Objectives:
In the present study we compare the usage of two methods for intubation (direct intratracheal intubation and laryngeal mask) to find the method with less hemodynamic effects in patients under general anesthesia.
Design:
In this clinical trial 200 patients who are candidate for surgery under general anesthesia will be randomly divided into two groups; the control group and the trial group (each group has 100 members).
Setting and conduct:
The patients in the control group will be intubated using direct intratracheal method after initiating general anesthesia and the patients in the trial group will be intubated using laryngeal mask after initiating general anesthesia. The types and dosage of anesthetic drugs are the same in both groups.
Major Inclusion and Exclusion criteria:
Patients who are candidate for surgery under general anesthesia with ASA class 1 in NPO condition, with neither urgent circumstances nor underline diseases.
Intervention:
Direct intratracheal intubation or laryngeal mask.
Main outcome measures (variables):
Mean heart rate, systolic blood pressure, diastolic blood pressure and arterial blood pressure before and after intubation will be compared with each other in the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110619037N3
Registration date:2014-11-17, 1393/08/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-17, 1393/08/26
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Hemodynamic Changes in Usage of Direct Intratracheal Intubation and Laryngeal Mask in Patients under General Anesthesia
Public title
Comparison of the Hemodynamic Changes in Usage of Intratracheal Intubation and Laryngeal Mask in Patients under Anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 20 to 50 years of age who are candidate for surgery under general anesthesia and are in ASA class 1 (The American Society of Anesthesiologists Physical Status classification system): Normal healthy patients with no organic, physiologic, or psychiatric disturbance.
Exclusion criteria:
Patients who use anti-hypertensive, analgesic or sedative agents; patients who need urgent intubation; patients who are not NPO (nil per os); difficult intubation; diabetic patients.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients who enter the trial will be randomly selected for each groups of the study by Random Allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-06-12, 1393/03/22
Ethics committee reference number
28.20.8855
Health conditions studied
1
Description of health condition studied
Heart rate instability due to intubation
ICD-10 code
-
ICD-10 code description
-
2
Description of health condition studied
Blood pressure instability due to intubation
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Mean heart rate
Timepoint
1 minute before intubation and 1, 2, 3, 4, 5 and 10 minutes after intubation
Method of measurement
The monitor device
2
Description
Mean systolic blood pressure
Timepoint
1 minute before intubation and 1, 2, 3, 4, 5 and 10 minutes after intubation
Method of measurement
The monitor device
3
Description
Mean diastolic blood pressure
Timepoint
1 minute before intubation and 1, 2, 3, 4, 5 and 10 minutes after intubation
Method of measurement
The monitor device
4
Description
Mean arterial blood pressure
Timepoint
1 minute before intubation and 1, 2, 3, 4, 5 and 10 minutes after intubation
Method of measurement
The monitor device
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
First intervention group:
Using of intubation tube for direct intubation from SUPA company, Iran, registered No. 24422
Category
Other
2
Description
Second intervention group:
Using of laryngeal maskfor intubation from Cerdas Seimbang Sdn. Bhd. company, Malaysia, registered No. 130601
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat General Hospital
Full name of responsible person
Dr. Mahdi Ebtehaj
Street address
Taavon Square
City
Qazvin
2
Recruitment center
Name of recruitment center
Shahid Rajayi Hospital
Full name of responsible person
Dr. Mahdi Ebtehaj
Street address
Padegan Street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Elaheh Kosari
Street address
Velayat Hospital, Taavon Square
City
Qazvin
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Velayat Hospital
Full name of responsible person
Dr. Elaheh Kosari
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
kosari1377@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)