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Comparison of Dexmedetomidine and Lidocaine to cough suppression after anesthesia

Protocol summary

Study aim
Comparison of Dexmedetomidine and Lidocaine to cough suppression after anesthesia
Design
This study is clinical trial and double blind.102 patients candidates general anesthesia in valiasr hospital will enter. We divide patients in 3 groups with simple randomization.It has a control group.We inject Dexmedetomidin and Lidocain and placebo in 3 groups.
Settings and conduct
This study is clinical trial and double blind.102 patients candidates for general anesthesia in valiasr hospital will enter. We divide patients in 3 groups with simple randomization.This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome evaluator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:20 to 60 years old, ASA class I and II,Mallampathi class I and II,no addiction,no smoking,Non-activated airway infections or history of surgery and pathology of the chest and larynx,Lack of inadequacy of the esophagus sphincter (no reflux),body mass index more than 30,Lack of increased Intracranial pressure and intraocular pressure,Duration of surgery is between 60 - 120 minutes Exclusion criteria:Lack of satisfaction of patients,Lack of pulmonary and heart disease,No use Medications creates a cough
Intervention groups
We infuse 0/5 micro gram in kilogram Dexmedetomidine(PFIZER [America]) in 10 milliliter of volume for 10 minute before extubation in intervention group1. Intervention group2: We infuse 1/5 milligram in kilogram Lidocaine (Aboreihan Co) in 10 milliliter of volume for 10 minute in Lidocaine group. We infuse 10 milliliter normal saline for 10 minute in placebo group after extubation.
Main outcome variables
cough, larangospasm, duration of surgery, blood pressure, heart rate, percent of oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N97
Registration date: 2019-02-22, 1397/12/03
Registration timing: registered_while_recruiting

Last update: 2019-02-22, 1397/12/03
Update count: 0
Registration date
2019-02-22, 1397/12/03
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine and Lidocaine to cough suppression after anesthesia
Public title
Comparison of Dexmedetomidine and Lidocaine to cough suppression after anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 60 years old ASA class I and II Mallampathi class I and II no addiction no smoking Non-activated airway infections or history of surgery and pathology of the chest and larynx Lack of inadequacy of the esophagus sphincter (no reflux) body mass index more than 30 Lack of increased Intracranial pressure and intraocular pressure Duration of surgery is between 60 - 120 minutes
Exclusion criteria:
Lack of satisfaction of patients Lack of pulmonary and heart disease No use  Medications creates a cough
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B. Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Vice President of Research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.ARAKMU.REC.1397.140

Health conditions studied

1

Description of health condition studied
Patients candidates general anesthesia
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified

Primary outcomes

1

Description
Cough
Timepoint
Extubation time and Tenth minute and in the recovery until 40 minutes after removing the tracheal tube
Method of measurement
observation

2

Description
Laryngospasm
Timepoint
Extubation time and Tenth minute and in the recovery until 40 minutes after removing the tracheal tube
Method of measurement
observation

3

Description
duration of surgery
Timepoint
after intervention
Method of measurement
minute

4

Description
Percent of oxygen saturation
Timepoint
Immediately after extubation and then every 5 minutes to 40 minutes after the tube exits
Method of measurement
Pulse oximeter

5

Description
Blood pressure
Timepoint
Every 10 minutes to 40 minutes after the extubation of the tracheal tube
Method of measurement
Barometer

6

Description
Heart rate
Timepoint
Every 10 minutes to 40 minutes after the extubation of the tracheal tube
Method of measurement
Count

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: We infuse 0/5 micro gram in kilogram Dexmedetomidine(PFIZER [America]) in 10 milliliter of volume for 10 minute before extubation in intervention group.
Category
Treatment - Drugs

2

Description
Intervention group 2: We infuse 1/5 milligram in kilogram Lidocaine(Aboreihan Co) in 10 milliliter of volume for 10 minute before extubation in Lidocaine group.
Category
Treatment - Drugs

3

Description
Control group: We infuse 10 milliliter normal saline for 10 minute in placebo group after extubation.
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
valiasrhospital@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Deputy, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
m.arjmandzadegan@arakmu.ac.ir
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 Bijan Yazdi
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
yazdi@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
Assistante 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
Soheila Saeedi
Position
Medicine student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
soheilasaeedi73@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 Modir
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
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