Comparison of Dexmedetomidine , Lidocaine , Magnesium Sulfate and Remifentanil on stimulatory responses and cough suppression during tracheal tube removal among patients under general anesthesia
Comparison of Dexmedetomidine, Lidocaine, Magnesium Sulfate and Remifentanil to reduce stimulatory responses and cough suppression when tracheal tube removal
Design
The double blind randomized clinical trial, consisted of 120 patients who are randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
The study population are patients undergoing general anesthesia, attending Valiasr hospital in Arak who are divided into 4 groups by simple randomization using envelopes. The study is double-blind in which outcome evaluator, data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 20 to 60 years old, ASA class 1 and 2, Malampati class ӏ and ӏӏ, Both gender, Not smoking, Not addicted, Lack of active airway infection or having a history of surgery and pathology of the chin and larynx, Body mass index less than 30, the duration of surgery is between 60 and 120 minutes
Exclusion criteria: Dissatisfaction of patients, lung and heart disease, not taking cough medicines, esophageal sphincter insufficiency and (lack of reflux), increased intracranial pressure and intraocular pressure
Intervention groups
Intervention group 1: infusion of 0.5 microgram/kilogram Dexmedetomidine slowly in 10 minutes.
Intervention group 2: infusion of 1.5 milligram/kilogram Lidocaine slowly in 10 minutes.
Intervention group 3: infusion of 1 microgram/kilogram Fentanyl slowly in 10 minutes.
Intervention group 4: infusion of 30 milligram/kilogram magnesium sulphate slowly in 10 minutes.
Main outcome variables
Cough, laryngospasm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N149
Registration date:2020-09-23, 1399/07/02
Registration timing:registered_while_recruiting
Last update:2020-09-23, 1399/07/02
Update count:0
Registration date
2020-09-23, 1399/07/02
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
2020-06-09, 1399/03/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine , Lidocaine , Magnesium Sulfate and Remifentanil on stimulatory responses and cough suppression during tracheal tube removal among patients under general anesthesia
Public title
Comparison of Dexmedetomidine , Lidocaine , Magnesium Sulfate and Remifentanil on cough suppression during tracheal tube removal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 60 years
ASA class 1 and 2
Malampati class ӏ and ӏӏ
Body mass index less than 30
The duration of surgery is between 60 and 120 minutes
Exclusion criteria:
Dissatisfaction of patients
lung and heart disease
Take cough medicines
Active airway infection or having a history of surgery and pathology of the chin and larynx
Esophageal sphincter insufficiency and (lack of reflux)
Increased intracranial pressure and intraocular pressure
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with envelopes into 4 groups of A; B; C and D.
In this method, we write some letters on the cards as intervention groups and the same numbers on the 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 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 of grouping.
Placebo
Not 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 square ,Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.ARAKMU.REC.1399.093
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Cough
Timepoint
At the beginning of the study and then every 5 minutes to 40 minutes
Method of measurement
Observation
2
Description
Laryngospasm
Timepoint
At the beginning of the study and then every 5 minutes to 40 minutes
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We infuse 0.5 microgram/kilogram Dexmedetomidine (Exir company, Tehran, Iran) slowly during 10 minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: We infuse 1.5 milligram/kilogram Lidocaine (Caspian company, Rasht; Iran) slowly during 10 minutes.
Category
Treatment - Drugs
3
Description
Intervention group 3: We infuse 1 micro gram in kilogram Fentanyl (Normon,S.A company; Madrid; Spain) slowly in 10 minutes.
Category
Treatment - Drugs
4
Description
Intervention group 4: We infuse 30 milligram/kilogram magnesium sulphate 20% (Shahid Ghazi company, Tabriz, Iran) slowly during 10 minutes.
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 square
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 Esmaeel Moshiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital; Valiasr square; Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Web page address
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 square, 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
Ehsan Jafarzadeh
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
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
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
Title and more details about the data/document
Age, sex, information on cough and laryngospasm and any other information that is collected and analyzed
When the data will become available and for how long
After finishing the work
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research
From where data/document is obtainable
Dr. Hesamodin Modir
What processes are involved for a request to access data/document