sulfate 15mg/kg and second group will receive saline normal 0.9% with the same volume within 20 minutes. Cough and laryngospasm and oxygen saturation will be recorded after extube in 0,15 and 30 minutes in post Anesthesia care unit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207181138N10
Registration date:2012-08-16, 1391/05/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-16, 1391/05/26
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Research Vice
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey on the effects of intravenous sulfate magnesium on laryngospasm after elective Adenotonsillectomy surgery in children
Public title
The effects of Sulfate Magnesium on Children's Laryngospasm
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for elective Adenotonsillectomy surgery (3 – 12yr); ASA class I, II
Exclusion criteria:
Emergency surgery, re-operation, history of respiratory, cardiac, renal disease, upper respiratory tract infection, myasthenia gravis, history of difficult intubation or extubation, supra glottitis ,history of the known seasitivity to magnesium sulfate, heart block ,hypotesion.
Age
From 3 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Siadati st.
City
Rasht
Postal code
Approval date
2012-05-14, 1391/02/25
Ethics committee reference number
671
Health conditions studied
1
Description of health condition studied
Laryngospasm
ICD-10 code
Acute lary
ICD-10 code description
oedematous
Primary outcomes
1
Description
Laryngospasm
Timepoint
minute of 0- 15- 30 & 60
Method of measurement
Oxygen Saturation
Secondary outcomes
1
Description
Cough
Timepoint
Minutes of 0- 15-30 & 60
Method of measurement
Four degree scale
Intervention groups
1
Description
Magnesium sulfate 15mg/kg in 20 minutes
Category
Treatment - Drugs
2
Description
Saline normal 0.9% with the same volume of drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Susan Komaii
Street address
Siadati St.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
so_haddadi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Sudabeh Haddadi
Position
Assistant Professorof Anesthesia
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahrivar St.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
so_haddadi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)