The aim of this study is to compare effect of duloxetine and clonidine on morphine consumption after total abdominal hysterectomy. Inclusion criteria: are all patient’s candidates for elective trans vaginal hysterectomy and age between 45 to75. Exclusion criteria are history of sensitivity to medication study; patients that received analgesic 8 hours before surgery; history of asthma.; history of hypertension and peripheral neuropathy. .A double blind randomized clinical trail 60 patient divided to two equals group(n=30) All the patients in control group receive preemptive clonidine 0/1 milligrams per kilogram two hours before surgery.. In case group all the patients receive preemptive duloxetine two hours before surgery. Pain score, need to analgesic drugs, patient satisfaction and time of discharge, will be recorded and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507301936N15
Registration date:2015-09-01, 1394/06/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Busheher University of Medical Sciences
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of duloxetine and clonidine on morphine consumption after hysterectomy, A double blind randomized clinical trail
Public title
The comparative effect of duloxetine and clonidine on morphine consumption after hysterectomy. A double blind randomized clinical trail
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:the all patient’s candidates for elective trans vaginal hysterectomy and age between 45 till 75.
Exclusion criteria::history of sensitivity to medication study; patients that received analgesic 8 hours before surgery; history of asthma.; history of hypertension and peripheral neuropathy
Age
From 45 years old to 75 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Bushehr University of Medical Sciences
Street address
Busheher -Siraf Avenue
City
Busheher
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
B-92-15-17
Health conditions studied
1
Description of health condition studied
Effect of dulexitineand and clonidine on morphime consumption in hysterectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post Operative Pain
Timepoint
24 hours
Method of measurement
Visual
Secondary outcomes
1
Description
Patient Satisfication
Timepoint
24 hours
Method of measurement
Question
Intervention groups
1
Description
In control group all patients receive0/1 milligrams per kilogram clonidine
Category
Treatment - Drugs
2
Description
In case group all patients receive 60 milligrams per kilogram dulexitin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr University of Medical Science
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Street address
Bushehr University of Medical Science
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr majid asadi
Street address
Bushehr university of medical science
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associate Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3354 0088
Fax
Email
arna56@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associated Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3354 0088
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr.Abdolreza Najafi Anaraki
Position
Associated Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)