Protocol summary

Study aim
Effect of oral clonidine premedication on perioperative blood loss in elective primary total hip arthroplasty.
Design
A randomized controlled, double blinded clinical trial with parallel groups, on 34 patients. Randomization is done by the block randomization concealed in sequentially numbered, opaque, sealed envelopes.
Settings and conduct
Trial participants, investigators, healthcare providers for participants and outcome assessors are kept blind. Patients are randomly divided into two groups of 17. 90 minutes before surgery, the intervention group receives 0.2 mg clonidine tablets and the control group a placebo tablet. During operation, mean blood pressure is kept 70-80 mm Hg. The total amount of bleeding is measured by weight of blood gases, blood in suction bottle and around the operative site. Transfusion is done if the bleeding rate exceeds the allowable blood loss or if the patient develops hemodynamic instability and the amount is recorded. After surgery, hemoglobin is measured on the first and third day and transfusion rate is recorded.
Participants/Inclusion and exclusion criteria
ASA class 1 and 2 patients between 18 and 75 years scheduled for unilateral elective primary total hip arthroplasty are enrolled. Patients with ASA class 3 and 4, BMI> 30, hemoglobin<10, severe liver and kidney disease, coagulation disorder, alcoholics, taking anticoagulants, revision total hip arthroplasty or previous surgery in the operated area are excluded.
Intervention groups
Patients in the clonidine group are given 0.2 mg oral clonidine and in the control group, a placebo tablet is given.
Main outcome variables
Intraoperative blood loss, postoperative hemoglobin level, blood transfusion rate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131108015322N5
Registration date: 2021-04-07, 1400/01/18
Registration timing: prospective

Last update: 2021-04-07, 1400/01/18
Update count: 0
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
Shideh Dabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
sdabir@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral clonidine premedication with placebo on perioperative blood loss in total hip arthroplasty surgery patients
Public title
Effect of oral clonidine premedication on blood loss in total hip arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class 1 and 2 patients Elective total hip arthroplasty Primary total hip arthroplasty
Exclusion criteria:
ASA 3 and 4 patients Patients with BMI greater than 30 Patients with Hb less than 10 Patients with severe liver or kidney diseases Patients taking anticoagulants patients with coagulation disorders Alcoholic patients Revision total hip arthroplasty Patients with previous surgery in the operated area
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
To assign patients to two groups, randomization is done by the block randomization method and concealed in sequentially numbered, sealed, opaque envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Then envelopes are glued and placed inside the box, respectively. At the time of the assignment, according to the order of entry of eligible participants into the study, the relevant enveloper is opened in order and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, investigators, healthcare providers for participants and outcome assessors are kept blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi St., Yemen St., Velenjak, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1080

Health conditions studied

1

Description of health condition studied
Intraoperative and postoperative blood loss in total hip arthroplasty
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of bleeding during the operation
Timepoint
After intervention during surgery
Method of measurement
Weighing blood gases, amount of blood in the suction bottle, blood in the operative site

Secondary outcomes

1

Description
Postoperative hemoglobin level
Timepoint
On the first and third day after surgery
Method of measurement
Measured from a blood sample

2

Description
Blood transfusion rate
Timepoint
During surgery and in the postoperative period
Method of measurement
Number of transfused units of blood

Intervention groups

1

Description
Intervention group: Patients receiving clonidine tablet
Category
Treatment - Drugs

2

Description
Control group: Patients receiving placebo tablet
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arabi St., Yemen St., Velenjak, Taleghani Hospital
Full name of responsible person
ُShideh dabir
Street address
Arabi St., Yemen St., Velenjak, Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Dabbagh
Street address
Fourth Floor, Anesthesiology Research Center, taleghani Hospital, Arabi St., Yemen St., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1550
Email
alidabbagh@sbmu.ac.ir
Web page address
https://arc.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh dabir
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
2nd floor, Department of Anesthesiology, Taleghani Hospital, Arabi St., Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh dabir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
2nd floor, Department of Anesthesiology, Taleghani Hospital, Arabi St., Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh Dabir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
2nd floor, Department of Anesthesiology, Taleghani Hospital, Arabi St., Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Fax
Email
shdabir@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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