Goal:
Comparing of the effects of Dexmedetomidine and Remifentanyl sedation on cognition in mustard gas veterans under cataract surgery.
Objectives:
1- Determine and comparing Heart rate in the two groups
2- Determine and comparing Blood pressure in the two groups
3- Determine and comparing SPO2 in the two groups
4- Determine and comparing Cognition state in the two groups
A double blind randomized clinical trial study in Labbafinejad hospital on 100 mustard gas veterans who are candidate for topical cataract surgery. The Inclusion criteria are
Inclusion criteria: Age between 40 to 70 years old; ASA Class Iⅈ Mustard gas veterans under topical cataract surgery
Exclusion criteria: Nausea and Vomiting more than 3times; Surgery time more than 120min; Any problem with the medicine protocol; initial MMSE score less than 23; Heart rate less than 45
Sample: 100 Patients
Intervention:
Group #1: Dexemedetomidine (0.5µg/kg) as a bolus dose in 10 minutes slowly and 5 minutes before topical anesthesia. The infusion dose was administered by 0.2 µg/kg/hr.
Group #2: Remifentanil (0.1µg/kg) as a bolus dose in 10 minutes slowly and 5 minutes before topical anesthesia. The infusion dose was administered 0.05 µg/kg/min.
Finally, we will compare the effects of Dexemedetomidine and Remifentanil on HR, BP, SPO2 and Cognition state.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082710678N1
Registration date:2016-02-01, 1394/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Mahtab Poor zamany nejat kermany
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 9029
Email address
drmpoorzamani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor in Research Affairs of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Dexmedetomidine and Remifentanyl sedation on cognition in mustard gas veterans under cataract surgery
Public title
effects of Dexmedetomidine and Remifentanyl sedation on cognition
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Age between 40 to 70 years old; ASA Class Iⅈ Mustard gas veterans under topical cataract surgery
Exclusion criteria: Nausea and Vomiting more than 3times; Surgery time more than 120min; Any problem with the medicine protocol; initial MMSE score less than 23; Heart rate less than 45
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice- Chancellor in Research Affairs, Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin
City
Tehran
Postal code
198396-3113
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
sbmu.rec.1393.348
Health conditions studied
1
Description of health condition studied
cognition
ICD-10 code
R41
ICD-10 code description
Other symptoms and signs involving cognitive functions and awareness
Primary outcomes
1
Description
Heart rate
Timepoint
Just befor injection the anesthetic agents then every 5 minutes during the surgery
Method of measurement
ECG Monitoring
2
Description
Blood pressure
Timepoint
Just befor injection the anesthetic agents then every 5 minutes during the surgery
Method of measurement
non invasive blood pressure monitoring
3
Description
SPO2
Timepoint
Just befor injection the anesthetic agents then every 5 minutes during the surgery
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Dexemedetomidine (0.5µg/kg) as an IV, bolus dose in 10 minutes slowly and 5 minutes before starting the topical anesthesia. The infusion dose will administer by 0.2 µg/kg/hr for maintenance during the surgery
Category
Diagnosis
2
Description
Control: Remifentanil (0.1µg/kg) as a bolus dose in 10 minutes slowly and 5 minutes before topical anesthesia. The infusion dose will administer 0.05 µg/kg/min for maintenance during the surgery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Mahtab Poor Zamany Nejat Kermany
Street address
9th Boostan, Pasdaran Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor in Research Affairs, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi, phD
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor in Research Affairs, Shahid Beheshti 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
Faculty Member of Shaheed Beheshti University of Medical science
Full name of responsible person
Mahtab Poor Zamany Nejat Kermany
Position
Anesthesiologist
Other areas of specialty/work
Street address
9th Boostan, Pasdaran Ave
City
Tehran
Postal code
1666694516
Phone
+98 21 2360 2175
Fax
+98 21 2254 9029
Email
drmpoorzamani@sbmu.ac.ir, drpoorzamani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty Member of Shaheed Beheshti University of Medical science
Full name of responsible person
Mahtab Poor Zamany Nejat Kermany
Position
Anesthesiologist
Other areas of specialty/work
Street address
9th Boostan, Pasdaran Ave
City
Tehran
Postal code
1666694516
Phone
+98 21 2360 2175
Fax
+98 21 2254 9029
Email
drmpoorzamani@sbmu.ac.ir, drpoorzamani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Member of Shaheed Beheshti University of Medical science
Full name of responsible person
Mahtab Poor Zamany Nejat Kermany
Position
Anesthesiologist
Other areas of specialty/work
Street address
9th Boostan, Pasdaran Ave
City
Tehran
Postal code
1666694516
Phone
+98 21 2360 2175
Fax
+98 21 2254 9029
Email
drmpoorzamani@sbmu.ac.ir, drpoorzamani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)