Comparing the effect of Ketamin ; Bupivacain and Dexmedetomidine intraperitoneal in controlling the pain after operation in patients are candidates for abdominal hysterectomy
Comparing the effect of Ketamin ; Bupivacain and Dexmedetomidine intraperitoneal in controlling the pain after operation in patients are candidates for abdominal hysterectomy
Design
This study is clinical trial and double blind.105 patients candidates for abdominal hysterectomy in Taleghani Hospital in Arak will inter this study.We will divide patients in 3 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.105 patients candidates for abdominal hysterectomy in Taleghani Hospital in Arak will inter this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients are candidates for abdominal hysterectomy, ASA class 1 and 2, age 30 to 70 years, no sensitivity to drugs
Exclusion criteria:Emergency patients ,dissatisfaction
Intervention groups
The first group will be injected with 0.5 to 0.7 microgram in kilogram dexmedetomidine intraperitoneal , the second group will be injected 20-15 milligram bupivacaine intraperitoneal and the third group will be injected 75-50 milligram ketamin intraperitoneal.
Main outcome variables
Pain, the amount of drug used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N130
Registration date:2020-01-20, 1398/10/30
Registration timing:registered_while_recruiting
Last update:2020-01-20, 1398/10/30
Update count:0
Registration date
2020-01-20, 1398/10/30
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
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Ketamin ; Bupivacain and Dexmedetomidine intraperitoneal in controlling the pain after operation in patients are candidates for abdominal hysterectomy
Public title
comparing the effect ofKetamin; Bupivacain and Dexmedetomidine intraperitoneal in controlling the pain after operation in patients are candidates for abdominal hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are candidates for abdominal hysterectomy
ASA class 1 and 2
Age 30 to 70 years
No sensitivity to drugs
Exclusion criteria:
Emergency patients
Dissatisfaction
Age
From 30 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in three groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B and C are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.ARAKMU.REC.1397.265
Health conditions studied
1
Description of health condition studied
abdominal hysterectomy
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
Pain
Timepoint
Recovery, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Visual analogue of pain
2
Description
Amount of drug used
Timepoint
24 hours after surgery
Method of measurement
Milligram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The first group will be injected with 0.5 to 0.7 microgram in kilogram dexmedetomidine intraperitoneal
Category
Treatment - Drugs
2
Description
Intervention group2: The second group will be injected 20-15 milligram bupivacaine intraperitoneal.
Category
Treatment - Drugs
3
Description
Intervention group3: The third group will be injected 75-50 milligram ketamin intraperitoneal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Taleghani hospital, Emam Khomeini street
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
shokrpour@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street