Two groups of patients with head trauma conventional medical protocol before undergoing intubation (succinylcholine 1.5 mg / kg + rapid intravenous fentanyl 2 mg / kg + intravenous etomidate 0.3 mg / kg through IV) were are but one group in addition to the common protocol, the amount of lidocaine to intubating 1 mg / kg perfusion within 60-30 seconds will be used.
Patients' vital signs such as heart rate, respiratory rate of systolic, diastolic and mean arterial (MAP) once before and once after intubation between the two groups of patients studied and the results are compared. Other variables such as need, GCS patients, the diagnosis Trmay such as EDH, SDH, SAH, and .... We will examine the main factors. It should be noted that the plans for trained nurses recorded patients' vital signs before and after intubation would be completely unaware of the protocol will be used for sedation intubation.
The primary outcomes of the decrease in mean arterial pressure (MAP) and heart rate, and the secondary outcome was defined as the use of inotropic drugs or isotonic fluids.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042813150N1
Registration date:2013-05-08, 1392/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-08, 1392/02/18
Registrant information
Name
Mohammad.ali Najjari Asl
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 6302
Email address
ali_njr@yahoo.com
Recruitment status
Recruitment complete
Funding source
research vice-chancellor Tabriz University of Medical Sciences, Faculty of Medicine
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2013-07-07, 1392/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Post intubation hemodynamic effects of intravenous lidocaine in patients with severe brain trauma
Public title
Post intubation hemodynamic effects of intravenous lidocaine in patients with severe brain trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all patients aged 65-18 years with traumatic brain injury with GCS <9; patients who have been intubated prior to admission to the emergency room; before referring patients to the emergency room, and inotropic drugs have not received isotonic fluids. Exclusion criteria: patients aged 18 years and above 65 year; patients with heart failure; in patients with shock, hypovolemia, sepsis and cardiogenic reason; patients with a previous history of heart disease and hypertension; start inotropic drugs before intubation and evidence of cardiac arrhythmia.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz Azadi Street - Street Golgasht - Central Building University of Medical Sciences - Tel 3355921-25 Fax: 3355944
City
Tabriz
Postal code
Approval date
2013-04-09, 1392/01/20
Ethics committee reference number
925
Health conditions studied
1
Description of health condition studied
Patients with severe head trauma
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Heart Rate
Timepoint
Once before and once after intubation
Method of measurement
by an automatic blood pressure cuff
2
Description
systolic Arterial pressure
Timepoint
Once before and once after intubation
Method of measurement
by an automatic blood pressure cuff
3
Description
Diastolic arterial pressure
Timepoint
Once before and once after intubation
Method of measurement
by an automatic blood pressure cuff
4
Description
mean arterial pressure
Timepoint
Once before and once after intubation
Method of measurement
by an automatic blood pressure cuff
Secondary outcomes
1
Description
The rate of use of isotonic fluids
Timepoint
After intubation
Method of measurement
Chart of Fluids
2
Description
The rate of use of inotropic agents
Timepoint
After intubation
Method of measurement
Chart of drugs
Intervention groups
1
Description
In the control group patients before intubation only common protocols (conventional pharmacological protocol for patients with head trauma (succinylcholine 1.5 mg / kg + rapid intravenous fentanyl 2 mg / kg + intravenous etomidate 0.3 mg / kg perfusion )), is used for intubation.
Category
Treatment - Drugs
2
Description
Intervention group patients before intubation in addition to standard protocols (conventional pharmacological protocol for patients with head trauma (succinylcholine 1.5 mg / kg + rapid intravenous fentanyl 2 mg / kg + intravenous etomidate 0.3 mg / kg as iv)), the amount of lidocaine to intubating 1 mg / kg, intravenous use within 60-30 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Imam Reza Hospital
Full name of responsible person
Dr Peyman Moharamzadeh
Street address
Emergency Department of Imam Reza Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Tabriz University of Medical Sciences, Faculty of Medicine
Full name of responsible person
Dr. Ali Meshkini
Street address
research vice-chancellor Tabriz Faculty of Medicine.Tabriz Azadi Street - Street Golgasht - Central Building University of Medical Sciences
City
Tabriz
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, Tabriz University of Medical Sciences, Faculty of Medicine
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr mohammad Ali Najjari Asl
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Emergency Department of Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1658 6302
Fax
Email
ali_njr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Peyman Moharamzadeh
Position
Assistant Professor - Emergency Medicine
Other areas of specialty/work
Street address
Emergency Department of Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
moharramzadehp@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Najjari Asl
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Emergency Department of Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1658 6302
Fax
Email
ali_njr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)