The effect of normal saline gargling in post intubation sore throat
Design
Randomized clinical trial with two groups of intervention and control, randomized 4-block, phase 3 per 100 patients. Due to the intervention, it is not possible to blind patients. Random randomization is done using SPSS software and syntax.
Settings and conduct
100 patients in the operating room of Imam Hossein (AS) Hospital in Shahroud are divided into intervention and control groups by randomization of 4 blocks, and in the intervention group, a normal saline solution is gargled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 to 50 years, general anesthesia and endotracheal intubation, Class 1 and 2 of anesthesia risk, no airway and intubation problems, patient-related limb surgery,and Maximum duration of anesthesia is 2 hours. Exclusion criteria: Patient dissatisfaction with participation in the study, history of seizures in the patient and history of smoking, drugs, painkillers or psychiatric drugs
Intervention groups
intervention group gargle 40 degrees normal saline solution 3 times, 30 seconds apart for 5 minutes each, which is done half an hour before the operation. There is no intervention in the control group.
Main outcome variables
Age; Gender; Rate of sore throat; Intubation time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210828052308N1
Registration date:2021-09-04, 1400/06/13
Registration timing:prospective
Last update:2021-09-04, 1400/06/13
Update count:0
Registration date
2021-09-04, 1400/06/13
Registrant information
Name
Babak Naghizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
babak.ng.1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-19, 1400/06/28
Expected recruitment end date
2021-12-19, 1400/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of normal saline gargling in post intubation sore throat
Public title
The effect of normal saline gargling in post intubation sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the person should be between 20 and 50 years
For limb surgery, general anesthesia and endotracheal intubation are required
has a risk of Class 1 & 2 of anesthesia risk (according to American society of anesthesiologist's classification)
The patient does not have airway and intubation problems
The patient's operation is related to the limb
The duration of anesthesia should not exceed 2 hours.
Exclusion criteria:
The patient does not have personal consent to participate in the study and does not fill in the written form of informed consent
The patient has a history of seizures.
The patient has a history of smoking, drugs, painkillers or Psychiatric drugs
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After informed concern participants, patients are assigned based on quadruple random blocks in the intervention group (gargling normal saline solution) or control (not gargling normal saline solution). Using SPSS software and random randomization syntax, a table 100 pieces were prepared and according to this table, 100 envelopes were prepared and contained 50 letters A= intervention and 50 letters B=control , will be given to the operating room technician by the person in charge of randomization. Based on this envelope, the participant in the project is assigned to a group and the envelope is discarded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Square - shahroud-semnan-iran
City
shahroud
Province
Semnan
Postal code
3614773947
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.SHMU.REC.1400.111
Health conditions studied
1
Description of health condition studied
Post operative sore throat
ICD-10 code
J04
ICD-10 code description
Acute laryngitis and tracheitis
2
Description of health condition studied
Post operative sore throat
ICD-10 code
J02
ICD-10 code description
Acute pharyngitis
Primary outcomes
1
Description
Percentage of sore throat after intubation in operating room patients
Timepoint
Evaluation of sore throat intensity at 1, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group are given 40 degrees normal saline solution before surgery. These patients should gargle 3 times, 5 minutes apart, half an hour before the operation. Gargling should be done for 30 seconds each time.
Category
Prevention
2
Description
Control group: There is no intervention in the control group. But the necessary recommendations were also given to this group before and after the operation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Shahroud city
Full name of responsible person
babak naghizade
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Square - shahroud-semnan-iran
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mohammad hasan emamian
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Square - shahroud - semnan - iran
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
babak naghizade
Position
general physician intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Square - shahroud - semnan - iran
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
babak naghizade
Position
general physician intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Square - shahroud - semnan - iran
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
babak naghizade
Position
general physician intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Square - shahroud - semnan - iran
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
Undecided - It is not yet known if there will be a plan to make this available