The effect of of intravenus Lidocaine in comparision with oral Clonidine on hemodynamic responses after direct laryngoscopy and tracheal intubation in paitients undergo elective surgury with general anesthesia
As designing double-blind study 86 patients would observe for elective surgery under general anesthesia.patients devided in two groups by random.In group L 1 mg/kg Lidocaine will administer 90 seconds before direct laryngoscopy and intubation intravenously.And in group C 0.2 mg Clonidine will administer 90 minutes before direct laryngoscopy and intubation oraly.patients will compare in defined times(after intubation) for HR-SBP-DBP-MAP variabls.designing study concluded 18 years old and older with ASA class I and II.Patients taking drugs or existence of diseases or factors which affect hemodynamic or autonomic system would excluded from study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102819731N1
Registration date:2015-01-02, 1393/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-02, 1393/10/12
Registrant information
Name
Alireza Maziar
Name of organization / entity
Medical Faculty of Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 1000
Email address
ar_maziar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of of intravenus Lidocaine in comparision with oral Clonidine on hemodynamic responses after direct laryngoscopy and tracheal intubation in paitients undergo elective surgury with general anesthesia
Public title
The effect of of intravenus Lidocaine in comparision with oral Clonidine on heart rate and blood pressure after tracheal intubation in paitients undergo elective surgury with general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria( patients older than 18 years old ; with ASA class I and II).Exclusion criteria ( patients taking drugs that affect hemodynamic or autonomic system ; obese patients(BMI>35) ; patients who have difficult airway(3 miller's criteria +) ; hypovolumic patient ; coronary arteries diseases ; respiratory; renal ; cerebral diseases ; pheochromocytoma ; hypo or hyperthyroidism ; electrocardiographic disturbances ; CHF ,diabetus mellitus ; ,uncontrolled hypertension ; mallampati ; history of allergy or contraindication for drugs used in this study ; pregnant women ; and also patients with more than one laryngoscopic trying for intubation ) .
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Ethical Committee of Research Institue,Tehran University of Medical Science
Street address
Faculty of Medicine, North of Tehran University,Poorsina street, Keshavarz blv
City
Tehran
Postal code
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
1424/130/ ص /92
Health conditions studied
1
Description of health condition studied
Paitients undergo direct laryngoscopy and tracheal intubation with general anesthesia
ICD-10 code
T88
ICD-10 code description
Other complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
systolic blood presure
Timepoint
5 minute before induction,just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy and tracheal intubation
Method of measurement
blood presure manometer in mmHg
2
Description
diastolic blood presure
Timepoint
5 minute before induction,just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy and tracheal intubation
Method of measurement
blood presure manometer in mmHg
3
Description
mean arterial blood presure
Timepoint
5 minute before induction,just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy and tracheal intubation
Method of measurement
blood presure manometer in mmHg
4
Description
heart rate
Timepoint
5 minute before induction,just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy and tracheal intubation
Method of measurement
counting heart ratenting
Secondary outcomes
empty
Intervention groups
1
Description
In Clonidine group 0.2 mg Clonidine tablet is given 90 minutes before elective surgery and 4 ml normal saline is given intravenously 90 seconds before laryngoscopy and intubation as placebo.
Category
Treatment - Drugs
2
Description
In Lidocaine group a placebo tablest as the same shape of 0.2 mg Clonidine tablet is given 90 minutes before elective surgery and 1 mg/kg Lidocaine is given intravenously 90 seconds before laryngoscopy and intubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Alireza Maziar
Street address
North Karegar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Faculty of Medicine, North of Tehran University,Poorsina street, Keshavarz blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
Tehran University of Medical Science
Full name of responsible person
Dr.Alireza Maziar
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Karegar street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 88633039
Email
ar_maziar@razi.tums.ac.irar_maziar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Sussan Soltani Mohammadi
Position
Asssistant Professor
Other areas of specialty/work
Street address
Dr Shariati Hospital, North Karegar street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
soltanmo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr.Alireza Maziar
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr Shariati Hospital, North Karegar street
City
Tehran
Postal code
1411713135
Phone
+98 84901000
Fax
+98 21 8863 3039
Email
ar_maziar@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)