Compare of Endotracheal Intubation and I-gel or LMA Insertion on Intraocular Pressure and Hemodynamic Response and Post op Nausea and Vomiting in Pediatric Patients Who Receive Propofol and Remifentanil during Strabismus Surgery.
Objective: To determine the effect of endotracheal intubation or I-gel or LMA on intraocular pressure and hemodynamic response and postoperative nausea and vomiting in children who relieved propofol and remifentanil during surgery for strabismus
Study design: randomized single blind clinical trial.
Inclusion criteria:
3 to 8 years old; undergoing strabismus surgery; at least 6 hours NPO before surgery.
Exclusion criteria:
Glaucoma; a history of previous intraocular surgery; heart disease; lung disease ; diabetes; body mass index more than 35; limited mouth opening, mouth and larynx anatomical and pathological defects; possibility of regurgitation; airway obstruction.
Method: 90 patients randomly divided into three groups of 30 endotracheal intubation and I-gel and LMA group. Sedation is with oral administration of midazolam 0.33 mg /kg , while anesthesia induced by 1 mg/ kg propofol, 1 µg/kg remifentanil and 0.4 mg atracurium. Intraocular pressure by an eye specialist is measured by using the Tono pen device.
At the same time hemodynamic variables: systolic blood pressures, diastolic blood pressure and heart rate are recorded.
3 minutes after induction endotracheal intubation or insertion of I-gel or LMA will be performed.
And at 0, 2 and 5 minutes after intubation intraocular pressure are measured and recorded.
After extubation, postoperative nausea and vomiting during recovery time are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040319470N54
Registration date:2017-05-13, 1396/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-13, 1396/02/23
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of Endotracheal Intubation and I-gel or LMA Insertion on Intraocular Pressure and Hemodynamic Response and Post op Nausea and Vomiting in Pediatric Patients Who Receive Propofol and Remifentanil during Strabismus Surgery.
Public title
Compare of Endotracheal Intubation and I-gel or LMA Insertion on Intraocular Pressure and Hemodynamic Response and Post op Nausea and Vomiting in Pediatric Patients Who Receive Propofol and Remifentanil during Strabismus Surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
3 to 8 years old; undergoing strabismus surgery; at least 6 hours NPO before surgery.
Exclusion criteria:
Glaucoma; a history of previous intraocular surgery; heart disease; lung disease ; diabetes; body mass index more than 35; limited mouth opening, mouth and larynx anatomical and pathological defects; possibility of regurgitation; airway obstruction.
Age
From 3 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.SUMS.MED.REC.1395.64
Health conditions studied
1
Description of health condition studied
Strabismus
ICD-10 code
H50
ICD-10 code description
Other strabismus
Primary outcomes
1
Description
Intra occular pressure
Timepoint
every 0, 2, 5 minutes after inserion of airway decices
Method of measurement
tono pen
Secondary outcomes
1
Description
blood pressure
Timepoint
at 0,2 and 5 minutes after insrtion of airway devices
Method of measurement
Sphygmomanometer
2
Description
Heart rate
Timepoint
at 0,2 and 5 minutes after insrtion of airway devices
Method of measurement
pulsoximeter
3
Description
Nausea and Vomiting
Timepoint
at 0,2 and 5 minutes after insrtion of airway devices
Method of measurement
observasion
Intervention groups
1
Description
Intervention group 1: endotracheal tube used for airway management.
Category
Prevention
2
Description
Interventions group two: I-gel used for airway management.
Category
Prevention
3
Description
Interventions group three: LMA used for airway management.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Hamed Zarei
Street address
Khalili Hospital, Khalili Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Zarei
Position
anesthesiology resident/physician
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
zarei.hamed@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Elahe Alahyari
Position
Cardio-anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
allahyary.elahe@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)