Comparison of the effect of intravenous Lidocain and Dexamethasone on post operative sore throat in general anesthesia with endotracheal tube: A clinical trial
The aim Study: Comparison of the effect of of intravenous Lidocain and Dexamethasone on post operative sore throat in general anesthesia with endotracheal tube. After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into A,B and C groups. Randomization will be performed using random block sizes of 3. The study is randomized, single cente. Inclusion criteria: Patients candidate for general anesthesia, Exclusion criteria: ASA class 3 anesthesia risk and higher than , emergent patients, complications of surgery and anesthesia, history of narcotic and anticonvulsant drugs use, craniofacial surgery, acute and chronic upper respiratory airways problems and non supine position. Sample size: 216 patients. The interventions used in the study: Dexamethasone 0.2 mg.kg and Lidocain 1mg.kg. Primary outcome: Rate of sore throat
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010231728N1
Registration date:2017-04-07, 1396/01/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-07, 1396/01/18
Registrant information
Name
Mahshid Mokarian
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23233390433
Email address
mokariani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous Lidocain and Dexamethasone on post operative sore throat in general anesthesia with endotracheal tube: A clinical trial
Public title
The effect of intravenous Lidocain and Dexamethasone on post operative sore throat in general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate for general anesthesia
Exclusion criteria: ASA class 3 anesthesia risk and higher than ; emergent patients; complications of surgery and anesthesia; history of narcotic and anticonvulsant drugs use; craniofacial surgery; acute and chronic upper respiratory airways problems; non supine position
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
216
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Vice chancellor for research, Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
3613773955
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IRSHMUREC.1394.186
Health conditions studied
1
Description of health condition studied
The effect of intravenous Lidocain and Dexamethasone on post operative sore throat in general anesthesia with endotracheal tube
ICD-10 code
T88
ICD-10 code description
Other complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Sore throat
Timepoint
1, 12, 24 hours after surgery
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dexamethasone 0.2 mg/kg IV
Category
Treatment - Drugs
2
Description
Intervention group: Lidocain 1mg/kg IV
Category
Treatment - Drugs
3
Description
Control group: Distilled Water 3 cc IV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr Akram Asad poor
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue, Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Deputy of research, Shahroud University of Medical Sciences, Hafte-Tir Square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of 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
Mahshid Mokarian
Position
Medical Student
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 4499
Fax
Email
mokariani@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 Akram Asad poor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3613773955
Phone
+98 23 3234 2001
Fax
Email
Asadpoura951@mums.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
Mahshid Mokarian
Position
Medical student
Other areas of specialty/work
Street address
shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Postal code
3613773955
Phone
Fax
Email
mokariani@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)