Determination of the Preventive Effect of Intranasal Dexamethasone on Sore throat after Surgery in General Anesthetized Patients
Design
Clinical trials in two community-based and pragmatic groups with parallel blinded, randomized, 40-person groups
Settings and conduct
Using Dexamethasone and Saline with a specific dose in two groups and comparing its effect on reducing sore throat after general anesthesia surgery in Fayyaz center of Isfahan, the patient and researcher are unaware of which drug is used for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18 to 65 years old, both of sex, candidates for eye surgery under general anesthesia, functional classes 1 and 2 of the American Society of Anesthesiologists (ASA), written informed consent to participate in the study.
Exclusion criteria: Mental disorders, upper respiratory tract infection, History of chronic consumption of sedative, alcohol and narcotic drugs, allergies to the drugs used in the study, severe obstructive pulmonary disease and asthma, history of recent corticosteroid therapy.
In the event of any complications during anesthetic induction, more than 1 time attempts to tracheal intubation, prolonged intubation time and using the laryngeal mask.
Intervention groups
Recipient of Dexamethasone (D) and Saline (S)
Main outcome variables
Severity of sore throat, cough, hoarseness.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N7
Registration date:2019-05-31, 1398/03/10
Registration timing:prospective
Last update:2019-05-31, 1398/03/10
Update count:0
Registration date
2019-05-31, 1398/03/10
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-12-09, 1398/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of intranasal dexamethasone on the postoperative sore throat
Public title
Effect of intranasal dexamethasone on prevention of postoperative sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
candidate for eye surgery
Age between 18-75
desire to participate in study
American Society of Anesthesiologists(ASA) Physical Status Classification 1or 2
Exclusion criteria:
mental disorders
Active upper respiratory tract infection
Alcohol or opioid addiction
Allergies to used drugs
History of Recent Corteon Therapy
History of chronic use of sedative medicines
Severe obstructive pulmonary disease and asthma
The occurrence of any anesthetic induction supply
More than once trying to incubate
Prolonged intubation time
Use laryngeal mask
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to intervention and control groups using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind clinical trial after induction of anesthesia and 30 seconds before the tracheal intubation In the intervention group, dexamethasone (2 ml) and in the control group normal saline (2 ml) will be prescribed via the nostril.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib BLVD
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2019-03-19, 1397/12/28
Ethics committee reference number
IR.MUI.MED.REC.1397.374
Health conditions studied
1
Description of health condition studied
sore throat
ICD-10 code
Other spec
ICD-10 code description
T88.8
Primary outcomes
1
Description
sore throat
Timepoint
hours 0,2,4and6 after intubation
Method of measurement
scoring system for sore throat,cough and hoarseness
2
Description
hoarseness
Timepoint
hours 0,2,4and6 after intubation
Method of measurement
scoring system for sore throat,cough and hoarseness
3
Description
cough
Timepoint
hours 0,2,4and6 after intubation
Method of measurement
scoring system for sore throat,cough and hoarseness
4
Description
oxygen saturation percentage
Timepoint
hours 0,2,4and6 after intubation
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After receiving 5 ml / kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Thiopental sodium 5 mg / kg and Atracurium 0.6mg / kg, and the patients underwent mechanical ventilation by mask for three minutes.Immediately before intubation, 4 mg of dexamethasone was injected intra-nasal
Category
Prevention
2
Description
Control group: After receiving 5 ml / kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Thiopental sodium 5 mg / kg and Atracurium 0.6mg / kg, and the patients underwent mechanical ventilation by mask for three minutes.Immediately before intubation, 4 mg of normal salin was injected intra-nasal.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
hamidreza shetabi
Street address
modares st
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaqayeq haghjooye javamard
Street address
vice chacellor of research and technology of university isfahan university of medical sciences hezarjerib st
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
hamidreza shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz Hospital ،modares st
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz hospital, modarres St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3668 8138
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available