Effect of premedication in anesthesia and hemodynamic Dexmedetomidine cataract surgery with local anesthesia and sedation with propofol applied topically
Aim of this study is effect of premedication in anesthesia and hemodynamic Dexmedetomidine cataract surgery with local anesthesia and sedation with Propofol applied topically. This study is a double blind clinical trials. 100 patients with cataract surgery will enter to study. We will divide patients in two groups randomly. We will inject 0.5 microgram per kilogram Dexmedetomidine in intervention group. We will inject normal saline in control group. We will record vital sign before injection of Dexmedetomidine or normal saline and before induction of anesthesia with Propofol and every 5 minute during surgery. We will record time of awake in patients at the end of surgery.
Inclusion criteria: patients with cataract surgery; 45 to 70 years; ASA class I and II. Exclusion criteria: kidney disease; cardiovascular disease; hepatic disease; pulmonary disease; chronic use narcotic and drug and neurological drugs
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050120258N43
Registration date:2017-05-04, 1396/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research , Arak University of Medical Sciences
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of premedication in anesthesia and hemodynamic Dexmedetomidine cataract surgery with local anesthesia and sedation with propofol applied topically
Public title
Effect of premedication in anesthesia and hemodynamic Dexmedetomidine cataract surgery with local anesthesia and sedation with propofol applied topically
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with cataract surgery; 45 to 70 years; ASA class I and II
Exclusion criteria: kidney disease; cardiovascular disease; hepatic disease; pulmonary disease; chronic use narcotic and drug and neurological drugs
Age
From 45 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.ARAKMU.REC.1394.292
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Senile cataract
Primary outcomes
1
Description
Vital sign
Timepoint
before Induction of anesthesia with Propofol and every 5 minute during surgery
Method of measurement
Device
2
Description
time awake patient
Timepoint
in end of surgery discontinuation of Propofol
Method of measurement
minute
Secondary outcomes
empty
Intervention groups
1
Description
control group:We inject normal saline .
Category
Treatment - Drugs
2
Description
Intervention group: We inject 0.5 microgram per kilogram Dexmedetomidine, 10 minute before start surgery in intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Bijan Yazdi
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences