Protocol summary

Summary
The aim of this study is to evaluate the effect of Tizanidin on reducing bleeding during endoscopic sinus surgery that is a double blind study on control and test group.The patients are older than 16 years with ASA class I and II, and nasal polyposis that admitted to the Ghaem hospital and without cardiovascular system pathology, hypertension, liver or kidney disease, hemoglobin below 10 ,have coagulation disorders .Patients were randomly divided into two groups of 25, a control group that recieve placebo and the other group will be recieved 4 mg tizanidine with 50 cc of water, one hour before surgery .After entering patients into the operating room,head up position at 10 degrees,preparation and pre-oxygenation in patients initially for midazolam premedication and Fentanyl injection and then with propofol and Atracuriom induction of anesthesia is given. After 5 minutes the patients will be intubated . During surgery vital signs, including blood pressure measurement, ECG, heart rate, pulse oximetry ,capnography and BIS are controlled.Systolic and diastolic and mean arterial blood pressure with heart rate are recorded after induction, after intubation, after drug administration and every 5 minutes (half an hour) and then every 10 minutes until the end of the surgery. We evaluate surgeon satisfaction and the amount of bleeding based on the criteria of Boezarrt and Likertt . 3 minutes before the end of surgery anesthetic drugs will been reduced, after the complete return of muscle strength and injection reverse , patients will be extubated and transferred to recovery, and after the acquisition criteria of discharge will be transferred to the ward.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022625481N2
Registration date: 2016-10-29, 1395/08/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-29, 1395/08/08
Registrant information
Name
Farzad Hayati
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 51 3609 4575
Email address
fhayati@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of preoperative oral Tizanidine on blood loss in endoscopic sinus surgery
Public title
Effects of Tizanidine on sinus endoscopy bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 16 years undergoing endoscopic sinus surgery • ASA class I and II Exclusion criteria : • high blood pressure (severe) • liver or kidney disease •coagulopathy • Diabetes • Abnormal blood sugar on the morning of the day of surgery • severe hypotension during surgery that requires intravenous administration of large volumes • Lack of consent to participate in the study have. Aspirin or any anticoagulants drugs. hemoglobin under 10.
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
IR.MUMS.sm.REC.1394.206
Secondary trial Id
931463
Registration date
1394-06-11, 777/01/-1377

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qaem Hospital
City
Mashhad
Postal code
Approval date
2015-07-22, 1394/04/31
Ethics committee reference number
IR.MUMS.sm.REC.1394.206

Health conditions studied

1

Description of health condition studied
Nasal polyposis
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Nasal polyp
ICD-10 code
J33.0
ICD-10 code description
Polyp of nasal cavity

Primary outcomes

1

Description
bleeding
Timepoint
after 1 hour
Method of measurement
check list

2

Description
severity of nasal sinus bleeding
Timepoint
before induction, after induction, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80 minutes
Method of measurement
heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure

Secondary outcomes

1

Description
surgeon consent
Timepoint
based on Likert scale
Method of measurement
It will be measured based on a verbal descriptive scale which is related with a visual bleeding score

Intervention groups

1

Description
1 intervention groups: ]n this group of patients recieve Placebo with 50 cc of water, one hour before surgery .During surgery patient's vital signs, including blood pressure measurement, ECG, heart rate, pulse oximetry capnography and BIS will be controlled. Systolic and diastolic and mean arterial blood pressure with heart rate are recorded after induction, after intubation, after drug administration and every 5 minutes (half an hour) and then every 10 minutes until the end of the surgery and case are analyzed.Amount of bleeding and surgeon satisfaction will be evaluated based on Boezarrt and Likertt criteria.
Category
Treatment - Drugs

2

Description
2intervention groups: ]n this group of patients recieve 4mg Tizanidin with 50 cc of water, one hour before surgery .During surgery patient's vital signs, including blood pressure measurement, ECG, heart rate, pulse oximetry Capnography and BIS will be controlled.Systolic and diastolic and mean arterial blood pressure with heart rate are recorded after induction, after intubation, after drug administration and every 5 minutes (half an hour) and then every 10 minutes until the end of the surgery and case are analyzed.Amount of bleeding and surgeon satisfaction will be evaluated based on Boezarrt and Likertt criteria.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Saleheh Asghari
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice chancellor for research Mashhad University of Medical Sciences
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saleheh Asghari
Position
Anesthesia resident
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad abad street, Mashhad
City
Mashhad
Postal code
Phone
+98 915 516 4334
Fax
Email
fhayati@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Jallaiyan Taghadomi
Position
Associate Professor of Mashhad University of Medical Sciences
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad abad street, Mashhad
City
Mashhad
Postal code
00985136094575
Phone
+98 51 3609 4575
Fax
Email
fhayati@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
saleheh asghari
Position
Anesthesia resident
Other areas of specialty/work
Street address
Mashhad, Ahmad abad Boulvard, Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 3609 4575
Fax
Email
fhayati@ut.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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