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To compare the effect of intravenous Rapifen and Lidocaine to control hemodynamic responses in laryngoscopy and intubation

Protocol summary

Summary
The aim of this study is to compare the effect of intravenous Rapifen and Lidocaine to control hemodynamic responses in laryngoscopy and intubation. Its applied objective is to use a method that better controls blood pressure and heart rate in laryngoscopy and intubation. The main criterion for patients to include this study was age (15-60 years old). Also, the criteria to exclude this study are patients with narcotics addiction, cardiopulmonary diseases, hypertension (more than 140/90), chronic diseases using narcotics, and pregnant women. Sample population include 120 patients needing endotracheal intubation and surgery, admitting in Shahid Rajaei and Velayat hospitals of Qazvin. Patients divide into four groups (A, B, C, and D), randomly. Induction of anesthesia include; Fentanyl (1 microgram per kilogram) plus Midazolm (0/02 milligram per kilogram), and after two minutes, Nesdonal (5 milligram per kilogram) plus Atracurium (0/5 milligram per kilogram). In addition to induce the routine anesthesia; Group A, receive distilled water.Distilled water is placebo. Group B receive intravenous Lidocaine (1/5 milligram per kilogram), group C receive intravenous Rapifen (10 microgram per kilogram), and group D receive intravenous Lidocaine (1/5 milligram per kilogram) plus Rapifen (10 microgram per kilogram), 1/5 minutes before laryngoscopy and intubation. In each group, blood pressure and heart rate measure before sedation & induction, and 20 seconds & 5 minutes after laryngoscopy, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042117373N1
Registration date: 2014-10-20, 1393/07/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-20, 1393/07/28
Registrant information
Name
Kambiz Boroojli
Name of organization / entity
Qazvin University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 5800
Email address
kboroojli@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Siences, Shahid Rajaie and Velayat hospitals
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effect of intravenous Rapifen and Lidocaine to control hemodynamic responses in laryngoscopy and intubation
Public title
To compare the effect of intravenous Rapifen and Lidocaine to control hemodynamic responses in laryngoscopy and intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclsion criteria:patients with 15 years old to 60 years old . Exclusion criteria: addiction ؛ patients with heart disease ؛ respiratory diease ؛ hypertension( >140/90) ؛ chronic dease with giving analgesic drugs ؛ pregnancy
Age
From 15 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Siences
Street address
Bahonar street , Qazvin University of Medical Siences
City
Qazvin
Postal code
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
28/20/8498

Health conditions studied

1

Description of health condition studied
General anesthesia
ICD-10 code
T 88.5
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Blood pressure
Timepoint
Before sedation , before induction , 20 s after laryngoscopy , 5 minutes after laryngoscopy
Method of measurement
Blood pressure measurement divice

2

Description
Heart rate
Timepoint
Berore sedation , before induction , 20 s after laryngoscopy , 5 minutes after laryngoscopy
Method of measurement
Monitoring of heart rate divice

Secondary outcomes

empty

Intervention groups

1

Description
In group A, patients receive routine anesthesia, and distilled water 1.5 minutes before laryngoscopy and intubation .Distilled water is placebo.
Category
Treatment - Drugs

2

Description
In addition to induce routine anesthesia; patients in group B receive intravenous Lidocaine (1.5 milligram per kilogram) 1.5 minutes before laryngoscopy and intubation
Category
Treatment - Drugs

3

Description
In addition to induce routine anesthesia; patients in group C receive intravenous Rapifen (10 microgram per kilogram) 1.5 minutes before laryngoscopy and intubation
Category
Treatment - Drugs

4

Description
In addition to induce routine anesthesia; patients in group D receive intravenous Lidocaine (1.5 milligram per kilogram) plus Rapifen (10 microgram per kilogram) 1.5 minutes before laryngoscopy and intubation
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin University of Medical Siences , Velayat hospital
Full name of responsible person
Kambiz Boroojli
Street address
Elahieh street , 22 bahman street , Taavon square , Qazvin
City
Qavin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Siences
Full name of responsible person
Kambiz Boroojli
Street address
Elahieh street , 22 bahman street , Taavon square , Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Siences
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
Qazvin University of Medical Siences
Full name of responsible person
Kambiz Boroojli
Position
Anesthesia resident
Other areas of specialty/work
Street address
Elahieh street , 22 bahman street , Taavon square , Qazvin
City
Qazvin
Postal code
Phone
+98 28033790620
Fax
+98 33790611
Email
kboroojli@qums.ac.ir
Web page address
hosvelayat.qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Siences , Velayat hospital
Full name of responsible person
Alli Alizadeh
Position
Attend of anesthesia
Other areas of specialty/work
Street address
Elahieh street , 22 bahman street , Taavon square , Qazvin
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
+98 33790611
Email
alializadeh@yahoo.com
Web page address
hosvelayat.qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Siences , Velayat hospital
Full name of responsible person
Kambiz Boroojli
Position
Anesthesia resident
Other areas of specialty/work
Street address
Elahieh street , 22 bahman street , Taavon square , Qazvin
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
+98 33790611
Email
kboroojli@qums.ac.ir
Web page address
hosvelayat.qums.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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