Protocol summary

Study aim
Determination of the effect of intravenous Dexamethasone in the prevention of Laryngeal Mask Airway(LMA) complications including nausea&vomiting,sore throat,cough& chills in inguinal surgeries.
Design
Clinical trial with control&intervention groups,with parallel groups,double blind,randomized,phase3 on140 patients.Patients will be assigned between 2groups using a random quadruple block method.
Settings and conduct
In this study,a sample of 140 patients who are candidate for inguinal region surgery and will have general anesthesia with classical LMA in Imam Reza, Imam Khomeini and Fatemi hospitals in Ardabil, is selected.Patients will be assigned between 2groups using a random quadruple block method and It is double-blind. Except for the executor of the project, the rest, including patients and clinical caregivers and evaluators and analyzers, will be unaware of the type and amount of medicine. Group1:After establishing the airway,Dexamethasone 8mg/IV/stat will be injected. Group2:After establishing the airway,Normal Saline 2cc/IV/stat will be injected. After the operation,in recovery and also 2&4 hours after the operation,patients are examined for complications ,and recorded.Finally,they will be analyzed.
Participants/Inclusion and exclusion criteria
Patients who are candidate for inguinal surgery and will have general anesthesia with classical LMA are selected. If the patient is not satisfied or American Society of Anesthesiologists greater than or equal to3, he/she will not enter the study.
Intervention groups
Intervention group(70 patients) will have general anesthesia with LMA.After establishing the airway,Dexamethasone 8mg/IV/stat will be injected. Control group(70 patients) will have general anesthesia with LMA. After establishing the airway,Normal Saline 2cc/IV/stat will be injected.
Main outcome variables
Nausea&vomiting;Cough;Sore throat;Chills;Odynophagia;Dyspnea;Epigastric pain

General information

Reason for update
Acronym
LMA=Laryngeal Mask Airway, ASA=American Society of Anesthesiologists
IRCT registration information
IRCT registration number: IRCT20200730048255N1
Registration date: 2020-09-05, 1399/06/15
Registration timing: registered_while_recruiting

Last update: 2020-09-05, 1399/06/15
Update count: 0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Ahmad Ghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3324 8888
Email address
dr.ghaziahmad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-24, 1399/06/03
Expected recruitment end date
2020-10-24, 1399/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous Dexamethasone on prevention of complications of laryngeal mask airway (LMA) in inguinal region surgeries
Public title
Effect of intravenous Dexamethasone on prevention of complications of laryngeal mask airway in inguinal region surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for inguinal region surgery (hernia and unilateral varicocele repair) and undergo general anesthesia using classical LMA is selected.
Exclusion criteria:
Dissatisfaction of eligible patients to participate in the study American Society of Anesthesiologists ≥ 3
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
. In terms of random allocation, patients will be assigned between two groups using a random quadruple blocks method. Thus, we will create blocks A, B, C and D and it will be randomly assigned to the relevant groups (Dexamethasone group and control group). The blocks are pre-prepared and randomly assigned to the control group and the Dexamethasone group. Except for the executor of the project, the rest, including patients and clinical caregivers and evaluators and analyzers, will be unaware of the type and amount of medicine.
Blinding (investigator's opinion)
Double blinded
Blinding description
In terms of blinding, Dexamethasone and Normal Saline will be given to the anesthesia technician in ready-made syringes and will be injected in order of quadruple blocks.In terms of outcomes measurement, the assessor will measure the studied variables and he will be unaware of the classification of the group receiving Dexamethasone or Normal Saline. Except for the executor of the project, the rest, including patients and clinical caregivers and evaluators and analyzers, will be unaware of the type and amount of medicine.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Dadghostari square
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.ARUMS.REC.1399.232

Health conditions studied

1

Description of health condition studied
Inguinal region surgeries
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nausea and vomiting
Timepoint
After extubation, postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Nausea and Vomiting score: score 1: no nausea and vomiting; score 2: nausea; score 3: 1 or 2 times nausea and vomiting; score 4: nausea and vomiting more than 2 times

2

Description
Cough
Timepoint
Postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Asking the patient

3

Description
Sore throat
Timepoint
Postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Asking the patient

4

Description
Chills
Timepoint
Postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Chills score: score 0: No chills; score 1: peripheral vasoconstriction and peripheral cyanosis without specific cause but without visible muscle contraction; score 2: visible contraction limited to one muscle group; score 3: visible contraction in more than one muscle group; score 4: Clear muscle activity throughout the body

5

Description
Odynophagia
Timepoint
Postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Asking the patient

6

Description
Dyspnea
Timepoint
Postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Asking the patient

7

Description
Epigastric pain
Timepoint
Postoperative recovery, 2 and 4 hours after surgery
Method of measurement
Asking the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (70 patients): This group will have general anesthesia with LMA. After establishing the airway, Dexamethasone 8 mg / IV / stat will be injected.
Category
Prevention

2

Description
Control group (70 patients): This group will have general anesthesia with LMA. After establishing the airway, Normal Saline 2cc / IV / stat will be injected.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Ahmad Ghazi
Street address
Near to Islamic Azad University, Basij square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3086
Email
dr.ghaziahmad@gmail.com

2

Recruitment center
Name of recruitment center
Dr. Fatemi Hospital
Full name of responsible person
Dr. Masood Entezariasl
Street address
Imam Khomeini street, Sarein Station
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
masoodentezari2003@yahoo.com

3

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Arezoo Fekrat
Street address
Shahidan Noei Aghdam street, Ataei street
City
Ardabil
Province
Ardabil
Postal code
5619647531
Phone
+98 45 3325 1401
Email
arezoo.fekrat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Street address
Deputy of researches and technology, Ardabil University of Medical Sciences, Dadghostari square
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3326 2925
Email
F.pourfarzi@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Arezoo Fekrat
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Malata Restaurant, the beginning of the lane of Karshenasan, Keshavarzi Square
City
Ardabil
Province
Ardabil
Postal code
5615861364
Phone
+98 45 3371 0774
Email
arezoo.fekrat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ahmad Ghazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital,
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3086
Email
dr.ghaziahmad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ahmad Ghazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital,
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3086
Email
dr.ghaziahmad@gmail.com

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
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