The aim of this study is to determine the effect of adding Midazolam to Bupivacaine in spinal anesthesia.In this tripl blind clinical trial, 80 patients who undergo lower limb orthopedic surgery with spinal anesthesia are randomly divided into two groups of 40 person and equally are placed under spinal anesthesia with Bupivacaine.The first group 3ml Bupivacaine % 0.5 with 0.4 ml saline and the second group 3ml Bupivacaine % 0.5 with 0.4 ml Midazolam (2mg) will receive. In both groups the onset of sensory - motor block, the level of anesthesia, duration of anesthesia and adverse effects will be evaluated.Patient information will be compiled in check list and analyzed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021716612N1
Registration date:2014-06-06, 1393/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-06, 1393/03/16
Registrant information
Name
Khatereh Isazadehfar
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1225 1693
Email address
kh.isazadehfar@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Science
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-20, 1393/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of adding intrathecal midazolam to bupivacaine in spinal anesthesia for pain reduction in lower limb orthopedic surgery
Public title
The effects of adding intrathecal midazolam to bupivacaine in spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for lower limb orthopedic surgery, aged 15 to 80 years
Exclusion criteria: Patients with impaired consciousness, lack of patient cooperation
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical sciences
Street address
Ardabil University of Medical sciences, Ardabil, Iran
City
Ardabil
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
arums.rec.92.11
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
Y83.8
ICD-10 code description
Other surgical procedures
Primary outcomes
1
Description
pain
Timepoint
per hour upto 6 hour after operation
Method of measurement
visual analoug scale
Secondary outcomes
1
Description
postoperative sedation
Timepoint
6 hour after surgery
Method of measurement
Ramsy scale
Intervention groups
1
Description
for control group3 ml bupivacain 0.5 % with 0.4 ml saline
Category
Prevention
2
Description
for intervention group 3 ml bupivacain 0.5% with 0.4 ml midazolam (2 mg)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Masood Entezariasl
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Akbar Pirzadeh
Street address
School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Khatereh Isazadehfar
Position
Assistant professor of Community Medicine
Other areas of specialty/work
Street address
Emam Khomeiny Hospital, Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1223 6680
Fax
Email
isazadehfar@yahoo.com kh.isazadehfar@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Masood Entezariasl
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Fatemy Hospital, Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1225 1688
Fax
Email
m.entezari@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. khatereh Isazadehfar
Position
Assistant professor of Community Medicine
Other areas of specialty/work
Street address
Emam Khomeiny Hospital, Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1225 1693
Fax
Email
isazadehfar@yahoo.com kh.isazadehfar@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)