Protocol summary

Summary
Aim of this study is comparison effect of propofol and Dexmedetomidine in ‎hemodynamic ‎response in intubation. This study is clinical trial and double ‎blind in emergency intubation in Valiasr hospital.114 patient divided randomly ‎two groups(Propofol and Dexmedetomidin).At first we inject 2-3 micro gram ‎per kilogram Fentanyl plus 2-3 Lidocaine 2% and 1-3 milligram Midazolam. ‎So after Succinylcholine 1 milligram per kilogram. We inject 0/4 microgram ‎per kilogram Dexmedetomidin in first group and 50-70 milligram per kilogram ‎propofol in second group for hemodynamic response control in patient ‎and intubation. We record hemodynamic sign include systolic blood pressure, ‎diastolic blood pressure, mean arterial pressure, blood heart rate before and ‎after intubation number of cough after intubation.‎ Inclusion criteria: ASA I and II; without chronic disease; lack of drug abuse; ‎age 18-75; both of gender Exclusion criteria: unwillingness to participate in the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102520258N14
Registration date: 2016-10-31, 1395/08/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-31, 1395/08/10
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
Vice President of Research Arak University of Medical Sciences
Expected recruitment start date
2016-10-09, 1395/07/18
Expected recruitment end date
2018-10-10, 1397/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of propofol and Dexmedetomidine in hemodynamic ‎response in emergency intubation
Public title
Comparison effect of propofol and Dexmedetomidine in hemodynamic ‎response in emergency intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I and II; without chronic disease; lack of drug abuse; age 18-75; both of gender Exclusion criteria: Unwillingness to participate in the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Postal code
848176941
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.SBMU.MSP.REC.1395.247

Health conditions studied

1

Description of health condition studied
Emergency intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
systolic blood pressure‎
Timepoint
rate before and after intubation
Method of measurement
millimeter Hg

2

Description
diastolic blood pressure
Timepoint
before and after inubation
Method of measurement
milimeter Hg

3

Description
mean arterial pressure
Timepoint
before and after inubation
Method of measurement
milimeter Hg

4

Description
heart rate
Timepoint
before and after inubation
Method of measurement
number in minute

5

Description
number of cough
Timepoint
after intubation
Method of measurement
number

Secondary outcomes

empty

Intervention groups

1

Description
We inject 0/4 micro gram per kilogram Dexmedetomidin in first group
Category
Treatment - Drugs

2

Description
We inject ‎50-70 milligram per kilogram propofol in second group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Valiasr Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Anesthesiologist
Other areas of specialty/work
Street address
medicine department, Payambarazam complex, Basij square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
alikamaliir@yahoo.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 Alireza Kamali
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
alikama;iir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
medicine department
Full name of responsible person
Dr Mohtaram Esfandiar
Position
resident of emergency medicine
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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