This research will be conducted to determine the effect of low dose- ketamine during anaesthesia induction in painful ophthalmic surgery: quantity of intraoperative and postoperative analgesic requirement, postoperative nausea, vomiting and pain. Inclusion criteria:every women and men under surgery of Strabismus,Retinal Detachment,Keratoplasty; have no contraindication of ketamine;have no addiction to drugs;ASAof patient are 1 and2.Exclusion criteria:every women and men under surgery of Strabismus,Retinal Detachment,Keratoplasty less than 18 years and older than 80years;have contraindication of ketamine for exp:increased ICP and IOP.Ischemic heart aneurysms.Psychiatric disease such as schizophrenia.open eye.Target sample size is 88 patients.pateints will be randomly selected that under surgery of Strabismus,Retinal Detachment,Keratoplastyin in Ophthalmology operating room of Esfahan's Fayz hospital in 2010-2011. patients will be randomly divided in 2 groups(case,control).each of the three are equally distributed in 2 groups(case,control). patients of case group during anesthesia induction in addition of anesthtic drugs infuse 0.5mg/kg ketamine intravenouse.patients of control group infuse the same volume of saline normal.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102235889N1
Registration date:2011-12-15, 1390/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-15, 1390/09/24
Registrant information
Name
Hasanali Soltani
Name of organization / entity
Anesthetic and Special Cares Group of Esfahan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5555
Email address
soltani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of ketamine that is used in addition to other anesthesia drugs is the responsibility of the researcher
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effect of low dose- ketamine during anesthesia induction in 18-80 years pateint under surgery :Strabismus,Retinal Detachment,Keratoplasty
Public title
analgesic effect of ketamine in painful ophthalmic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:every women and men under surgery of Strabismus,Retinal Detachment,Keratoplasty .Exclusion criteria:every women and men under surgery of Strabismus,Retinal Detachment,Keratoplasty less than 18 years and older than 80years;have contraindication of ketamine for exp:increased ICP and IOP.Ischemic heart aneurysms.Psychiatric disease such as schizophrenia.open eye injury;addict to drugs;ASAof patient are not 1 and2;any changese in anesthetic plan that cause the use of drugs other than usual;any changese in surgical plan that cause changese in anesthetic plan;any changese in conditions of during surgery that cause changes in anesthesia drugs
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Regional Bioethics Committee in medical reaserches of Medical University of Esfahan
Street address
Unit VICE-Chancellory for research and technology, Medical university of Esfahan, Esfahan
City
Esfahan
Postal code
81745319
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
189066
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
H57.1
ICD-10 code description
Ocular pain
2
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
the intensity of pain
Timepoint
after the patient's full consciousness in recovery
Method of measurement
according on VAS(0-10)
2
Description
the intensity of nausea
Timepoint
after the patient's full consciousness in recovery
Method of measurement
according on VAS(0-10)
3
Description
vomiting frequency
Timepoint
in recovery if there is vomiting
Method of measurement
counting vomiting frequency in recovery
Secondary outcomes
1
Description
maxium of anasthetic drug
Timepoint
per 5 minutes until maxium 150microgeram per kg per minutes
Method of measurement
microgeram per kg per minutes untill reaching to 80-100% systolic BloodPressure before surgery
2
Description
maxuim of analgesic during operation
Timepoint
per 10 minutes
Method of measurement
microgeram per kg untill reaching to 80-100% systolic BloodPressure before surgery
3
Description
time interval between end of surgery till extubation
Timepoint
end of surgery till extubation
Method of measurement
Presence of spontaneous breathing of pationt with The minimum of normal tidal volume
4
Description
analgesic requirement in recovery
Timepoint
after the patient's full consciousness in recovery
Method of measurement
microgeram per kg if VAS=4.bigger than4
5
Description
period of time staying in recovery
Timepoint
when paition discharge of recovery
Method of measurement
acourding on patient's conditions of discharge in terms of minutes
6
Description
the duration of surgery
Timepoint
time of starting surgery till end of surgery
Method of measurement
in terms of minutes
7
Description
mean blood pressure
Timepoint
per 5 min
Method of measurement
in terms of mmhg by blood pressure monitoring device
8
Description
pulse
Timepoint
per 5 min
Method of measurement
per minutes by pulse monitoring device
9
Description
age
Timepoint
before surgery write in Questionnaire
Method of measurement
years
10
Description
sex
Timepoint
before surgery write in Questionnaire
Method of measurement
female-male
11
Description
weight
Timepoint
before surgery write in Questionnaire
Method of measurement
kg-by Balance
12
Description
Underlying disease
Timepoint
before surgery write in Questionnaire
Method of measurement
Underlying disease:have.not have
Intervention groups
1
Description
Intervention:ketamine,0.5mg/kg during anaesthesia induction received intravenous
Category
Treatment - Drugs
2
Description
control:normal salin, 0.5mg/kg during anaesthesia induction received intravenous
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fayz Hospital
Full name of responsible person
Mitra Abdollahi,medical student,general physician
Street address
Fayz Hospital, Ghods ST., Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
no sponsor
Full name of responsible person
no sponsor
Street address
Esfahan Medical University
City
Esfahan
Grant name
-
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
no sponsor
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
Islamic Azad Medical University of Najafabad
Full name of responsible person
Mitra Abdollahi
Position
Medical student-General Physician
Other areas of specialty/work
Street address
Islamic Azad Medical University of Najafabad,Najafabad
City
Esfahan
Postal code
Phone
+98 983312291111
Fax
Email
mitra.abdolahi@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthetic and Special Cares Group of Esfahan Medical University
Full name of responsible person
Dr. Hasanali Soltani
Position
Specialist of Anesthetic and Special Cares
Other areas of specialty/work
Street address
Unit of Anesthetic and Special Cares Group of Esfahan Medical University,Basement floor, Alzahra Hospital,Esfahan
City
Esfahan
Postal code
Phone
+98 31 1668 5555
Fax
+98 31 1668 5555
Email
soltani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthetic and Special Cares Group of Esfahan Medical University
Full name of responsible person
Dr. Hasanali Soltani
Position
Specialist of Anesthetic and Special Cares
Other areas of specialty/work
Street address
Unit of Anesthetic and Special Cares Group of Esfahan Medical University,Basement floor, Alzahra Hospital,Esfahan
City
Esfahan
Postal code
Phone
+98 31 1668 5555
Fax
+98 31 1668 5555
Email
soltani@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)