Survey and Comparison of intravenous and intra-cuff Hydro cortisone on the severity of sore throat, cough and nausea after tracheal intubation during general anesthesia in distal limb fractures
Objective: To determine the effect of intravenous and intra-cuff hydrocortisone on the severity of sore throat, cough and nausea after general anesthesia using endotracheal tube
Design: A randomized triple-blind (patient. data collector, data analyzer)
Study population: patients with distal limb fractures
Setting and conduct: With block random allocation, patients will be included in three groups: A, B and C. After intubation, in group A, endotracheal tube cuff is filled with 100 mg hydrocortisone diluted with 5-10 ml distilled water and in group B, 100 mg diluted hydrocortisone is injected IV, and for group C, cuff is filled by 5-10 ml distilled water (routine).
Main inclusion criteria: ASA class 1 and 2 anesthesia; lack of drug addiction; aged between 60-18 years; no sore throat or hoarseness prior to surgery
Main exclusion criteria: Acute upper respiratory infections; the history of steroids and narcotics use in a week before surgery
Sample size: 135 patients
Interventions: 100 mg hydrocortisone diluted with 5-10 ml of distilled water inside the endotracheal tube cuff for group A, 100 mg diluted hydrocortisone IV for group B, and 5-10 ml of distilled water inside the cuff (routine) for group C.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603033064N3
Registration date:2016-07-20, 1395/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-20, 1395/04/30
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research (Research and Technology), Shahroud University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey and Comparison of intravenous and intra-cuff Hydro cortisone on the severity of sore throat, cough and nausea after tracheal intubation during general anesthesia in distal limb fractures
Public title
Comparison of intravenous and intra-cuff Hydrocortisone on the severity of sore throat, cough and nausea after tracheal intubation during general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: ASA class 1 and 2 anesthesia; lack of drug addiction; aged between 60-18 years; no sore throat or hoarseness prior to surgery
Main exclusion criteria: Acute upper respiratory infections; the history of steroids and narcotics use in a week before surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, patients will be placed in groups A and B and C. Then randomly will be assigned A letter to intravenous hydrocortisone group, B letter to intracuff hydrocortisone group and C letter to distilled water group and will be grouped into blocks of six by using software.
Secondary Ids
1
Registry name
...
Secondary trial Id
..
Registration date
2017-11-21, 1396/08/30
2
Registry name
...
Secondary trial Id
..
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IR.SHMU.REC.1394.185
Health conditions studied
1
Description of health condition studied
Distal limb fractures
ICD-10 code
M84.9
ICD-10 code description
Disorder of continuity of bone, unspecified
Primary outcomes
1
Description
Cough
Timepoint
2, 6 and 24 hours after anesthesia
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Severety of sore throat
Timepoint
2, 6 and 24 hours after anesthesia
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Nausea
Timepoint
2, 6 and 24 hours after anesthesia
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
...
Timepoint
...
Method of measurement
...
Intervention groups
1
Description
In the control group (group C), after intubation, endotracheal tube cuff will be filled with 5-10 ml of distilled water (routine)
Category
Treatment - Drugs
2
Description
In the intervention group (group B), 100 mg hydrocortisone diluted with 5-10 ml of distilled water, will be given intravenously.
Category
Treatment - Drugs
3
Description
In the intervention group (group A), after intubation, endotracheal tube cuff will be filled with 100 mg hydrocortisone diluted with 5-10 ml of distilled water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Hospital
Full name of responsible person
Dr. Javad Noorian
Street address
Imam Hossein (AS) Hospital, End of touhidi 28 meters, Imam street
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research - Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
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 - Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
...
Email
bagheri@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
.......
Email
bagheri@shmu.ac.ir
Web page address
...
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
....
Email
bagheri@shmu.ac.ir
Web page address
........
Sharing plan
Deidentified Individual Participant Data Set (IPD)