Protocol summary

Summary
The aim of this study is to compare the effect of 10% lidocaine spray on blade of laryngoscope with IV lidocaine on the cardiovascular responses to laryngoscopy and endotracheal intubation in patient with elective surgery. Inclusion criteria include: Age range 15-65 years; Patients with anesthesia class 1; Patients are willing to participate in the study Exclusion criteria include: More than once effort to laryngoscopy and intubation; َAllergy to lidocaine; Weight more than 100 kg This study is a simple randomized clinical trial.The study population is all the patients who are admitted to the Gonabad hospitals for elective surgery. In this study 90 patients with age range 15-65 years and anesthesia class 1 that undergo elective surgery are selected. patients with block permutation method can be divided into three groups. Every group was placed in the supine position on the operating table. Before induction of anesthesia 3-5 cc per kg Ringer, 1 mg midazolam and 1 mic per kg fentanil as premed received. Position of patients from the beginning to the end of the study are supine. Anesthetic agents unified into three groups and given a specified dose.(propofol 2mg per kg, atracurium 4 mg per kg and fentany 2 mic per kg).In IV Group Intravenous lidocaine 1 mg per kg 60-90 seconds before laryngoscopy and in spray group 1/5 mg per kg of 10% lidocaine spray three minutes after the induction sprayed on the blade of laryngoscope.In control group didnt use any drug.Their blood pressure (systolic, diastolic and mean) and heart rate immediately before and immediately after laryngoscopy and 1, 3 and 5 minutes after laryngoscopy is measured and recorded. Then the results of three groups will compare and final result will be announced.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061213647N1
Registration date: 2014-03-11, 1392/12/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Mahdi Esmaeili
Name of organization / entity
Gonabad University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 5027
Email address
esmaeili.mahdi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Science
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 10% lidocaine spray on blade of laryngoscope with IV lidocaine on the cardiovascular responses to laryngoscopy and endotracheal intubation in patients with elective surgery
Public title
The effect of Spray lidocaine on the blade of laryngoscope on cardiovascular responses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age range 15-65 years; Patients with anesthesia class 1; Patients with Mallampati airway class 1; Patients are willing to participate in the study Exclusion criteria: More than once in an effort to laryngoscopy and intubation; َAllergy to lidocaine; Weight more than 100 kg
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Gonabad University of Medical Science
Street address
Gonabad University Of Medical Science, Asian Road, Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
Gmu.Rec.1392.19

Health conditions studied

1

Description of health condition studied
Associated with 10% lidocaine spray on the blade of laryngoscope and intravenous lidocaine on cardiovascular responses
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Systolic Blood Pressure
Timepoint
Immediately before intrvention, Immediately after intervention and 1, 3, 5 minute after intervention
Method of measurement
Mmhg with Sphygmomenometer

2

Description
Heart rate
Timepoint
Immediately before intrvention, Immediately after intervention and 1, 3, 5 minute after intervention
Method of measurement
Beat per minute with pulseoximetery

3

Description
Dyastolic Blood Pressure
Timepoint
Immediately before intrvention, Immediately after intervention and 1, 3, 5 minute after intervention
Method of measurement
Mmhg with Sphygmomenometer

4

Description
Mean Arterial Blood pressure
Timepoint
Immediately before intrvention, Immediately after intervention and 1, 3, 5 minute after intervention
Method of measurement
Mmhg with Sphygmomenometer

Secondary outcomes

empty

Intervention groups

1

Description
The patients placed in 3 groups. The three groups are given same doses of anesthetics(Propofol 2 mg/kg, Atracurium 0/4 mg/kg and Fentanyl 2 mic/kg).Intravenous lidocaine in Group IV 1 mg/kg 60-90 seconds before laryngoscopy injected. Their blood pressure (systolic, diastolic and mean) and heart rate immediately before and immediately after laryngoscopy and 1, 3 and 5 minute after laryngoscopy is measured and recorded
Category
Prevention

2

Description
The patients placed in 3 groups. The three groups are given same doses of anesthetics(Propofol 2 mg/kg, Atracurium 0/4 mg/kg and Fentanyl 2 mic/kg) and in spray group 10% lidocaine spray 1/5 mg/kg three minutes after induction on the blade of laryngoscop is pressed.Their blood pressure (systolic, diastolic and mean) and heart rate immediately before and immediately after laryngoscopy and 1, 3 and 5 minute after laryngoscopy is measured and recorded
Category
Prevention

3

Description
The patients placed in 3 groups. The three groups are given same doses of anesthetics(Propofol 2 mg/kg، Atracurium 0/4 mg/kg and Fentanyl 2 mic/kg) and in control group did not use any drug.Their blood pressure (systolic, diastolic and mean) and heart rate immediately before and immediately after laryngoscopy and 1, 3 and 5 minute after laryngoscopy is measured and recorded
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad University Of Medical Science
Full name of responsible person
Mahdi Esmaeili
Street address
Gonabad University Of Medical Science, Asian Road, Gonabad
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Gonabad University of Medical Science
Full name of responsible person
Doctor Arash Hamzei
Street address
Gonabad University of Medical Science, Asian Road, Gonabad
City
Gonabad
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 of Gonabad 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
Gonabad University of Medical Science
Full name of responsible person
Mahdi Esmaeili
Position
MSc of Critical Care Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Science, Asian Road, Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
Esmaeili.Mahdi@gmu.ac.ir; Mahdi.Esmaeili@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Science
Full name of responsible person
Doctor Arash Hamzei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Gonabad University of Medical Science, Asian road, Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
Arash_hamzei@yahoo.com
Web page address
Gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Science
Full name of responsible person
Mahdi Esmaeili
Position
MSc of Critical Care Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Science, Asian Road, Gonabad
City
Gonabad
Postal code
9691793714
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
Esmaeili.Mahdi@gmu.ac.ir; Mahdi.Esmaeili@yahoo.com
Web page address
Gmu.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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