Objectives: The purpose of this study is to compare the combination of propofol with alfentanil or fentanyl on patient eye movement during cataract surgery under topical anesthesia.
Design: Two hundreds and forty six patients candidate for cataract surgery.
Setting and conduct:This is a randomized block, double-blind, without placebo and clinical trial phase II study.
Major inclusion criteria: patients over the age of 18, candidates for cataract surgery
Major exclusion criteria: History of cardiovascular and neuromuscular diseases
Interventions: Patients received 0.3 mg/kg propofol which continued with 0.5 mg/kg/hr propofol. Patients divided in to two groups; group one received intravenous injection of 1 µg/kg fentanyl and in second group patients received intravenous injection of 1 µg/kg alfentanil.
Main outcome measures: eye movement, heart rate, and arterial blood pressure were recorded at minutes 0, 10, and 30 after onset of surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306073289N5
Registration date:2013-08-18, 1392/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Esmail Moshiri
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
dr_moshiri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of propofol with alfentanil and propofol with fentanyl on patient eye movement during cataract surgery under topical anesthesia
Public title
Different anesthetic methods in reducing patient eye movement during cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patient older than 18 years old
Exclusion criteria: History of cardiovascular disease, History of neuromuscular disorder, History of allergic reaction to anesthetic drugs, history of previous surgery on eye
Age
From 18 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
246
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2013-05-12, 1392/02/22
Ethics committee reference number
92-144-6
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H25
ICD-10 code description
cataract Excluded: capsular glaucoma with pseudo exfoliation of lens
Primary outcomes
1
Description
Amount of eye movement
Timepoint
At time 0, 10 and 30 after beginning surgery
Method of measurement
quality grading
Secondary outcomes
1
Description
Blood pressure
Timepoint
At time 0, 10 and 30 minutes after beginning surgery.
Method of measurement
Mercury sphygmomanometer according to mmHg
2
Description
Heart rate
Timepoint
At time 0, 10 and 30 minutes after beginning surgery.
Method of measurement
beat per minute
3
Description
temperature
Timepoint
At time 0, 10 and 30 minutes after beginning surgery.
Method of measurement
Mercury Termometer
Intervention groups
1
Description
Propofol 1%, made in Dongkook Pharma. Co. Ltd. South Korea, 0.3 mg/kg that is used in IV injection one time for anesthesia induction
Category
Other
2
Description
Propofol 1%, made in Dongkook Pharma. Co. Ltd. South Korea, 0.5 mg/kg/hr IV infusion
Category
Other
3
Description
Intervention 1. Fentanyl (feniject), made in Aburaihan Pharma. Co. Iran, 1 µg/kg IV injection.
Category
Treatment - Drugs
4
Description
Intervention 2. Alfentanil, made in Hameln pharmaceuticals. Co. Ltd. Germany, 1 µg/kg IV injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Esmaeil Moshiri
Street address
Amirkabir Hospital. Parastar square. Arak. Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice Chancellor for Research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences,Vice Chancellor for Research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaiel Moshiri
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Amirkabir Hospital. Parastar square.Arak. Iran
City
Arak
Postal code
Phone
+98 86 1223 1104
Fax
Email
dr_moshiri@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaiel Moshiri
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Amirkabir Hospital. Parastar square. Arak. Iran
City
Arak
Postal code
Phone
+98 86 1223 1104
Fax
Email
dr_moshiri@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeil Moshiri
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Amirkabir Hospital. Parastar square. Arak. Iran
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)