Protocol summary

Study aim
The aim of study is to determine and compare the volume of bleeding and the hemodynamic parameters(Systolic and Diastolic Blood Pressure, Mean Arterial Pressure, Heart rate)during Lumbar Spine Surgery in three groups of Placebo, Tranexamic acid and Clonidine
Design
The clinical trial is randomized, with controlled group, with parallel triple blind groups
Settings and conduct
Participants of elective neurosurgical patients are selected after evaluating entry and exit criteria and are randomly assigned to receive Placebo, Tranexamic acid and Clonidine. Hemodynamic indices are recorded at the basic time(2hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery and the volume of blood loss recorded in the end of the surgery
Participants/Inclusion and exclusion criteria
Age between 20 – 65 year;patients who consent to the informed consent to participate;ASA 1,2;do not use Beta blocker and Calcium blocker;do not use of sedative drugs;do not use of Opioids;do not addiction to Alcohol;not allergic reaction to drug;not allergic reaction to Local anesthetic drugs;not history of lumbar surgery;not risk factor of thrombosis;not use of anticoagulants drugs;not use of Digoxin;not use of Aspirin
Intervention groups
The first group received 600mg oral Tranexamic acid and one placebo tablet, the second group receive 0/2 mg tablet of Clonidine and 2 Capsules of placebo and the third group receive one tablet of Placebo and 2 Capsules of placebo 2 hours before surgery. All of the patients anesthetized with Midazolam, Fentanyl, Propofol, lidocaine and Cysatracurium, for maintenance of anesthesia we used Propofol and for controlled hypotension Remifentanil with goal of MAP between 80-85 mmHg
Main outcome variables
Systolic Blood Pressure;Diastolic Blood Pressure;Mean Arterial Pressure;Heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110528006617N4
Registration date: 2020-07-11, 1399/04/21
Registration timing: retrospective

Last update: 2020-07-11, 1399/04/21
Update count: 0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Mehrdad Masoudifar
Name of organization / entity
Esfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1268 2007
Email address
masoudifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral Clonidine and Tranexamic acid before Surgery on blood loss in lumbar spine surgery
Public title
The effect of oral Clonidine and Tranexamic on blood loss during surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 – 65 year patients who consent to the informed consent to participate in the study ASA class 1 ,2
Exclusion criteria:
Beta blocker and Calcium blocker usage sedative drugs usage Opioids usage addiction to Alcohol allergic reaction to drugs allergic reaction to Local anesthetic drugs history of lumbar surgery risk factor of thrombosis anticoagulants drugs usage Digoxin usage Aspirin uage
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
First with attention to the number of groups(3 groups)and the number of persons in every group, explained an amount of six block. So all of the situations that six person can stay on that block and stay on the study in form of couple in one of the triple group. After that randomized selection of the block with table of accidental numbers in fifteen times between all of the form in arrangement have done and fifteen blocks an amount of six selected, that allocated to every group two persons.
Blinding (investigator's opinion)
Triple blinded
Blinding description
We produced Placebo Capsule similar to Tranexamic Acid and Placebo tablets similar to Clonidine. The Tranexamic Acid group received 2 Capsules of Tranexamic Acid and one tablet of Placebo 2 hours before surgery, the Clonidine group received 2 Capsules of Placebo and one tablett of Clonidine 2 hours before surgery, the Placebo group received 2 Capsules of Placebo and one tablett of Placebo 2 hours before surgery. So the patients do not have any information about the intervention and the person who registered the information do not know which patient in which group ist and the study has three blind side.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical sciences
Street address
Isfahan University Of Medical Science, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-06-22, 1399/04/02
Ethics committee reference number
IR.MUI.MED.REC.1399.244

Health conditions studied

1

Description of health condition studied
General anesthesia
ICD-10 code
M51.06
ICD-10 code description
Intervertebral disc disorders with myelopathy, lumbar region

Primary outcomes

1

Description
Systolic Blood Pressure
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
mmHg , SAADAT Sphygmomanometer monitoring

2

Description
Diastolic Blood Pressure
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
mmHg , SAADAT Sphygmomanometer monitoring

3

Description
Mean Artherial Pressure
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
mmHg , SAADAT Sphygmomanometer monitoring

4

Description
Heart rate
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
beat/min , SAADAT ECG monitoring

5

Description
Volume Of Blood Loss
Timepoint
enter to the recovery, export from recovery
Method of measurement
Milliliter,volume of blood in the suction, Bloody gas

6

Description
Surgeon Satisfaction
Timepoint
End of the surgery
Method of measurement
Likert Scale

Secondary outcomes

1

Description
Hypotension
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
mmHg, SAADAT Sphygmomanometer monitor

2

Description
Hypertension
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
mmHg, SAADAT Sphygmomanometer monitor

3

Description
Tachycardia
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
beat/min ,SAADAT ECG monitoring

4

Description
Bradycardia
Timepoint
Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery
Method of measurement
beat/min ,SAADAT ECG monitoring

Intervention groups

1

Description
Intervention group: The first intervention group(Tranexamic acid) receive 600mg oral Tranexamic acid and one placebo tablet 2 hour before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg)
Category
Treatment - Drugs

2

Description
Intervention group: The second intervention group(Clonidine) receive 0/2 mg tablet of Clonidine and 2 Capsules of placebo 2 hours before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg)
Category
Treatment - Drugs

3

Description
Control group: The second intervention group(Placebo) receive one tablet of Placebo and 2 Capsules of placebo 2 hours before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mehrdad Masoudifar
Street address
Alzahra hospital, Sofe Blvd, Shahid Keshvari Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Science,Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 8663 8318
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra Hospital, Sofe Blvd, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Masoudifar@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Sofe Blvd, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098 31 362020202
Email
Masoudifar@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 913 316 2343
Email
masoudifar@mui.ac.ir

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
Undecided - It is not yet known if there will be 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
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
Undecided - It is not yet known if there will be a plan to make this available
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