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Comparison of Remifentanil - Propofol versus Fentanyl - Propofol on Urine Output in patients undergoing elective surgery of Posterior Spinal Fixation to General Anesthesia the method Total Intravenous Anesthesia

Protocol summary

Summary
The purpose of this study was to determine the Comparison of Remifentanil - Propofol versus Fentanyl - Propofol on Urine Output in patients undergoing elective surgery of Posterior Spinal Fixation to General Anesthesia. 60 patients in a double-blind clinical trial with random sampling method with Inclusion criteria, including;Elective surgery of Posterior Spinal Fixation; Age range 18-75 years and American Society of Anesthesiologists 1 and 2, and also Exclusion criteria, which include; Lack of patient satisfaction,Under 18 years and more than 75 years, Renal Disease, Uncontrolled Hypertension and Diabetes, Severe Cardiovascular Disease, Hypotension continuously during surgery, Use of medications and drugs affecting renal function both before and during anesthesia, Uncontrollable bleeding during surgery, Anyone who Hospitals affiliated to Tehran University of Medical Sciences in the years 1389-1390 are presented, and selected two groups 30 persons Remifentanil -Propofol and Fentanyl - Propofol we divided .Both groups received the drug in terms of drug Premedication and the Induction are equally. and Remifentanil & Propofol & Atracurium Maintenanse drug in the Target Group and the Control Group included Fentanyl & Propofol & Atracurium.Then demographic characteristics of patients before the anesthesia record. And also Urine Output during anesthesia and the patient's Vital signs every half hour, we recorded and measured.

General information

Acronym
PSF( Posterior Spinal Fixation )
IRCT registration information
IRCT registration number: IRCT201111298083N2
Registration date: 2012-02-11, 1390/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-11, 1390/11/22
Registrant information
Name
Kayvan Latifi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 391 8734
Email address
k-latifi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2010-09-26, 1389/07/04
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Remifentanil - Propofol versus Fentanyl - Propofol on Urine Output in patients undergoing elective surgery of Posterior Spinal Fixation to General Anesthesia the method Total Intravenous Anesthesia
Public title
Remifentanil effect on Urinary Output
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Elective surgery of Posterior Spinal Fixation; Age range 18-75 years; Operation length ≥ 3 hours; ASA 1-2; Normotention. Exclusion criteria: Lack of patient satisfaction;Age < 18 and Age > 75; Operation length < 3 hours; Kidney Disorders; Blood urea and Kratnyn above the normal range of( BUN> 20 and Cr> 1.5 ); ASA > 2; Uncontrolled Hypertension and DM; Severe Cardiovascular Disease; Failure to observe during fasting (8 hours ); Medications of plant installation and material effect on kidney function both before and during anesthesia( eg: Aminoglygozit - Magnesium Sulfate - Radiographic Contrast Agents - some heart medications and blood pressure reduction...); Patients Addicted to Narcotics; Hypotension continuously during Surgery (Systolic Pressure less than 80mmHg); Noncompliance of fluid intake during Anesthesia; Bleeding uncontrolled during Surgery; The use of PEEP in the Anesthesia; emergency surgery; Dehydration before Surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Fakhre Razi st.
City
Tehran
Postal code
Approval date
2010-09-25, 1389/07/03
Ethics committee reference number
42118

Health conditions studied

1

Description of health condition studied
Lumbosacrale Truma
ICD-10 code
M99
ICD-10 code description
Biomechanical lesions, not elsewhere classified

Primary outcomes

1

Description
Urinary Output
Timepoint
Every 30 minutes during Anesthesia
Method of measurement
In terms of cc by Urine Bags

2

Description
Age
Timepoint
Before Anesthesia
Method of measurement
According to Years by ID

3

Description
Sex
Timepoint
Before Anesthesia
Method of measurement
Male or Female

4

Description
Waight
Timepoint
Before Anesthesia
Method of measurement
Kilogram By the Scale

5

Description
ASA
Timepoint
Before Anesthesia
Method of measurement
I & II

6

Description
Past Medical History
Timepoint
Before Anesthesia
Method of measurement
Medical History and Patient Medical Records

7

Description
Drug History
Timepoint
During Anesthesia
Method of measurement
micro/kg/min

8

Description
Blood Pressure
Timepoint
Every 30 minutes during Anesthesia
Method of measurement
In terme of milimetre Hg by Arterial Line

9

Description
Pulse Rate
Timepoint
Every 30 minutes during Anesthesia
Method of measurement
ECG Monitoring

Secondary outcomes

1

Description
Hypotention
Timepoint
During Anesthesia
Method of measurement
mmGh by Arterial Line

2

Description
Beradicardia
Timepoint
During Anesthesia
Method of measurement
Pulse/min by ECG

Intervention groups

1

Description
Intervention group: Remifentanil, 2\0 micro/kg/min , Infusion to the onset of anesthesia , Propofol : 100 micro/ kg / min ,Infusion to the onset of anesthesia
Category
Treatment - Drugs

2

Description
Control group: Fentanil, 5\0 - 5 micro/kg / hr , The bluse during anesthesia , Propofol : 100 micro/ kg / min ,The infusion during anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrateh Rasul Akram Hospital
Full name of responsible person
Dr. Kayvan Latifi
Street address
Hazrateh Rasul Hospital, Niayesh Street, Satarkhan Street
City
Tehran

2

Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Dr.Kayvan Latifi
Street address
Valadi Street , Valiasr Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Chancellor for research of University
Street address
Room 303, First Floor, Official Building (A), School of Medicine
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
Kayvan Latifi
Position
Dr. Anesthesia Asistant
Other areas of specialty/work
Street address
Hazrateh Rasul Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Postal code
Phone
+98 19 2262 6212
Fax
Email
latifikayvan@gmail.comlatifikayvan@yahool.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Valiolla Hassani
Position
Dr./Tehran University Professor and Member of Board of Anesthesiology
Other areas of specialty/work
Street address
Anesthesia Group, Hazrateh Rasul Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
v-hassani@sina.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
Kayvan Latifi
Position
Dr. / Anesthesia Assistant
Other areas of specialty/work
Street address
Anesthesia Group,Hazrateh Rasul Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
latifikayvan@gmail.comlatifikayvan@yahool.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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