Dexmedetomidine versus remifentanil in post operative pain control after spine surgery.
Design
Clinical trial with double- blinded postoperative care and outcome assessment.Randomisation will be carried out using random digits table.
Settings and conduct
This double-blinded clinical trial will be done in Ahwas Golestan hospital. In this study patients and anesthesiologist will be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-65 ;elective spine surgery;ASA class 1and 2.
Exclusion criteria: previous spine surgery; opium addiction;alcohol addiction; neurological, neuromuscular, psycological, pulmonary and cardiovascular diseases; prolonged usage of analgesic (cox-2 inhibitors); intra operative unpredictable events such as massive bleeding.
Intervention groups
Intervention group 1:Dexmedetomidine group(Dexmedetomidine single-dose before general anesthesia and dexmedetomidine infusion durig operation),Intervention group 2:Remifentanil group(Remifentanil single_dose before general anesthesia and remifentanil infusion during operation)
In this study spinal surgery patients will be devided to two groups recieving dexmedetomidine and remifentanile in random using random digits table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist who has responsible for the patients management of anesthesia will administer the medicine (s) via coded syringes had been prepared previously and will not aware of the injected drug (dexmedetomidin or remifentanile), and anesthesia nurse who is responsible for collection of patients information and study variables is unaware of the administered drug will record the check- list during surgery and in the recovery. Also the patient is unaware of the injected medicine.
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 Sciences
Street address
Golestan hospital; Golestan avenue
City
Ahwaz
Province
Khouzestan
Postal code
6136763316
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.AJUMS.REC.1398.593
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
30, 60 and 120 minutes and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Systolic blood pressure variance
Timepoint
30, 60 and 120 minutes and 24 hours after surgery
Method of measurement
blood pressue monitor
2
Description
Diastolic blood pressue variance
Timepoint
30, 60 and 120 minutes and 24 hours after surgery
Method of measurement
blood pressure monitoring
3
Description
Heart rate variance
Timepoint
30, 60 and 120 minutes and 24 hours after surgery
Method of measurement
heart rate monitoring
4
Description
O2 saturation variance
Timepoint
30, 60 and 120 minutes and 24 hours after surgery
Method of measurement
Pulseoxymetry
Intervention groups
1
Description
Intervention group1:serum ringer lactate 5 ml/kg,midazolam 0.02 mg/kg,fentanyl 2mcg/kg,propofol1.5 mg/kg,atracuriom 0.5 mg/kg,morphine sulfate 0.1 mg/kg for induction and dexmedetomidine0.1mcg/kg in 10 minutes(Abureyhan _Iran co.) and for maintnance propofol 100 to 150 mcg/kg besides dexmedetomidine0.1mcg/kg/h will recieve.
Category
Diagnosis
2
Description
Intervention group2:serum ringer lactate 5 ml/kg,midazolam 0.02 mg/kg,fentanyl 2mcg/kg,propofol1.5 mg/kg,atracuriom 0.5 mg/kg,morphine sulfate 0.1 mg/kg for induction and remifentanile bollus dose(Abureyhan _Iran co.) 1 mcg/kg and for maintnance propofol 100 to 150 mcg/kg besides 1 mcg/kg/min remifentanile will recieve.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Golestan hospital
Full name of responsible person
Mohammad Zafari
Street address
Golestan avenue
City
Ahwaz
Province
Khouzestan
Postal code
6136763316
Phone
+98 61 3374 3348
Email
mohammad.zafari2@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farahzad Jannatmakan
Street address
Golestan avenue
City
Ahwaz
Province
Khouzestan
Postal code
6136763376
Phone
+98 61 3376 8483
Email
mohammad.zafari2@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
Farahzad Janatmakan
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan avenue
City
Ahwaz
Province
Khouzestan
Postal code
6136766337
Phone
+98 61 3374 8388
Email
janatmakan-f@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nozar Nassajian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan avenue
City
Ahwaz
Province
Khouzestan
Postal code
6136768831
Phone
+98 61 3376 6841
Email
nasajian-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Jarir Ahmadi
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan avenue
City
Ahwaz
Province
Khouzestan
Postal code
61377641112
Phone
0098 61 3374551441
Email
jarirahmadi-s@ajums.ac.ir
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
data after the end of study will be avalable.
When the data will become available and for how long
from 2021
To whom data/document is available
physicians
Under which criteria data/document could be used
using for future studies.
From where data/document is obtainable
send E-Mail to Mohammad.zafari2@yahoo.com
What processes are involved for a request to access data/document