Comparison of general anesthesia with sevoflurane and low-dose spinal anesthesia with 5% lidocaine on hemodynamic signals in patients undergoing hip fracture
This is a randomized clinical trial study, to evaluate and compare the two methods of general anesthesia with Sevoflurane, and spinal anesthesia with low-dose of Lidocaine 5% in patients that undergoing hip fracture surgery.Sample size for this study is100 patients. Patients randomized with Block Randomization in two groups, General anesthesia (GA ) and Spinal anesthesia(SA).In General anesthesia (GA) group, after Oxygenation mask , induction with Fentanyl, followed by Propofol until loss of consciousness, then Atracorium administered.Anesthesia maintening is Sevoflurane in Oxygen and Nitrous Oxide in the spinal group, Lidocaine 5%(1.5 cc) inject and for sedation 1 mg Midazolame and 50 microgram Fentanyl. Vital sign such as Heart rate, systolic and diastolic pressure measure every 15 minutes and in the end of surgery bleeding volume is recorded. Inclusion criteria: patients older than 30 years old with class ASA 1-3, who schedule for elective operative fixation of fractured hip.Exclusion criteria include: dementia ; congnitive dysfunction; history of Opioid or psychotic drug use.Patients with hupersensitivity to anesthetic drugs; Sever liver and kidney Diseases; sever bleeding; hypotention needed to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308316280N4
Registration date:2014-03-15, 1392/12/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-15, 1392/12/24
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-03-16, 1392/12/25
Expected recruitment end date
2014-09-16, 1393/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of general anesthesia with sevoflurane and low-dose spinal anesthesia with 5% lidocaine on hemodynamic signals in patients undergoing hip fracture
Public title
Hemodynamic effects of general and spinal anesthesia for hip fracture surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:aged over 30; ASA class 1-3 with hip fracture fixation surgery
Exclusion criteria: Dementia or cognitive dysfunctions and no history of opioid or psychotic drugs use; Patients with hypersensitivity to anesthetic drugs; sever liver,kidney and pulmonary diseases; sever bleeding; hypo-tension that requiring treatment
Age
From 30 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics Committee of GuilanUniversity of Medical Sciences
Street address
Shahid Beheshti freeway
City
Rasht
Postal code
4193893345
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
1920341306
Health conditions studied
1
Description of health condition studied
Hip fracture
ICD-10 code
S72.2
ICD-10 code description
Subtrochanteric fracture
Primary outcomes
1
Description
Bleeding
Timepoint
End of surgery
Method of measurement
ml/ numbers of bloody Gauze
2
Description
Blood Pressure
Timepoint
0-15-30-45-60 times and every 15 minutes during the recovery up to 24 hours
Method of measurement
mmHg/ saadat company
3
Description
Heart Rate
Timepoint
0-15-30-45-60 times and every 15 minutes during the recovery up to 24 hours
Method of measurement
The number in the Minutes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Spinal Anesthesia with Low-dose lidocaine
5%
Category
Treatment - Drugs
2
Description
Intervention 2: General anesthesia with sevoflurane
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Mohammad Haghighi
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
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 of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Anesthesiologist/associated Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1323 9842
Email
mohaghighi@gums.ac.ir, arcguilan1392@gmail.com
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Anesthesiologigs/associated professor
Other areas of specialty/work
Street address
Poursina hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5140
Email
mohaghighi@gums.ac.ir,arcguilan1392@gmail.com
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Bachelor's Degree/ Medical laboratory Sciences Technician
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
nematihedieh@gmail.com, arcguilan1392@gmail.com
Web page address
www.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)