Comparison effect of topical Dexmedetomidine infiltration with subcutaneous Ketamine on postoperative pain in patients candidating abdominal hysterectomy under general anesthesia
Aim of this study is comparison effect of topical Dexmedetomidine infiltration subcutaneous Ketamine on postoperative pain in patient’s candidate abdominal hysterectomy under general anesthesia. This study is clinical trial. We divide 126 patients in 3 groups randomly (each group 42 person).Inclusion criteria: abdominal hysterectomy; general anesthesia; 30-65 years; duration of surgery maximum 120 minute; ASA I and II .Exclusion criteria: allergy for Dexmedetomidine and Ketamine; duration of surgery more than 120 minute; cardiovascular and pulmonary disease. We inject 50 micro gram Dexmedetomodine subcutaneous in first group and we inject 100 milligram Ketamine subcutaneous in second group .We inject 5 milliliter normal saline subcutaneous in third group. We record mean duration of analgesia and score of pain by Visual Analog scale in 2, 4 and 8 hours after surgery. We record amount of narcotic drug and first request narcotic drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122520258N20
Registration date:2017-02-21, 1395/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-21, 1395/12/03
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
Vice Chancellor for Research Arak University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of topical Dexmedetomidine infiltration with subcutaneous Ketamine on postoperative pain in patients candidating abdominal hysterectomy under general anesthesia
Public title
Comparison effect of Topical Dexmedetomidine Infiltration with Subcutaneous Ketamine on postoperative Pain in surgery general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: abdominal hysterectomy; general anesthesia; 30-65 years; duration of surgery maximum 120 minute; ASA I and II
Exclusion criteria: allergy for Dexmedetomidine and Ketamine; duration of surgery more than 120 minute; cardiovascular and pulmonary disease
Age
From 30 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Postal code
38149578558
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
IR.ARAKMU.REC.1395.297
Health conditions studied
1
Description of health condition studied
Abdominal hysterectomy
ICD-10 code
99.3 N
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
Mean duration of analgesia
Timepoint
2,4 and 8 hours after surgery
Method of measurement
Minute
2
Description
Score of pain
Timepoint
2,4 and 8 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire
3
Description
Amount of Narcotic drug
Timepoint
End of study
Method of measurement
miligeram
4
Description
Request narcotic drug
Timepoint
First time for request narcotic
Method of measurement
Minute after surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 50 microgram Dexmedetomodine subcutaneous.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 100 milligram Ketamine subcutaneous.
Category
Treatment - Drugs
3
Description
Control group: We inject 5 milliliter normal saline subcutaneous.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Emam Khomeini street, Taleghani hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences