A clinical trial to comparison the effectiveness of oral Tizanidine and placebo on duration of sensory block and hemodynamic changes in patients undergoing limb orthopedic surgery under spinal anesthesia
Objective: To compare the effectiveness of oral Tizanidine and placebo on duration of sensory block and hemodynamic changes in patients undergoing limb orthopedic surgery under spinal anesthesia.
Design: A single-blinded, block randomized clinical trial.
Study population: Patients are undergoing limb orthopedic surgery under spinal anesthesia.
Inclusion criteria: Aged between 18 and 60 years; ASA I or II scheduled for limb orthopedic surgery under spinal anesthesia.
Exclusion criteria: History of high blood pressure; history of uncontrolled diabetes; history of cardiovascular disease; history of renal failure; history of cirrhosis; history of smoking or drug abuse; patients with paresthesia higher levels of T4.
Sample size: 70 cases.
Study intervention: The control group are revising 4 mg of placebo 90 minutes before spinal anesthesia, intervention group are revising 4 mg of oral Tizanidine 90 minutes before spinal anesthesia.
Study outcome: Duration of sensory block is measuring each 15 minutes after spinal anesthesia by pin prick method. Blood pressure and heart rate are measuring before and 5, 10, 15, 30, 60 and 90 minutes after spinal anesthesia by monitoring.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610104780N10
Registration date:2016-10-21, 1395/07/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-21, 1395/07/30
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparison the effectiveness of oral Tizanidine and placebo on duration of sensory block and hemodynamic changes in patients undergoing limb orthopedic surgery under spinal anesthesia
Public title
The effectiveness of oral Tizanidine on duration of sensory block in patients undergoing surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18 and 60 years; ASA I or II scheduled for limb orthopedic surgery under spinal anesthesia.
Exclusion criteria: History of high blood pressure; history of uncontrolled diabetes; history of cardiovascular disease; history of renal failure; history of cirrhosis; history of smoking or drug abuse; patients with paresthesia level higher than T4.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done using block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2011-12-08, 1390/09/17
Ethics committee reference number
IR.MUMS.REC.1390.12
Health conditions studied
1
Description of health condition studied
Orthopedic surgery under spinal anesthesia
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Duration of sensory block
Timepoint
Each 15 minutes after spinal anesthesia
Method of measurement
Pin prick method
Secondary outcomes
1
Description
Blood pressure and heart rate
Timepoint
Before and 5, 10, 15, 30, 60 and 90 minutes after spinal anesthesia
Method of measurement
Monitoring
Intervention groups
1
Description
Control group: they will recieve 4 mg of placebo, 90 minutes before spinal anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group: they will recieve 4 mg of oral Tizanidine 90 minutes before spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mohammad Alipour
Street address
Ghaem Hospital, Ahmadabad Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
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, 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
Mohammad Alipour
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
alipourm@mums.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
Mohammad Alipour
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
alipourm@mums.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
Mohammad Alipour
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
alipourm@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)