Protocol summary

Summary
Operations that may occur in the upper part of the femur in elderly becuase hip fracture or femoral neck fracture , total hip replacement. For surgery of the upper femur used tow ways : regional or general anesthesia . This study is a prospective randomized clinical trial single blind in Tabriz Shohada Medical Center and will be done in1392 . The number of samples in each group and 30. The following routine monitors were applied: electrocardiogram, noninvasive blood pressure cuff, radial arterial line, pulse oximetry, end-tidal CO2, will be performed for patients with CVL was inserted during surgery and was kept at 10-12 kg / 7 ml tidal volume to be infused after anesthetic induction and maintenance of anesthesia, propofol was used in the second group was used for maintenance of anesthesia low dose of isoflurane gas

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309297313N2
Registration date: 2014-01-09, 1392/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-09, 1392/10/19
Registrant information
Name
Mirmohammadtaghi Mortazavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3669 1953
Email address
mortazavimt@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Universityof Medical Sciences
Expected recruitment start date
2013-09-29, 1392/07/07
Expected recruitment end date
2013-12-28, 1392/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison hemodynamic change with low dose isoflurane anesthesia and propofol in intravenous anesthesia for upper femoral surgery in old persons
Public title
Comparison hemodynamic change with low dose isoflurane anesthesia and propofol in intravenous anesthesia for upper femoral surgery in old persons
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : patients with ASA physical status I and II؛ aged over 55 yr ؛ for upper femoral surgery Exclusion criteria : MI؛ CHF ؛ COPD؛ Coagulation disorder؛ Renal diorder؛ Sever dehydratation؛ sever Bleeding in Opration
Age
From 55 years old to 90 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz univercity of medical sciences
Street address
Golgasht Ave Tabriz Iran
City
Tabriz
Postal code
Approval date
2013-06-23, 1392/04/02
Ethics committee reference number
9264

Health conditions studied

1

Description of health condition studied
Fracture of femur
ICD-10 code
S72.9
ICD-10 code description
fracture of femur, part unspecified

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Befor anesthesia -post Induction -post Intubation -surgery and minute 5-10-15-20-25-30-35-40-45-50-55-60-75 -90-.....
Method of measurement
Blood pressure manometer by mmHg

2

Description
Diastolic blood pressure
Timepoint
Befor anesthesia -post Induction -post Intubation -surgery and minute 5-10-15-20-25-30-35-40-45-50-55-60-75 -90-.....
Method of measurement
Blood pressure manometer by mmHg

3

Description
Mean blood pressure
Timepoint
Befor anesthesia -post Induction -post Intubation -surgery and minute 5-10-15-20-25-30-35-40-45-50-55-60-75 -90-.....
Method of measurement
Blood pressure manometer by mmHg

4

Description
heart rate
Timepoint
Befor anesthesia -post Induction -post Intubation -surgery and minute 5-10-15-20-25-30-35-40-45-50-55-60-75 -90-.....
Method of measurement
Electrocardiogram

5

Description
arterial oxygen saturation
Timepoint
Befor anesthesia -post Induction -post Intubation -surgery and minute 5-10-15-20-25-30-35-40-45-50-55-60-75 -90-.....
Method of measurement
puls oximetry

Secondary outcomes

empty

Intervention groups

1

Description
group 2 : Propofol :50-100mic/kg/min and oxygen, N2o, remifentanyl and muscle relaxants is for anesthesia.
Category
Other

2

Description
group 1:Isofloran: 0.5MAC and oxygen, N2o, remifentanyl and muscle relaxants is for anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating room of Shohada Hospital
Full name of responsible person
Dr.Mortazavi
Street address
Shohada Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research ،Tabriz University of Medical Sciences
Full name of responsible person
Mirmohammadtaghi Mortazavi
Street address
Shohada Hospital
City
Tabriz
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 ،Tabriz 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
Tabriz univercity of medical sciences
Full name of responsible person
Naser Rezapoor
Position
Assistant of anesthesia
Other areas of specialty/work
Street address
Tabriz university of medical sciences Departement of anesthesiology
City
Tabriz
Postal code
5169644589
Phone
+41 13841638
Fax
Email
mortazavimmt@yahoo.com / mortazavimt@tbzmed.ac.ir / rezapoornaser@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shohada Hospital
Full name of responsible person
Mirmohammadtaghi Mortazavi
Position
Assistant professor
Other areas of specialty/work
Street address
Shohada Hospital
City
Tabriz
Postal code
5169644589
Phone
+98 41 1384 1638
Fax
Email
mortazavimmt@yahoo.com mortazavimt@tbzmed.ac.ir rezapoornaser@yahoo.com
Web page address

Person responsible for updating data

Contact

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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