Ninety consecutive patients with ASA I, II who were candidate for cataract surgery were studied in a double blind randomized clinical trial. Patients' age range was 20-60 years. Patients with the history of heart blocks, taking anti IOP drugs and the ones who needed general anesthesia were excluded from the study. Patients were divided into two groups randomly. All patients received Sufentanyle 0.15 Mic/kg, 5 min before the operation and then their IOP were measured. Patients in group A received Lidocaine 2mg/kg, and IOP was measured 3min after the Lidocaine injection. Group B received placebo as the same way. Patients' heart rate, blood pressure and SPO2 were measured either.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811082946N2
Registration date:2010-01-28, 1388/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-28, 1388/11/08
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-01-02, 1388/10/12
Expected recruitment end date
2010-04-02, 1389/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of intravenous lidocaine on intra ocular pressure in cataract surgical patients under sedation
Public title
Study the effect of intravenous lidocaine on Intra ocular pressure during cataract surgery while patients are given sedations
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA I, II who were candidate for cataract surgery. Exclusion criteria: patients with history of heart blocks, taking anti IOP drugs and the ones who needed general anesthesia.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
#2 building of medical university, shahid beheshti boulevard
City
Kermanshah
Postal code
6714415333
Approval date
2009-12-25, 1388/10/04
Ethics committee reference number
A/33917/j/25
Health conditions studied
1
Description of health condition studied
cataract surgery
ICD-10 code
H43.9
ICD-10 code description
Disorder of vitreous body, unspecified
Primary outcomes
1
Description
Intraocular pressure (IOP)
Timepoint
5 min before the operation and 3 min after injecting Lidocaine or placebo
Method of measurement
using Tonometer PT100 model protable non contact
Secondary outcomes
1
Description
patients' heart rate, blood pressure and SPO2
Timepoint
5 min before the operation and 3 min after injecting Lidocaine or the placebo