The purpose of this study will be to assess the effect of oral Tizanidine premedication on blood loss and the quality of the surgical field during endoscopic paranasal sinus surgery
Design
Clinical trial with two arm parallel groups, randomized trial with double blinded assessment. Study phase will be 2-3.
Settings and conduct
In Urmia Imam Khomeini hospital operating room after induction of anesthesia
Amount of bleeding and quality of the surgical field during surgery, mean arterial pressure and postoperative pain will be assessed in recovery and 6 hours after surgery.The anesthesiologist will be unaware which patient will be assigned to which group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 25 to 55 years old؛ American Society of Anesthesiologists class I؛ Chronic sinusitis
Exclusion criteria: Patients in whom controlled decreasing blood pressure is contraindicated; Liver and kidney failure؛ Known sensitivity to tizanidine؛ Systolic blood pressure above 160 and diastolic blood pressure above 90 mmhg؛ Heart rate below 50 in minutes؛ Patients who have received anticoagulant, beta blocker, calcium channel blocker or digoxin
Intervention groups
In the intervention group, patients will receive tizanidine 6 mg and in control group, patients will receive placebo oral, 90 minutes before the operation.
Main outcome variables
Amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027677N12
Registration date:2019-02-22, 1397/12/03
Registration timing:retrospective
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-20, 1395/02/31
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral Tizanidine and placebo on blood loss and the quality of the surgical field during endoscopic paranasal sinus surgery
Public title
The effect of Tizanidine premedication on blood loss and the quality of the surgical field
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 25 to 55 years old
ASA (American Society of Anesthesiologists) class I
Chronic sinusitis
Exclusion criteria:
Patients in whom controlled decreasing blood pressure is contraindicated
Liver and kidney failure
Known sensitivity to tizanidine
Systolic blood pressure above 160 and diastolic blood pressure above 90 mmhg
Heart rate below 50 per minute
Patients who have received anticoagulant, beta blocker, calcium channel blocker or digoxin
Age
From 25 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups of tizanidine 4mg (group T) and placebo (group P) using Random Allocation Software 2.0, and the target codes will be written on a piece of paper and placed in sealed envelopes with sequential allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug will be administered by the nurse in the ward and at the time of admission, the anesthesiologist will be unaware which patient will be assigned to which group. Drug containers will be identical and only the nurse will know about the contents of each of them, and finally, after collecting information by the resident in training in anesthesiology, the anesthesiology specialist will be informed of the group each patient is assigned to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2016-10-26, 1395/08/05
Ethics committee reference number
IR.UMSU.REC.1395.299
Health conditions studied
1
Description of health condition studied
bleeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of bleeding
Timepoint
during surgery
Method of measurement
Measuring the amount of blood inside the suction device and the gases used
2
Description
Quality of the surgical field
Timepoint
During surgery
Method of measurement
Boezaart scale
Secondary outcomes
1
Description
pain
Timepoint
At recovery and 6 hours after surgery
Method of measurement
visual analog scale
2
Description
mean arterial pressure
Timepoint
Every 15 minutes during surgery
Method of measurement
Non invasive pressure gauge
Intervention groups
1
Description
Intervention group: patients will receive tizanidine 6 mg oral tablet, 90 minutes before surgery.
Category
Treatment - Drugs
2
Description
Control group: will receive oral placebo 90 minutes before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room, Khomeini Hospital
Full name of responsible person
Shahryar Sane
Street address
Ershad blvd, Modarres blvd
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 8967
Email
emam-h-urm@umsu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Orjanse alley, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.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