A comparative study about the effect of Dexmedetomidine with Fentanyl on Post Operative Analgesia in Patient with Femur Fracture under Epidural Anesthesia
A comparative study effect of dexmedetomidine with fentanyl on postoperative analgesia in the femur fracture under epidural anaesthesia
Design
Two arm parallel-group randomised trial with double-blinded postoperative care and outcome assessment.
Settings and conduct
The study is performed in Ahvaz EmamKhomeni Hospital. All patient after monitoring and necessary measures epidural anaesthesia performed with one of the studied drugs. Double-blind study
Participants/Inclusion and exclusion criteria
Admission requirements are patient with ASA class 1and2. Age between 20and 80 years؛ Exclusion criteria are cardiovascular patients. Coagulation disorder.Spinal deformity.Infection of the site.Obesity. Allergy to the drugs. Addiction.
Intervention groups
First intervention group 23patient under epidural anaesthesia with Fentanyl. Second intervention group23patient under epidural anaesthesia with Dexmedetomidine.
Main outcome variables
Postoperative pain؛ Effect start time؛ Duration of effect؛ Repeat dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200613047760N1
Registration date:2020-08-26, 1399/06/05
Registration timing:registered_while_recruiting
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Seyedeh fatemeh Hosseininejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 5099
Email address
hosseininejad.f@mail.ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-19, 1399/03/30
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study about the effect of Dexmedetomidine with Fentanyl on Post Operative Analgesia in Patient with Femur Fracture under Epidural Anesthesia
Public title
Comparision of Dexmedetomidine and Fentanyl in pain control.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with ASA class 1,2
Age between 20 to 80
Exclusion criteria:
Cardiac disease patient
Hematologic disease
Skelletal deformity
Infection of epidural site
Obesity with BMI over 30
History of allergy to drugs that use
Addiction
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patient according to Randomise Block Perotation divided into two groups.For example for fourth block، 6block ABBA, AABB, ABAB,BABA, BBAA, BAAB exist . We placed sampling in n/4 of these blocks.Then .we use of www.sealedenevelope.com for Block Randomise
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Science
Street address
Medical College, Jondishapoor University, Ahwaz,khuzestan
City
Ahwaz
Province
Khouzestan
Postal code
6173946831
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.AJUMS.REC.1398.987
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative analgesia with Visual analogue scale score(vas score)
Timepoint
1,2,4,6,12,24 houre after operation
Method of measurement
Visual analogue scale score (vas score)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 150 miligram of rupivacaein 0.5 % Astrazeneca france company with 1 mg / kg dexmedetomidine exire iran company to 31 cc and injection to epidural space
Category
Treatment - Drugs
2
Description
Intervention group: 150 mg rupivacaein 0.5% Astrazeneca france company with 1 mg/ kg fentanyl abureihan iran company to 31 cc and injection to epidural space
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Emam Khomeini Hospital
Full name of responsible person
Seyedeh Fatemeh Hosseininejad
Street address
Emam khomeini Hospital , 24 Metri, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6173946831
Phone
+98 61 3443 5099
Email
drhosseininejad @yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hosseininejad
Street address
Ahvaz, 24 Metri Ave, Emam Khomeini Hospital, Anesthesiology Center
City
Ahvaz
Province
Khouzestan
Postal code
6173946146
Phone
+98 61 3443 5099
Email
drhosseininejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hosseininejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam khomeini Hospital, 24Metri Ave, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6173946831
Phone
+98 61 3443 5099
Email
drhosseininejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hosseininejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam khomeini, 24 Metri Ave, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6173946146
Phone
009834435099
Email
drhosseininejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hosseininejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam khomeini Hospital, 24 Metri Ave, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6173946146
Phone
+98 61 3443 5099
Email
drhosseininejad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data related to project bublished in the end of project with out say the name of patient
When the data will become available and for how long
In the end of project
To whom data/document is available
Researchers in science unit
Under which criteria data/document could be used
Select better drug in practice
From where data/document is obtainable
dr seyedeh fatemeh hosseininejad
drhosseininejad@yahoo.com
What processes are involved for a request to access data/document