Determining the effect of oral clonidine on reducing bleeding during hysterectomy surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Random Allocation software was used for randomization.
Settings and conduct
In the present double-blind clinical trial study, 70 patients who are candidates for elective abdominal hysterectomy in Hajar Hospital in Shahrekord are included in the study. Resident during operation and gas counting and statistical consultant is unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. age 60-40 years
۲. Patient informed consent
3. No pregnancy and use of birth control pills
4. Absence of systemic diseases and inherited or acquired coagulation disorders
5. No history of ischemic heart disease
6. No history of taking anticoagulants that affect bleeding
7. No smoking and alcohol
8. Known insensitivity to clonidine
9. No history of repeated abdominal surgeries and the presence of abdominal adhesions
Exclusion criteria:
1. Need for reoperation
2. The patient withdraws from the study or does not cooperate for further follow-up.
3. Raynaud's syndrome, porphyria, renal dysfunction
Intervention groups
Intervention group: Clonidine tablets 0.2 (mg) 90 minutes before surgery
Control group: placebo tablets 90 minutes before surgery
Main outcome variables
The amount of bleeding during the operation; Hemoglobin and hematocrit before and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211117053086N1
Registration date:2022-01-18, 1400/10/28
Registration timing:registered_while_recruiting
Last update:2022-01-18, 1400/10/28
Update count:0
Registration date
2022-01-18, 1400/10/28
Registrant information
Name
Bibi Fatemeh Alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 8575
Email address
eslami@ualberta.ca
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral Clonidine on reducing bleeding during hysterectomy
Public title
Evaluation of the effect of oral Clonidine on reducing bleeding during hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient informed consent
No pregnancy and use of birth control pills
Absence of systemic diseases and inherited or acquired coagulation disorders
No history of ischemic heart disease
No history of taking anticoagulants that affect bleeding
No smoking and alcohol
Known insensitivity to clonidine
No history of repeated abdominal surgeries and the presence of abdominal adhesions
Exclusion criteria:
Raynaud's syndrome
porphyria
Renal dysfunction
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were selected by convenience sampling method and Random Allocation divided into two groups A and B using clonidine (0.2 mg) and placebo tablets, respectively using randomizer software (Fahmy Corporation, Randomizer 2016.6.0.56).
Blinding (investigator's opinion)
Double blinded
Blinding description
Resident (during operation and gas counting) and statistical consultant are unaware of the type of grouping (intervention or control)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Building No. 2, University Headquarters,Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SKUMS.REC.1400.178
Health conditions studied
1
Description of health condition studied
hysterectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding rate
Timepoint
Immediately after surgery
Method of measurement
Visual estimation scale: The number of normal gases impregnated in blood is multiplied by 10 ml and long gases by 50 ml and the result is added to the volume of suctioned blood. Since this volume is included in the volume of rinsing fluids in the surgical area; It also reduces the amount of fluid consumed and the result is equal to the amount of actual blood loss of the patient.
Secondary outcomes
empty
Intervention groups
1
Description
The first group will be prescribed routine surgical preparations and clonidine tablets 0.2 (mg) 90 minutes before entering the operating room. This medicine will be provided by a Tolid-Daroo company.
Category
Prevention
2
Description
Control group: In the second group, routine procedures will be performed to prepare for surgery, and a placebo will be provided by Tolid-Daroo company. Placebo tablets will be given 90 minutes before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Lobat Jafarzadeh
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
jafarzade@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Vice Chancellor for Research, Building No. 2, University Headquarters, Ayatollah KashaniBlvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
Sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Alavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
eslami@ualberta.ca
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Alavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
eslami@ualberta.ca
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Alavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
eslami@ualberta.ca
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information is kept confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Shahrekord University of Medical Sciences, Dr. Lobat Jafarzadeh
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his researchand the reason for using the data can be provided