A Comparison and Evaluation of intra ocular pressure following intubation with Mccoy, Macintosh and video laryngoscope (Glide scope) in patients with cataract surgery.
Our general objective in this study is assessing intraocular pressure (IOP) changes after intubation with three types of laryngoscope (McCoy, Macintosh and video laryngoscope or Glidescope). This is a double blind and prospective clinical trial on 180 patients subjected to cataract surgery in Shafa Hospital. Inclusion criteria are: patients who are admitted for elective cataract surgery, age: 20-70 year and have ASA classification as 1 or 2. Exclusion criteria are: history of alcohol and drug abuse, antihypertensive and cardiovascular medicines usage, glaucoma eye drop usage, diabetes and open eye injuries. The patients will be divided into three groups. Induction of anesthesia in all patients is similar. Just after induction and before intubation, intraocular pressure (IOP) will be measured by means of Schiotz tonometer. Then intubation will be done by Mccoy laryngoscope in group A, Macintosh laryngoscope in group B and glidescope in group C. After intubation IOP is measured again and anesthesia is maintained on Isoflurane. IOP is measured again five minutes later. Collected data will be analyzed by Repeated Measures ANOVA test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301079585N3
Registration date:2013-02-21, 1391/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-21, 1391/12/03
Registrant information
Name
Ali Barkhori
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5803
Email address
a_barkhori@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison and Evaluation of intra ocular pressure following intubation with Mccoy, Macintosh and video laryngoscope (Glide scope) in patients with cataract surgery.
Public title
Evaluation of intra ocular pressure following intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: patients who are admitted for elective cataract surgery, age: 20-70 and have ASA classification as 1 or 2. Exclusion criteria are: history of alcohol and drug abuse, antihypertensive and cardiovascular medicines usage, glaucoma eye drop usage, diabetes and open eye injuries.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All patients will sign informed consent and they will be divided into three groups by means of random numbers table. Intubation is done by an anesthesiologist and the resident of anesthesiology who is blind to the kind of laryngoscope will obtain IOP, heart rate and blood pressure. Moreover the patients are unaware of the kind of used laryngoscope.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnic Committee of Kerman University of Medical Sciences
Street address
Jomhoori Boulevard
City
Kerman
Postal code
Approval date
2012-04-17, 1391/01/29
Ethics committee reference number
k/91/02
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H26.9
ICD-10 code description
Cataract, unspecified
Primary outcomes
1
Description
intra ocular pressure
Timepoint
before and after intubation, and 5 minutes later
Method of measurement
Schiotz tonometer
Secondary outcomes
1
Description
Mean Arterial Pressure
Timepoint
Before and after intervention and every 5 minutes during operation
Method of measurement
mmhg / by electronic monitoring
2
Description
Heart Rate
Timepoint
Before and after intervention and every 5 minutes during operation
Method of measurement
electronic monitoring
Intervention groups
1
Description
Intubation by Mccoy laryngoscope made by Riester company of Germany, after induction of anesthesia.
Category
Treatment - Devices
2
Description
Intubation by Macintosh laryngoscope made by Riester company of Germany, after induction of anesthesia.
Category
Treatment - Devices
3
Description
Intubation by glidescope made by Verathon® Medical (Canada) ULC, after induction of anesthesia.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
ُShafa Hospital
Full name of responsible person
Zahra Asskari
Street address
Shafa Hospital, Shafa Street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Syavash Moradi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kerman Bahonar Hospital, Baghmelli Square
City
Kerman
Postal code
7613747181
Phone
+98 34 1226 3815
Fax
Email
javakrd34@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Khosro Zamiri
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Kerman Shafa Hospital, Shafa Street
City
Kerman
Postal code
Phone
+98 34 1211 5814
Fax
Email
dr.zamiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Syavash Moradi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kerman Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1211 5814
Fax
Email
javakrd34@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)