Objective: To evaluate the effect of Nitrous Oxide on Pupillary diameter in cataract surgery under general anesthesia.
Study design: randomized prospective, interventional, double blind clinical trial.
Inclusion criteria: Forty patients with cataract50 to 80 year- old; ASA 1 or 2.
Exclusion criteria: patients with obesity (BMI >30); blood pressure above 160/90 mmHg; glaucoma, pseudo exfoliation pupillary adhesions; optical trauma; clear corneal opacity (Leucoma); diabetes and endotracheal intubation more than 30 seconds.
Interventions: Forty patients with cataract, scheduled for operation under general anesthesia were randomly allocated in two groups. After induction of anesthesia, it was maintained with Isoflurane and nitrous oxide oxygen (60%-40%) in group"1" versus oxygen 100% in group "2".
Pupillary diameter was measured by pupillometer (Colvard Pupillometer manufactured by OASIS, United States) and blood pressure and heart rate will be measure and recorded at 4 time points( before anesthesia induction, before endotracheal intubation, one and five minutes after intubation).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071319470N34
Registration date:2016-10-20, 1395/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-20, 1395/07/29
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
2013-03-10, 1391/12/20
Expected recruitment end date
2013-09-11, 1392/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pupillary Response to Nitrous Oxide Administration in Cataract Surgery under General Anesthesia
Public title
Pupillary Response to Nitrous Oxide Administration in Cataract Surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Forty patients with cataract50 to 80 year- old; ASA 1 or 2.
Exclusion criteria: patients with obesity (BMI >30); blood pressure above 160/90 mmHg; glaucoma, pseudo exfoliation pupillary adhesions; optical trauma; clear corneal opacity (Leucoma); diabetes and endotracheal intubation more than 30 seconds
Age
From 50 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CT-P-91-5274
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25.0
ICD-10 code description
Senile incipient cataract
Primary outcomes
1
Description
Pupillary diameter measurment
Timepoint
before anesthesia induction, before endotracheal intubation, one and five minutes after intubation
Method of measurement
by pupillometer (Colvard Pupillometer manufactured by OASIS, United States)
Secondary outcomes
1
Description
blood pressure
Timepoint
before anesthesia induction, before endotracheal intubation, one and five minutes after intubation
Method of measurement
Sphygmomanometer
2
Description
heart rate
Timepoint
before anesthesia induction, before endotracheal intubation, one and five minutes after intubation
Method of measurement
pulsoximeter
Intervention groups
1
Description
Intervention group: After induction of anesthesia, anesthesia is maintained with Isoflurane and nitrous oxide oxygen (60%-40%) in intervention group.
Category
Diagnosis
2
Description
Control group: After induction of anesthesia oxygen 100% was administered in control group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Mnsoor Masjedi
Street address
Khalili Hospital, Khalili Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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 streetl
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Alireza GhANBARI
Position
Anesthesia Nurse
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 36474270
Fax
Email
alinurse1371@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Mansoor Masjedi
Position
Anesthesilogist, ICU fellow ship
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
mansoormasjedi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz anesthesiology and critical care research center
Full name of responsible person
Farzaneh Masihi
Position
English Consultant
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Research Tower, 5 th floor, 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)