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comparison between Remifenil, lidocaine and fentanil on hemodynamic changes on CABG during laryngoscopy and tracheal intubation

Protocol summary

Summary
Since, uses of different drugs for attention of laryngoscopy and tracheal intubation response is controversy. The aim of this study is to compare the hemodynamic effects of remifentanil , Lidocaine as a IV and spray versus fentanyl for tracheal intubation in patients for coronary artery bypass grafing (CABG). A randomized, double-blined study , 100 patients for coronary artery bypass surgery in referral cardiac surgery are assessed. Subjects received in 5groups: remifentanil, 5 microgram/kg, Fentanyl, 8 micro/kg, and Lidocaine 1.5 mg / kg , Lidocaine 10% as a spay and routine group ( fentanyl 5 micro gram per kg 3 minutes before laryngoscopy are used. Systolic, diastolic blood pressure, heart rate, mean arterial pressure are similar measured during before and after tracheal intubation; immediately, 1, 3, 5, 10, minutes after intubation. Patients were monitored by dataoscope for hemodynamic changes using electrocardiography. Data in groups compared with ANOVA test. P Value less than 0.05 is significate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138905114492N1
Registration date: 2009-04-04, 1388/01/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-04-04, 1388/01/15
Registrant information
Name
Ebrahim Nasiri formi
Name of organization / entity
Mazansdaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00981513261245- 00981513261246
Email address
enasiri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Mazandaity of Medical Sciencesrsn Univera
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2010-06-05, 1389/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between Remifenil, lidocaine and fentanil on hemodynamic changes on CABG during laryngoscopy and tracheal intubation
Public title
Comparison between drugs on hemodynamic changes during tacheal intubation for CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria are: CABG candidated patients, 50-85 years old, ASA III, IV Exclusion Criteria are : Difficult Intubation, laryngoscopy and tracheal intubation time more than 30 second, more than two time tried for intubation, Sensitivity to local anesthetic drugs
Age
From 50 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
routine group as a control group

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Moalem Square, Chancelar of research of Mazandaran University of Medical Sciences
City
Sari
Postal code
4817844718
Approval date
2009-03-04, 1387/12/14
Ethics committee reference number
87-41 (2009/03/04)

Health conditions studied

1

Description of health condition studied
Hemodynamic change, Local anesthesia, tracheal intubation , CABG
ICD-10 code
-
ICD-10 code description
-

2

Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Systolic Blood pressure
Timepoint
from 2 to 5 minutes
Method of measurement
We used invasive arterial line blood pressure monitoring with datascope prouducted in USA

2

Description
Diastolic Blood pressure
Timepoint
2-5 min
Method of measurement
We used invasive arterial line blood pressure monitoring with datascope prouducted in USA

3

Description
Heart rate
Timepoint
2- 5 Min
Method of measurement
We used invasive arterial line blood pressure monitoring with datascope prouducted in USA

4

Description
Premature ventricular contraction (PVC)
Timepoint
Before intubation, continuous monitoring after intubation up to the 10th minute
Method of measurement
We used invasive arterial line blood pressure monitoring with datascope prouducted in USA

5

Description
SPo2
Timepoint
2- 5 minutes interval
Method of measurement
Pulse Oximetry instrument

6

Description
Mean arterial pressure
Timepoint
2-5 Min
Method of measurement
We used invasive arterial line blood pressure monitoring with datascope prouducted in USA

Secondary outcomes

empty

Intervention groups

1

Description
Remifentanil 0.5 microgram per kilogram , 3 min before laryngoscopy
Category
Treatment - Drugs

2

Description
Spray of 10% lidocaine 2 puff to supraglotic 3 min before laryngoscopy
Category
Treatment - Drugs

3

Description
Lidocaine IV 1.5 mg/kg 3 min before laryngoscopy
Category
Treatment - Drugs

4

Description
Fentanyl 8 micro gram per kilogram 3 min prior Laryngoscopy
Category
Treatment - Drugs

5

Description
Fentanyl 3-5 Micrograme per kilogram 3 min before laryngoscopy as routine or control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrateh Fatemah Hospital (educational hospital and center of heart surgery hospital in sari)
Full name of responsible person
Ebrahim Nasiri, Msc of anesthesiology and Academic faculty member
Street address
Dept of anesthesia,Operating room and emergency Medicine, Mazandaran University of medical Sciencences
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Enayati or Dr Haghshenas
Street address
Moalem Square, Deputy of research, Mazandaran University of Medical Sciences
City
Sari
Grant name
تحقیقات و آموزش
Grant code / Reference number
41
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammad reza Haghshenas
Position
Virologist, Deputy of research
Other areas of specialty/work
Street address
moalem square, Deputy of research of Mazandaran University of Medical Sciences
City
Sari
Postal code
4817844718
Phone
+98 15 1325 7230
Fax
+98 15 1325 7230
Email
mhaghshenas@mazums.ac.ir
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri
Position
MSc of Anesthesiology and Academic Faculty member
Other areas of specialty/work
Street address
Dept Anesthesia, operating room and Emergency Medicine, Mojtamehe Payambare Azam, Mazandaran University of Medical Sciences, Paramedical school.
City
Sari
Postal code
4818846693
Phone
+98 15 1354 3246
Fax
+98 15 1354 2469
Email
rezanf2002@yahoo.com; enasiri@mazums.ac.ir; ebrahim.nasiri.f@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri
Position
MSc of anesthesiology , Academic Faculty member
Other areas of specialty/work
Street address
Dept of anesthesia, Operating room and Emergency Medicine, Mazandaran University of Medical Sciences
City
Sari
Postal code
4818846693
Phone
+98 15 1354 3246
Fax
+98 15 1354 2469
Email
rezanf2002@yahoo.com; enasiri@mazums.ac.ir; ebrahim.nasiri.f@gmail.com
Web page address
www.mazums.ac.ir

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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