Protocol summary

Summary
(1) Objective: To assess the use of lubricant gel and lidocaine gel during placement of laryngeal mask on Hemodynamic changes and emergence reactions of anesthesia in patients (2) Design: This study is a clinical double blind trial and will be done in all 60 -20 years old patients with ASA class I who admitted to Army hospital for varicocelectomy surgery. (3) how to do: All patients were anesthetized with a similar general anesthesia( 5 ml per kg liquid then injection of 4 micro grams per kg of fentanyl and 0.5 mg per kg atracurium and 5 mg for every kg of sodium thiopental). And maintenance of anesthesia was done by mask and using nitrous oxide and 50% oxygen and 5 mg per kg per hour propofol. (4)Inclusion criteria: Male patients, aged 20 to 60 years; ASA I; varicocelectomy with general anesthesia; completing consciously the consent form to participate in research projects. Exclusion criteria: Over 60 years old; ASA class II ,III and IV; a history of sore throat and lung disease; drug addiction; any heart disease - liver -Kidney; allergic to any medicine. (5) Interventions: use of lidocaine gel during insertion of laryngeal mask (6) The main outcome variables: lidocaine gel during insertion of laryngeal mask can be affected in intraoperative hemodynamic changes and frequency of emergence reactions from anesthesia.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011716906N2
Registration date: 2016-05-11, 1395/02/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-11, 1395/02/22
Registrant information
Name
Behzad Kazemi Haki
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 938 0765
Email address
behzad_emt@yahoo.com
Recruitment status
Recruitment complete
Funding source
Army University of Medical Science
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-06-23, 1392/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the use of lubricant gel and lidocaine gel during the placement of LAM (Laryngeal Mask Airway) on hemodynamics and symptoms of withdrawal reactions in the patients out of anesthesia in 501 Army hospital
Public title
Comparison of the use of lubricant gel and lidocaine gel in the placement of laryngeal mask on Hemodynamic and reactions in the patients out of anesthesia in 501 Army hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Male patients, aged 20 to 60 years; ASA I; varicocelectomy with general anesthesia; completing consciously the consent form to participate in research projects. Exclusion criteria: Over 60 years old; ASA class II ,III and IV; a history of sore throat and lung disease; drug addiction; any heart disease - liver -Kidney; allergic to any medicine.
Age
From 20 years old to 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Army University of Medical Sciences
Street address
Martyr Etemadzadeh Street, West Fatemi Avenue
City
Tehran
Postal code
1411718541
Approval date
2013-01-09, 1391/10/20
Ethics committee reference number
9111

Health conditions studied

1

Description of health condition studied
Varicocele
ICD-10 code
I86.1
ICD-10 code description
Varicocele

Primary outcomes

1

Description
blood pressure
Timepoint
evry 5 minutes, before, in during and after itervention
Method of measurement
By using blood pressure measuring equipment

2

Description
heart beat
Timepoint
evry 2 minutes. before, in during and after intervention
Method of measurement
By using ECG monitoring

3

Description
weight
Timepoint
after intervention
Method of measurement
Based on individual weighing with standard scales

4

Description
nauesa and vomiting
Timepoint
before, in during and after intervention
Method of measurement
View raising or attempting to raise involuntary stomach contents

5

Description
Sore throat
Timepoint
befor and after intervention
Method of measurement
ask the patient

6

Description
Cough
Timepoint
before and after intervention
Method of measurement
observation

7

Description
age
Timepoint
before intervention
Method of measurement
By date of birth (birth certificate)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group The use of lidocaine gel during insertion of laryngeal mask the extent one inch or 2.5 cm
Category
Treatment - Drugs

2

Description
control group The use of lubricant gel during insertion of laryngeal mask the extent one inch or 2.5 cm
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital of Army university of medical sciences
Full name of responsible person
Mohammad Reza Rafiee
Street address
Martyr Etemadzadeh Street, West Fatemi Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Army University of Medical Sciences
Full name of responsible person
Banafshe Dormanesh
Street address
Martyr Etemadzadeh Street, West Fatemi Avenue - Deputy of research and technology
City
Tehran
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, Army University of Medical Sciences
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
Urmia University of Medical Sciences
Full name of responsible person
Behzad Kazemi Haki
Position
Inventor and Researcher
Other areas of specialty/work
Street address
Department of Anesthesia, Operating Room Ward of Imam Khomeini hospital of Mahabad
City
Mahabad
Postal code
591375481
Phone
+98 44 4222 5779
Fax
Email
behzad_emt@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Mohammad Reza Rafiee
Position
asociated professor of anesthesia
Other areas of specialty/work
Street address
martyr Etemadzadeh Street, West Fatemi Avenue, Army University of Medical Sciences
City
Tehran
Postal code
1411718541
Phone
+98 21 8595 2959
Fax
+98 21 8833 7909
Email
info@ajaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Behzad Kazemi Haki
Position
Inventor and Researcher
Other areas of specialty/work
Street address
Department of anesthesia, Operation room ward, Mahabad Imam Khomeini hospital
City
Mahabad
Postal code
591375481
Phone
+98 44 4222 5779
Fax
Email
behzad_emt@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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