Protocol summary

Summary
In this randomized clinical trail, 104 patients who are candidated for elective surgery under general anestheis and tracheal intubation will be enrolled.Inclusion criteria: ASA physical status 1 or 2, Mallampati classification 1 or 2 , Aged between 18 and 60 Baseline BP less than 140/90 , Patients without history of difficult intubation or laryngoscopy , Patients without history of cardiovascular disease, hypertension, diabetes, pulmonary, and other systemic disease as well as cervical spine disease, and GERD , Patients without difficult laryngoscopy or intubation , Body mass index ≤ 30 , without consumption of any drugs effective on blood pressure or heart rate (e.g. betablocker or calcium channel blockers) Exclusion criteria: Patients failed to be ventilated by face mask following induction of anesthesia , Decrease more than 25% in heart rate (HR) and blood pressure (BP) after induction of anesthesia , Decrease in O2 saturation to ≤ 94% during ventilation or intubation , Cormack and Lehane score more than 2 at laryngoscopy , Failed intubation attempt which defined as patients requiring more than one attempt to achieve successful intubation, intubations that require more than 30s to be performed and also need for another person to complete the procedure. All laryngoscopy and intubation procedures will be performed by a single investigator in year 3 of residency.Premedication,oxygenation and then induction of anesthesia will be performed as the same in both groups. one group will be intubated by mackintash laryngoscop and the other group by glidescop(video laryngoscop). Heart rate , systolic and diastolic blood pressure will be recorded at different times before and after intubation. Also thetime need for intubation between 2 groups will be measured and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111264969N4
Registration date: 2011-12-20, 1390/09/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Tehran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
drpournajafian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes between tracheal intubation with Mackintash Laryngoscop and Glidescope
Public title
Comparison of hemodynamic changes between tracheal intubation with Mackintash Laryngoscop and Glidescope
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- ASA physical status 1 or 2 2- Mallampati classification 1 or 2 3- Aged between 18 and 60 4- Baseline BP less than 140/90 5- Patients without history of difficult intubation or laryngoscopy 6- Patients without history of cervical spine disease, GERD, and pulmonary disease 7- Patients without difficult laryngoscopy or intubation. 8- Body mass index ≤ 30 Exclusion criteria: 1- Patients failed to be ventilated by face mask following induction of anesthesia 2- Decrease more than 25% in heart rate (HR) and blood pressure (BP) after induction of anesthesia 3- Decrease in O2 saturation to ≤ 94% during ventilation or intubation 4- Cormack and Lehane score more than 2 at laryngoscopy 5- Failed intubation attempt which defined as patients requiring more than one attempt to achieve successful intubation, intubations that require more than 30s to be performed and also need for another person to complete the procedure. 6- Patients taking antihypertensive or other medications affecting on HR and BP such as β-blockers, and calcium channel blockers
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 104
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
Tehran University of Medical Science
Street address
Next to Milad Tower, Hemmat Highway
City
tehran
Postal code
Approval date
2011-06-25, 1390/04/04
Ethics committee reference number
1356/130/ د

Health conditions studied

1

Description of health condition studied
blood pressure and heart rate changes after tracheal intubation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
systolic blood pressure
Timepoint
every 3 minutes
Method of measurement
automatic

2

Description
diastolic blood pressure
Timepoint
every 3 minutes
Method of measurement
automatic

3

Description
heart rate
Timepoint
every 3 minutes
Method of measurement
puls oxymeter

Secondary outcomes

1

Description
sorethroat
Timepoint
after surgery (recovery room)
Method of measurement
asking the patient and observation

2

Description
horseness
Timepoint
after surgery (recovery room)
Method of measurement
asking the patient and observation

3

Description
intubation time
Timepoint
during intubation
Method of measurement
chronometer

Intervention groups

1

Description
laryngoscopy with mackintash laryngoscop
Category
N/A

2

Description
laryngoscopy with glidescope (video laryngoscop)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Alireza Pournajafian
Street address
Beh Afarin st. Karim Khan Aven.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
shohreh asadi
Street address
Poursina st.- Keshavarz Aven.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Alireza Pournajafian
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin st., karim khan Ave.
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
a-pournajafian@tums.ac.ir alipn78@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Alireza Pournajafian
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin st., karim khan Ave.
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
a-pournajafian@tums.ac.ir alipn78@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
Loading...