Protocol summary

Summary
Sorethroat is a common problem after general anesthesia. It may be seen after using tracheal tube, laryngeal mask air way or even anesthesia face mask. In this study, the efficacy of intracuff dexamethasone, intracuff magnesium sulfate & placebo on sorethroat were compared. This is a randomized double blind clinical trial among 90 patients who are candidate of general anaesthesia with tracheal intubation. The patients were assigned randomly to 3 groups, each group consisted of 3o patients. Tracheal tube cuff at first group was filled with a solution of 16 mg Dexamethasone. Second group tracheal tube cuff was filled with 50 mg/kg Magnesium sulfate solution & the tracheal tube cuff at 3rd. group was filled with air. The patients were evaluated after recovery, at the end of op. day & on the morning after surgery for sorethroat & its sevsrity(according to VAS).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112268531N1
Registration date: 2012-02-07, 1390/11/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-07, 1390/11/18
Registrant information
Name
Ladan Ansari
Name of organization / entity
Islamic Azad University, Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8876 4030
Email address
lansari@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad Univresity, Tehran Medical Branch
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intracuff Dexamethasone & Magnesium sulfate efficacy on frequency & severity of post- intubation sorethroat
Public title
Intracuff Dexamethasone & Magnesium sulfate efficacy on frequency & severity of post- intubation sorethroat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age>16 yr; ASA class 1 or 2; no URI infection or sorethroat at the time of surgery; no possibility of difficult air way; no candidate of surgery on air way; candidate of general anesthesia & tracheal intubation; no contraindication for receiving steroids or Magnesium sulfate . Exclusion criteria: intraopertion pharyngeal packing; intraopertion NG tube placement.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Islamic Azad University,Tehran Medical Branch Ethics committee
Street address
Islamic Azad University, Tehran Medical Branch, Zargande, Shariati St.
City
Tehran
Postal code
19395/1495
Approval date
2011-01-15, 1389/10/25
Ethics committee reference number
8910- 1001

Health conditions studied

1

Description of health condition studied
post tracheal intubation sorethroat
ICD-10 code
Y70
ICD-10 code description
Anaesthesiology devices associated with adverse incidents

Primary outcomes

1

Description
sorethroat
Timepoint
After recovery, at the end of operation day, on the morning of the first post operation day
Method of measurement
questionare (VAS method)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention1: intracuff Desxamethasone, 16 mg, during intraoperation intubation period.
Category
Prevention

2

Description
Intervention2: intracuff Magnesium sulfate, 50 mg/kg , during intraoperation intubation period.
Category
Prevention

3

Description
control: intracuff air, during intraoperation intubation period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Booali Hospital
Full name of responsible person
Ladan Ansari, Assistant Professor in Anaesthesiology
Street address
Damavand Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Tehran Medical Branch, Vice chansellor for research
Full name of responsible person
Dr. Seyedshahabedin Mohseni
Street address
Islamic Azad University,Tehran Medical Branch, Zargande, Shariati ST. ,Tehran Medical Branch
City
Tehran
Grant name
2
Grant code / Reference number
5
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Tehran Medical Branch, Vice chansellor for research
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
Islamic Azad University, Tehran Medical Branch, Booali Hospital
Full name of responsible person
Ladan Ansari
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Zargande, Shariati st.
City
Tehran
Postal code
19395/1495
Phone
+98 21220066609
Fax
+98 21 2200 8049
Email
Naghipour@iautmu.ac.ir
Web page address
www.iautmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch, Booali Hospiital
Full name of responsible person
Ladan Ansari
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Zargande, Shariati st.
City
Tehran
Postal code
19395/1495
Phone
+98 21220066609
Fax
+98 21 2200 8049
Email
Naghipour@iautmu.ac.ir
Web page address
www.iautmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Tehran Medical Branch, Booali Hospital
Full name of responsible person
Ladan Ansari
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Zagande - Shariati st.
City
Tehran
Postal code
19395/1496
Phone
+98 21220066609
Fax
+98 21 2200 8049
Email
Naghipour@iautmu.ac.ir
Web page address
www.iautmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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