A Comparison between neostigmin and ketamin as adjvant with bupivacain 0.25% in epidural method for post oparative pain control in patient with femoral fracture and candidate for elective surgery
The purpose of this study is to compare the effects of neostigmine and ketamine added to bupivacaine 25/0% in the epidural analgesia after surgery in patients with femoral fractures are candidates for non-emergency surgery. This study is a double blind Randomized clinical trial that perform on patient candidated for elective femoral surgury with mentioned above criteria. In this study, all patients over age 50 are candidates for elective surgery and the ASA are rated Class 1 and 2. All of them randomizedly divided in three groups. A( neostigmine), B(ketamin), C(placebo). Pain score check for all patient in recovery and 6,12 and 24 hours after sergury. During sergury BP,PR, HR, O2Sat and ECG record evrey 5 minutes. Evrey group containe 30 patient. All data analize with statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112198468N1
Registration date:2012-04-25, 1391/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-25, 1391/02/06
Registrant information
Name
Abbas Zareei
Name of organization / entity
Arak medicl university
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 6055
Email address
dr.zarei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University Of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison between neostigmin and ketamin as adjvant with bupivacain 0.25% in epidural method for post oparative pain control in patient with femoral fracture and candidate for elective surgery
Public title
A Comparison between neostigmin and ketamin as adjvant with bupivacain 0.25% in epidural method for post oparative pain control in patient with femoral fracture and candidate for elective surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Age above 50 y/o, ASA class 1 and 2, Elective sergury candidate, No sensitivity to local anesthetic, No contrandication to rgional anesthesia, Exclusion criteria:
Sergury above 2hours, Failuer of epidural anesthesia, Concomitant fracture, Fever and infection
Age
From 50 years old to 100 years old
Gender
Both
Phase
N/A
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
Arak University Of Medical Science
Street address
Basij Square
City
Arak
Postal code
3819693345
Approval date
2011-07-04, 1390/04/13
Ethics committee reference number
2-109-90
Health conditions studied
1
Description of health condition studied
Femor Fracture Sergery
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Pain Scre
Timepoint
During serger, in recovery,6and 12 and 24 hours after sergery
Method of measurement
Visual Analog Sore
Secondary outcomes
1
Description
Vital Sign: BP,HR PR O2Sat,ECG
Timepoint
During serger,in recovery,6and 12 and 24 hours after sergery
Method of measurement
Electronic Monitoring Device
Intervention groups
1
Description
group A; neostigmine 60 mcg added to 2cc/segment of 0.25% bopivacaine in atotal volume 20cc with water for injectin
Category
Treatment - Drugs
2
Description
group B; KETAMIN 40 mg added to 2cc/segment of 0.25% bopivacaine in atotal volume 20cc with water for injectin
Category
Treatment - Drugs
3
Description
group C; only 2cc/segment of 0.25% bopivacaine in atotal volume 20cc with water for injectin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
DrAbbas Zareei
Street address
Valiasr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr saed Changizi Ashtiyani
Street address
A'lam,Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, 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
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 Univesity Of Medical Sciences
Full name of responsible person
Dr Abbas Zareei
Position
MD/ Resident Of Anesthesiology
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
3819693345
Phone
+98 86 1223 1103
Fax
+98 86 1222 2003
Email
dr.zarei@arakmu.ac.ir
Web page address
www.portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Esmaeil Moshiri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
00988612231283
Phone
+98 86 1223 1103
Fax
+98 86 1222 2003
Email
Moshiri_e@yahoo.com
Web page address
www.portal.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Abbas Zareei
Position
MD/ Resident Of Anesthesiology
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
3819693345
Phone
+98 86 1223 1103
Fax
+98 86 1223 1283
Email
dr.zarei@arakmu.ac.ir
Web page address
www.portal.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)