The purpose of this study is evaluation of the use of propofol and thiopental alone and in combination on the ease of placement of laryngeal mask. Persons aged over 15 years who undergo elective surgery without a history of addiction to drugs and deformity of the head and neck that the first attempt succeeded in inserting Laryngeal mask will be enrolled. For this purpose, 138 patients admitted to Valiasr hospital will be divided into 3 groups: propofol in the first group, propofol and thiopental in the second group and thiopental in the third group will be used. The patient's response to the presence or absence of gag, cough, body and head movement and laryngospasm in 30 seconds after entering the laryngeal mask will be evaluated and compared with other groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011512642N11
Registration date:2015-02-11, 1393/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technological Arak University of Medical Sciences
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of the use of propofol and thiopental alone and in combination with the ease of placement of laryngeal mask
Public title
Effects of intravenous anesthesia for laryngeal mask insertion
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: older than 15 years old, elective surgery; No Dentures; BMI<35; No history of addiction to drugs, alcohol; no history of chronic use of sleeping drugs or psychogenic drug; No history of allergies; No deformity of the head and neck
exclusion criteria: Failure to LMA insertion at the first attempt; Lack of consent of Inclusion
Age
From 15 years old to 85 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 for Research and Technology Arak University of Medical Sciences
Street address
Sardasht Square, University Central Building
City
Arak
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
91-141-13
Health conditions studied
1
Description of health condition studied
Laryngeal mask insertion
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Reflex cough
Timepoint
30 seconds after placement of laryngeal mask
Method of measurement
According to see a doctor
2
Description
Heart rate
Timepoint
Before induction, immediately after injection and then every 2 minutes respiration
Method of measurement
By pulse oximetry device
3
Description
blood pressure
Timepoint
Before induction, immediately after injection and then every 2 minutes respiration
Method of measurement
By manometer pressure in millimeters of mercury
Secondary outcomes
1
Description
laryngeal spasm
Timepoint
30 seconds after placement of laryngeal mask
Method of measurement
According to see a doctor
Intervention groups
1
Description
Group 1: Pofol to the 2.5 mg / kg injection and after 30 seconds the laryngeal mask placement
Category
Prevention
2
Description
Group 2: Pofol the amount of 1.25mg / kg and thiopental to the 3.125mg / kg injection and after 30 seconds the laryngeal mask placement
Category
Prevention
3
Description
Group 3: thiopental dose of 6.25g / kg injection and after 30 seconds the laryngeal mask placement
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Valiasr Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Valiasr Square
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technological Arak University of Medical Sciences
Full name of responsible person
Hossein Rafie
Street address
Sardasht Square,University Central Building
City
Arak
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 and Technological Arak 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship subspecialty care
Other areas of specialty/work
Street address
Darabad, Masih Daneshvari Hospital
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship subspecialty care
Other areas of specialty/work
Street address
Darabaad, Masih Daneshvari Hospital
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)