Investigating the effect of three different doses of intranasal dexamethasone in preventing sore throat after surgery in patients under general anesthesia
1. Determining and comparing the frequency distribution of sore throat in recovery (hours 2, 6, 12 and 24 hours) in the four studied groups
2. Determining and comparing the severity of sore throats in recovery (hours 2, 6, 12 and 24) in the four studied groups
3. Determining and comparing the first time to tolerate liquids and solids in the four studied groups
4. Determining the average time of the first request for additional pain relief in the four studied groups
5. Determining and comparing the average dose of additional painkillers in the four studied groups
Design
Clinical trial on four parallel groups, three-way blind, randomized, phase two on 100 patients
Settings and conduct
The use of dexamethasone and saline with a specific dose in four groups and a comparison of its effect on reducing sore throat after surgery under general anesthesia at Faiz Ophthalmology Center in Isfahan, where the patient, the clinical caregiver, and the outcome assessor are unaware of which drug was used for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. ASAI-II
2. Age between 15-65
3. Candidate for surgery requiring tracheal tube
4. Completion of informed consent to participate in the study
Exclusion criteria:
1. Presence of mental disorders
2. Active upper respiratory tract infection
3. History of chronic use of sedatives, alcohol and narcotics
4. Narcotics use
5. Allergy to the drugs used in the study
6. Severe obstructive pulmonary disease and asthma
7. History of recent corticosteroid therapy
8 Smokers
9. Pregnant women
10. People with nasal problems such as nasal polyps and nasal deviation
Intervention groups
Recipient of Dexamethasone (D1 , D2 , D3) and Saline (S)
Main outcome variables
Severity of sore throat, cough, hoarseness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N23
Registration date:2023-07-27, 1402/05/05
Registration timing:prospective
Last update:2023-07-27, 1402/05/05
Update count:0
Registration date
2023-07-27, 1402/05/05
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
2023-08-05, 1402/05/14
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of three different doses of intranasal dexamethasone in preventing sore throat after surgery in patients under general anesthesia
Public title
The effect of three different doses of intranasal dexamethasone in preventing sore throat after surgery in patients under general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASAI-II
Age between 18-65
Candidates for general surgery under anesthesia
Completion of informed consent to participate in the study
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly divided into four groups using the table of random numbers resulting from the Random Allocation software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patient, the clinical caregiver who records the data, and the data analyzer are unaware of the grouping of the patients and the studied drugs.
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
Approval date
2023-07-16, 1402/04/25
Ethics committee reference number
IR.MUI.MED.REC.1402.155
Health conditions studied
1
Description of health condition studied
sore throat
ICD-10 code
T88.8
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Sore throat
Timepoint
In recovery (every half hour) and in the ward (at zero hours, 2, 6, 12, and 24)
Method of measurement
Scoring system for sore throat,cough and hoarseness
2
Description
Hoarseness
Timepoint
In recovery (every half hour) and in the ward (at zero hours, 2, 6, 12, and 24)
Method of measurement
Scoring system for sore throat,cough and hoarseness
3
Description
Cough
Timepoint
In recovery (every half hour) and in the ward (at zero hours, 2, 6, 12, and 24)
Method of measurement
Scoring system for sore throat,cough and hoarseness
4
Description
Score of pain
Timepoint
In recovery (every half hour) and in the ward (at zero hours, 2, 6, 12, and 24)
Method of measurement
Visual Analogue Scale
5
Description
Total dose of analgesic
Timepoint
In the first 24 hours after the operation
Method of measurement
It is recorded in the data collection form
6
Description
Extubation time
Timepoint
After Extubation
Method of measurement
Clock
7
Description
Length of stay in recovery
Timepoint
After exiting recovery
Method of measurement
Clock
8
Description
Patient satisfaction score
Timepoint
At the end of 24 hours
Method of measurement
Likert scale
9
Description
Beginning time of using liquid foods
Timepoint
After using liquid foods
Method of measurement
Clock
10
Description
Beginning time of using solid foods
Timepoint
After using solid foods
Method of measurement
Clock
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,in group D1, dexamethasone 6 mg, in group D2, dexamethasone 8 mg, in group D3, dexamethasone 10 mg was administered intranasally.
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
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
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
Gholamreza Asgari
Street address
No 4, Medical university of Isfahan, Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz Hospital ،modares st
City
Esfahan
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz hospital, modarres St
City
Esfahan
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital, Modares St
City
Esfahan
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