Hemodynamic responses to intubation in hypertensive patients: Comparison of two methods: direct laryngoscopy by macintosh blade and indirect laryngoscopy by glydioscope
Objectives: this study has been designed to evaluate hemodynamic responses of tracheal intubation by two different methods in hypertensive patients.
Design: single blinded randomized clinical trial
Inclusion criteria: diagnosed hypertension with at least two weeks of treatment before surgery; BP less than 180/110 mmHg before surgery; no ischemic heart diseases; no renal or neurologic involvement.
Exclusion criteria: obesity over 30%above ideal body weight; difficult airway; history of gastrointestinal disease; functional class III, IV according to American Heart Association classification.
Main outcome measures: heart rate and blood pressure variations during first five minutes of intubation.
Methods: All patients will be fasted from overnight and will receive antihypertensive drugs till 2 hours before surgery. Midazolam 0.1 mg/kg will be administered intramuscularly one hour before surgery. In operating room peripheral venous cannula will be inserted and non invasive monitoring of BP, heart rate, ECG, pulseoxymetry and capnography will be stabilized. Tracheal intubation by PVC tubes sizes 7-7.5 for females and 8-8.5 for males will be done by an expert anesthesiologist. Choosing of intubation method will be according to computer generated random numbers. Anesthesiologists who will intubate the patients have at least 10 years of experience and over 100 cases of videolaryngoscopic intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903033915N2
Registration date:2011-06-08, 1390/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-08, 1390/03/18
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Tabriz university of medical sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemodynamic responses to intubation in hypertensive patients: Comparison of two methods: direct laryngoscopy by macintosh blade and indirect laryngoscopy by glydioscope
Public title
Hemodynamic responses to intubation in hypertensive patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosed hypertension; drug treatment for at least 2 weeks before surgery; BP less than 180/110 before surgery; no ischemic heart disease; no renal or neurologic involvement.
Exclusion criteria: obesity over 30%above ideal body weight; difficult airway patients; history of gastrointestinal disease; functional class III, IV according to American Heart Association classification.
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:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee,Tabriz university of medical sciences
Street address
Gholghasht street
City
Tabriz
Postal code
Approval date
2010-07-01, 1389/04/10
Ethics committee reference number
2515/4/5
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
blood pressure
Timepoint
every minute till 5 minute after intubation
Method of measurement
non invasive monitoring
2
Description
heart rate
Timepoint
every minute till 5 minute after intubation
Method of measurement
non invasive monitoring
Secondary outcomes
empty
Intervention groups
1
Description
After stabilization of standard monitoring and administration of isotonic crystalloid 3-5 ml/kg, all patients will pre oxygenated with 100% oxygen for five minutes. Same induction of anesthesia with fentanil 2micg/kg, propofol 2mg/kg and cisatracurium 0.15mg/kg will be induced for all patients. For intervention group specific gladioscope stylet will be lubricated and inserted inside endotracheal tube. Indirect laryngoscopy and tracheal intubation will be done by video laryngoscope.
Category
Other
2
Description
For control group standard direct laryngoscopy by Macintosh with appropriate blade size will be done .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ali Peirovifar
Street address
Operatin Room, Emam Reza Hospital, Ghoghasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Vice chancellor for research,Tabriz University of Medical Sciences, Gholghash street
City
Tabriz
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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor
Other areas of specialty/work
Street address
Operation Room, Emam Reza Hospital, Gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
peirovifara@yahoo.com; peirovifara@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor
Other areas of specialty/work
Street address
Operation Room, Emam Reza Hospital, Ghlghasht street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
peirovifara@yahoo.com; peirovifara@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor
Other areas of specialty/work
Street address
Operation Room, Emam Reza Hospital, Gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
peirovifara@yahoo.com; peirovifara@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)