Protocol summary

Summary
Aim of this study is comparative intrathecal dexmedetomidine and sufentanyl as adjutants to ‎Bupivacaine in Dynamic hip screw operations. This study is clinical trials and double blind. We will enter ‎‎80 patients with Dynamic hip screw operations in Valiasr hospital. We will divide patients in two groups ‎randomly (each group 40 patients).We will inject 8 milligram Bupivacaine and 5 microgram ‎dexmedetomidine in first group and We will inject 8 milligram Bupivacaine and 2.5 microgram ‎sufentanyl in second group. We will check motor blocks every 20 minute. Researcher will check pain in ‎‎1 and 2 and 6 and 12 and 24 hours after surgery.The amount of Apotel needed in 24 hours ‎after surgery, will be measured. Inclusion criteria: 20 to 60 years; Dynamic hip screw operations Exclusion criteria: allergy to dexmedetomidine and Bupivacaine ;breastfeeding women; hepatic and ‎renal and cardiovascular disease; history of addiction; diabetes; long-term use of analgesics; taking ‎Psychiatric Drug; anticoagulant; deformity of the spine; coagulation disorders; skin infection in site of ‎spinal block

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050220258N45
Registration date: 2017-08-04, 1396/05/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-04, 1396/05/13
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research,Arak University of Medical Sciences
Expected recruitment start date
2016-04-25, 1395/02/06
Expected recruitment end date
2018-04-26, 1397/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of intrathecal dexmedetomidine and su fentanyl as adjuvants to Bupivacaine in Dynamic hip screw operations
Public title
Effect of dexmedetomidine and su fentanyl as adjuvants to Bupivacaine in Dynamic hip screw operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20 to 60 years; Dynamic hip screw operations Exclusion criteria: allergy to dexmedetomidine and Bupivacaine ;breastfeeding women; hepatic and renal and cardiovascular disease; history of addiction; diabetes; long-term use of analgesics; taking Psychiatric Drug; anticoagulant; deformity of the spine; coagulation disorders; skin infection in site of spinal block
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomize with random numbers table blinding: patients and analyzer and person that complete questionnaire were unaware of group assignment

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.ARAKMU.REC.1395.32

Health conditions studied

1

Description of health condition studied
fracture of hip
ICD-10 code
S72.0
ICD-10 code description
Fracture of neck of femur

Primary outcomes

1

Description
motor block
Timepoint
every 20 minute
Method of measurement
bromeg scale

2

Description
pain
Timepoint
1 and 2 and 6 and 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale

3

Description
use Apotel
Timepoint
in 24 hours after surgery
Method of measurement
milligram

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:We will inject 8 milligram Bupivacaine and 5 micro gram dexmedetomidine in first group ‎.
Category
Treatment - Drugs

2

Description
Intervention group:We will inject 8 milligram Bupivacaine and 2.5 micro gram sufentanyl in second group.‎
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Bijan Yazdi
Street address
Valiasr hospital, Valiasr squre
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamodin Modir
Position
Faculty member, anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
modir@arakmu.a.c.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Bijan Yazdi
Position
Faculty, Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
yazdi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanie Masori
Position
medicine student
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86332222003
Fax
+98 863222003
Email
h.masoori@gmail.com
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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