Protocol summary

Summary
Single-blind randomized clinical trial study will done to evaluate the effect of inhaled and intravenous lidocaine on hemodynamic response in endotracheal intubation patient that hospitalized in ICU and between 25 to 40 years old in Arak Vali-Asr Hospital. Patients randomized to 3 groups (1, 2 intervention and control). The sample size was estimated for each group of 64 patient. In 1st intervention group 0.75 mg/kg lidocaine 4% will sprayed to the larynx and gloat, 2 minutes before intubation and the same dose will sprayed at intubation time. In 2th intervention group 0.75 mg/kg lidocaine 2% was injected intravenously, 2 minutes before intubation and the same dose will injected at intubation time. The main drugs used in the control group and of any type of lidocaine is not used. Inclusion criteria: patients between 25 to 40 years old admitted to the ICU and indication for endotracheal intubation; patients without underlying disease such as diabetes, hypertension, cardiovascular disease, kidney and liver diseases, respiratory diseases, recent respiratory infection; patients classified for 1 or 2 ASA; obtaining informed consent from attendant patients for the study. Exclusion criteria: patients who had a history of lidocaine hypersensitivity; pregnancy and lactation The systolic and diastolic blood pressure, mean arterial pressure and heart rate in the intervention groups 1 and 2 and the control group will determined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080823552N1
Registration date: 2015-09-29, 1394/07/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-29, 1394/07/07
Registrant information
Name
Abolfazl Jokar
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 2134
Email address
dr.a.jokar@gmail.com
Recruitment status
Recruitment complete
Funding source
Deputy Minister for Research and Technology َArak University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of inhalation and IV form of lidocaine on hemodynamic responses in patients undergoing Endotracheal intubation
Public title
Effect of different methods of administration of lidocaine on intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients between 25 to 40 years old admitted to the ICU and indication for endotracheal intubation; patients without underlying disease such as diabetes, hypertension, cardiovascular disease, kidney and liver diseases, respiratory diseases, recent respiratory infection; patients classified for 1 or 2 ASA; obtaining informed consent from attendant patients for the study. Exclusion criteria: patients who had a history of lidocaine hypersensitivity; pregnancy and lactation
Age
From 25 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 192
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
Arak University of Medical Sceinces
Street address
Alamolhoda, Maskan, Arak
City
Arak
Postal code
Approval date
2014-11-26, 1393/09/05
Ethics committee reference number
793-171-7

Health conditions studied

1

Description of health condition studied
Hemodynamic changes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
systolic blood pressure
Timepoint
at intubation time and 2 and 5 minutes after Intubation
Method of measurement
mmhg with mercury sphygmomanometer

2

Description
diastolic blood pressure
Timepoint
at intubation time and 2 and 5 minutes after Intubation
Method of measurement
mmhg with mercury sphygmomanometer

3

Description
heart rate
Timepoint
at intubation time and 2 and 5 minutes after Intubation
Method of measurement
heart rate per minute

4

Description
mean arterial pressure
Timepoint
at intubation time and 2 and 5 minutes after Intubation
Method of measurement
mmhg with mercury sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
In 1th intervention group 0.75 mg/kg lidocaine 4% will sprayed to the larynx and gloat, 2 minutes before intubation and the same dose will sprayed at intubation time.
Category
Treatment - Drugs

2

Description
In 2th intervention group 0.75 mg/kg lidocaine 2% was injected intravenously, 2 minutes before intubation and the same dose will injected at intubation time.
Category
Treatment - Drugs

3

Description
The main drugs used in the control group and of any type of lidocaine is not used.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak University of Medical sceinces
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sceinces
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak, School of Medicine
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sceinces
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 sceinces
Full name of responsible person
Dr. Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Arak, Vali Asr Hospital
City
Arak
Postal code
Phone
+98 86 3313 2134
Fax
Email
dr.a.jokar@gmail.com;rahenorayaneh@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. Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Emergency medicine specialist
City
Arak
Postal code
Phone
+86 32222003
Fax
Email
dr.a.jokar@gmaill.com, rahenorayaneh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Jokar
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
dr.a.jokar@gamil.comrahenorayaneh@yahoo.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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