Protocol summary

Summary
Aim of this study is comparison effect of Remifentanil and Dexmedetomidine in ‎hemodynamic ‎response in laryngoscopy and orotracheal intubation. This study is clinical trial and double ‎blind in intubation in Valiasr hospital. 124 patients divided randomly ‎four groups(Remifentanil and Dexmedetomidine and Saline and Dexmedetomidine-Remifentanil). Anesthesia induction was performed using propofol 2 mg kg for all patients and then Atracurium 0.4 microgram per kilogram and Midazolam 0.01 milligram per kilogram was injected. We injected 1 micro gram per kilogram Dexmedetomidine in first group and ‎3 cc of Saline in second group and 1 micro gram per kilogram Remifentanil in third group and 0/5 micro gram per kilogram Dexmedetomidine and Remifentanil in fourth group. Systolic, diastolic blood pressure, heart rate, mean arterial pressure, oxygenation similar measured during before and after tracheal intubation; immediately, 5, 10, 15, minutes after intubation. Inclusion criteria: ASA I and II; without chronic disease; lack of drug abuse; ‎age 15-65; both of gender Exclusion criteria: unwillingness to participate in the study.

General information

Acronym
ASS
IRCT registration information
IRCT registration number: IRCT2016092722254N1
Registration date: 2016-11-26, 1395/09/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Samira Afshari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
afshari1370@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomidine and remifentanil for attenuation of hemodynamic responses to laryngoscopy and orotracheal intubation
Public title
Comparison between drugs on hemodynamic changes during tracheal 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 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
2016-04-05, 1395/01/17
Ethics committee reference number
IR.ARAKMU.REC.1394.280

Health conditions studied

1

Description of health condition studied
Intubation
ICD-10 code
Y84.8
ICD-10 code description
other medical peocedures

Primary outcomes

1

Description
mean arterial pressure
Timepoint
before and after inubation
Method of measurement
Blood pressure manometer

2

Description
Oxygenation
Timepoint
before and after inubation
Method of measurement
Pulse Oxymetery

3

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

Secondary outcomes

empty

Intervention groups

1

Description
We injected 1 micro gram per kilogram Dexmedetomidin in first group
Category
Treatment - Drugs

2

Description
We injected ‎3 cc of Saline in second group.
Category
Treatment - Drugs

3

Description
We injected 1 micro gram per kilogram Remifentanil in third group.
Category
Treatment - Drugs

4

Description
We inject 0/5 micro gram per kilogram Dexmedetomidin and Remifentanil in fourth group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-Asr hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Vali-Asr hospital, Pirouzi Ave
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
1294
Grant code / Reference number
1294
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 Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Vali-Asr hospital, Pirouzi Ave
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
00
Email
dr.hemodir@arakmu.ac.ir
Web page address
www.arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
00
Email
dr.hemodir@arakmu.ac.ir
Web page address
www.arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Samira Afshari
Position
Medical Student
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
3814957558
Phone
+98 86 3417 3638
Fax
00
Email
afshari1370@gmail.com
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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