The purpose of this study was to evalute the efficacy of oral tizanidine in preventing pain and meperidine consumption during perianal surgery under spinal anesthesia.60 male patients schedule for anorectal surgery under spinal anesthesia were enrolled in this study.patients were randomized into two groups of case and control.case group recieaved 4mg tizanidine and control group recieaved placebo 1 hour before surgery.VAS and meperidine consumption and side effects were recorded during the anesthesia and for 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210315381N3
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research Babol University Of Medical Science
Expected recruitment start date
2012-07-31, 1391/05/10
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral tizanidine for postoperative pain in perianal surgery.
Public title
Efficacy of oral tizanidine for postoperative pain in perianal surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria :patients of candidate of perianal surgery; males; ASA I-II; elective surgery; 20-55 years
exclusion criteria:,psychology disorder; addiction; history of allergy; history of hypertension; drug history of clonidine and tizanidine; surgery duration longer than 2 hours.
Age
From 20 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University Of Medical Sciences
Street address
Daneshgah Sq - Ganjafrooz Av
City
Babol
Postal code
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
6830/30/ژ/پ
Health conditions studied
1
Description of health condition studied
preanal surgery
ICD-10 code
k62.9
ICD-10 code description
disease of anus and rectum,unspecified
Primary outcomes
1
Description
Pain severity
Timepoint
From the first hour after surgery for 24 hours, every 8 hour
Method of measurement
visul analoge scale
2
Description
meperidine consumption
Timepoint
24 hours
Method of measurement
meperidine consumption(mg)
Secondary outcomes
1
Description
Patient's hemodynamics
Timepoint
24 hours after surgery
Method of measurement
Blood pressure and heart rate were evaluated by digital monitoring devices.
2
Description
nausea, vomiting
Timepoint
24 hours
Method of measurement
Through a questionnaire and observation
Intervention groups
1
Description
intervention:tizanidine,4 mg,one hour before surgery.
Category
Treatment - Drugs
2
Description
control:plasebo,one hour before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Behshti Hospital
Full name of responsible person
Dr Mohammad Ali Roupani
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol 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
Babol University Of Medical Sciences
Full name of responsible person
dr nadia banihashem
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
babol
Postal code
Phone
+98 11 1223 8296
Fax
+98 11 1223 8296
Email
nbanihashem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Roupani
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
roupanima@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
dr nadia banihashem
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
babol
Postal code
Phone
+98 11 1223 8296
Fax
+98 11 1223 8296
Email
nbanihashem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)