Protocol summary

Summary
Considering the importance of an appropriate hemodynamic control in patients undergoing spinal fusion surgeries especially heart rate and blood pressure for improvement in surgical field , the necessity of findings drugs with the ability to control the above mentioned parameters has increased. Remifentanil is a short acting and potent opioid which has used in different surgeries for blood pressure and heart rate control. Dexmedtomidine as an alfa-2 agonist has been chosen in this study with this hypothesis that could have a reliable control in blood pressure and heart rate. The study has designed to perform in 50 patients candidated for spinal fusion surgery with ASA class I&II and age between 15-65 years who have signed the informed consent, who had not any heart, lung, kidney and coagulopathy diseases. After block randomization and with randomized number table usage they were grouped to receive either remifentanil infusion as 0.2 micro/Kg/Min or Dexmedtomidine infusion as 1 micro/Kg/hr. Hear rate, blood pressure, oxygen saturation will be measured before and after anesthesia induction, in 1,2 and 3 hours later, after extubation and up to 1 hour in recovery room.Blood loss, surgeon satisfaction from surgical field, anesthesia emergence and extubation time, sedation and pain score in recovery, discharge time and first analgesic requirement time up to 6 hours will also be measured in recovery. The results will be recorded in prepared questionnaire and will be evaluated later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012081410336N3
Registration date: 2012-12-28, 1391/10/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-28, 1391/10/08
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 4036
Email address
p_rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, vice chancellor for research
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of intravenous remifentanil and dexmedtomidine in post spinal fusion surgery
Public title
Comparison remifentanil and dexmedtomidine effects in post spinal fusion surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1-Patients between 15-65 years 2-With American Society of anethesiologist grade I& II 3-Candidated for posterior spinal fusion surgery maximally at 3 levels 4-sign informed consent Exclusion criteria: Having heart, lung, renal and hepatic diseases, coagulopathy No sign the informed consent
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Keshavarz bld-Ghods building
City
Tehran
Postal code
Approval date
2012-04-20, 1391/02/01
Ethics committee reference number
9890

Health conditions studied

1

Description of health condition studied
spinal fusion surgeries
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
blood pressure
Timepoint
each hour
Method of measurement
mmHg-automatic device

Secondary outcomes

1

Description
heart rate
Timepoint
each hour
Method of measurement
beat/min-automatic device

Intervention groups

1

Description
Prescribe two different drugs and monitor their hemodynamic effects 1- first group will receive remifentanil infusion as an anesthesia maintenance with 0.2micro/Kg/min dosage and monitor for hemodynamic changes
Category
Treatment - Drugs

2

Description
Second group will receive dexmedtomidine infusion during surgery as anesthesia maintenance regimen with 1 micro/Kg/hr dosage and will be monitored.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasul Medical Complex
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Chancellor of research/Dr Akbar Fotuhi
Street address
Enghelab St, Poorsina Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university of medical sciences
Full name of responsible person
poupak Rahimzadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Sattarkhan, Niyayesh
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Poupak Rahimzadeh
Position
assistant professor
Other areas of specialty/work
Street address
Sattar khan, Niyayesh
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Assistant prof. of Anesthesiology and pain
Other areas of specialty/work
Street address
Hazrat Rasul medical complex
City
Tehran
Postal code
Phone
00
Fax
Email
p-rahimzadeh@tums.ac.ir
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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