1. Home
  2. Approved trials
  3. » فارسی

Comparison of magnesium sulfate and dexmedetomidine and ondansetron ‎supplementation with lidocaine for pre-laryngoscopic and tracheal intubation ‎gargling in prevention of sore throat and control of hemodynamic changes

Protocol summary

Study aim
Comparison of magnesium sulfate and dexmedetomidine and ondansetron ‎supplementation with lidocaine for pre-laryngoscopic and tracheal intubation ‎gargling in prevention of sore throat and control of hemodynamic changes
Design
The study of the two-course clinical trial of 105 patients was randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients with general anesthesia at Valiasr hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:30 to 60 years, ASA class 1 and 2, No history of sore throat before surgery, No history of head and neck surgery, especially of the throat, No history of drug use, No history of chronic housing use, Lack of sensitivity to the drugs used in this study, Lack of upper airway infection and cold, Malampati more than 2, Lack of liver and kidney failure, No need to use NG-tube during surgery and up to 24 hours after surgery, The duration of surgery should not be less than 45 minutes and not more than 120 minutes Exclusion criteria:Patient dissatisfaction with continuing to study, observation of blood during suction when removing the tracheal tube, for whatever reason, we have to have laryngoscopy twice
Intervention groups
Intervention group 1:Patients will grunt 2 gram Magnesium Sulfate 20 percent (Shahid ghazi Co) plus 100 milligram Lidocaine and 5 millilitre Dextrose 20 percent. Intervention group 2:Patients will grunt 1 microgram Dexmedetomidine (Exir Co) plus 100 milligram Lidocaine and 5 millilitre Dextrose 20 percent. Intervention group 3:Patients will grunt 4 milligram Ondansetron (Exir Co) plus 100 milligram Lidocaine and 5 millilitre Dextrose 20 percent.
Main outcome variables
Cough, hoarseness, sore throat

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N145
Registration date: 2020-07-05, 1399/04/15
Registration timing: registered_while_recruiting

Last update: 2020-07-05, 1399/04/15
Update count: 0
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of magnesium sulfate and dexmedetomidine and ondansetron ‎supplementation with lidocaine for pre-laryngoscopic and tracheal intubation ‎gargling in prevention of sore throat and control of hemodynamic changes
Public title
Comparison of magnesium sulfate and dexmedetomidine and ondansetron ‎supplementation with lidocaine for pre-laryngoscopic and tracheal intubation ‎gargling in prevention of sore throat and control of hemodynamic changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30 to 60 years ASA class 1 and 2 No history of sore throat before surgery No history of head and neck surgery, especially of the throat No history of drug use No history of chronic housing use Lack of sensitivity to the drugs used in this study Lack of upper airway infection and cold Malampati more than 2 Lack of liver and kidney failure No need to use NG-tube during surgery and up to 24 hours after surgery The duration of surgery should not be less than 45 minutes and not more than 120 minutes
Exclusion criteria:
Patient dissatisfaction with continuing to study Observation of blood during suction when removing the tracheal tube For whatever reason, we have to have laryngoscopy twice
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 3 groups A and B and C . In this method, we write a few cards or letters as intervention groups and the same ‎number of cards for the control group, then the cards are mixed. One card is taken out and its ‎allocation is registered and the card is returned to the other cards after leaving. Then the cards ‎are mixed again and then another card is picked up. This process continues to reach a random sequence ‎according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Outcome elevator and analyzer and participant are blind. Outcome elevator and analyzer and participant don't aware from grouping.Drug sets will be covered with foil. After calculating the amount and prescribed at the desired dose.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.ARAKMU.REC.1399.072

Health conditions studied

1

Description of health condition studied
Sore throat
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis, unspecified

Primary outcomes

1

Description
Sore throat
Timepoint
In recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Observation

2

Description
hoarseness
Timepoint
In recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Observation

3

Description
Cough
Timepoint
In recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will grunt 2 gram Magnesium Sulfate 20 percent (Shahid ghazi Co) plus 100 milligram Lidocaine and 5 millilitre Dextrose 20 percent.
Category
Treatment - Drugs

2

Description
Intervention group: atients will grunt 1 microgram Dexmedetomidine (Exir Co) plus 100 milligram Lidocaine and 5 millilitre Dextrose 20 percent. Intervention group
Category
Treatment - Drugs

3

Description
Intervention group: Patients will grunt 4 milligram Ondansetron (Exir Co) plus 100 milligram Lidocaine and 5 millilitre Dextrose 20 percent.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Shirin Pazuki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
pazuki@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Erfaneh Abedzadeh
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vice Chancellor for Research and Technology; Payambar Azam complex, Basij square; Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
Researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Hesamodin Modir
What processes are involved for a request to access data/document
They have to write letters to the professors and the university.
Comments
Loading...