This study compared the effects of Bupivacaine and Lidocaine - Bupivacaine on hemodynamic parameters in patients with hip fracture surgery. Inclusion criteria: 60-70 years old patients with ASA I-III that candidate for hip surgery. Contraindications of spinal anesthesia or uncontrolled Hypertension, ischemic heart disease, heart failure, recent myocardial infarction (MI) or active ischemia in Electrocardiography (ECG) do not enter the study. Patients are divided randomly into 2 groups, A (10 mg Bupivacaine 0.5% ) and B (5 mg Bupivacaine 0.5% + 50 mg Lidocain 5%), 0.2 mg Epinephrine is added to both groups. Then blood pressure, heart rate, sensory and motor blocks before spinal anesthesia and immediately after spinal anesthesia are checked every 5 minutes until 30 minutes. Numbers of hypotension, total dose of vasopressors and nausea and vomiting are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102713456N2
Registration date:2014-12-07, 1393/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
Abbas Sedighinejad
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 132 5712
Email address
a_sedighinejad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2016-06-23, 1395/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of Bupivacaine and Lidocaine - Bupivacaine on hemodynamic parameters in patients with hip fracture surgery
Public title
Hemodynamic control on spinal patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : 60-70 years old patients with ASA I-III that candidate for hip surgery. contraindications of spinal anesthesia or uncontrolled Hypertension, ischemic heart disease, heart failure, recent myocardial infarction (MI) or active ischemia in Electrocardiography( ECG) do not enter the study
Age
From 60 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
133
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 Guilan university of Medical Science
Street address
Namjoo Street
City
Rasht
Postal code
4193893345
Approval date
2014-08-26, 1393/06/04
Ethics committee reference number
1930231617
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Systolic blood pressure less than 90 mmHg or redused mean artherial pressure more than 25%
Timepoint
Immediately after the injection then every 5 minutes up to 30 minutes
Method of measurement
mmHg by Saadat monitoring system
2
Description
Heart Rate
Timepoint
Immediately after the injection then every 5 minutes upto 30 minutes
Method of measurement
Beats per minute (bpm) by Saadat monitoring system
Secondary outcomes
1
Description
Nausea
Timepoint
Immediately after the injection then every 5 minutes up to 30 minutes
Method of measurement
Nausea score (0-4)
Intervention groups
1
Description
Intervention 1) 1 milligram Bupivacaine 0.5%
Category
Treatment - Drugs
2
Description
Intervention 2) Five milligram Bupivacaine 0.5% with 50 milligram Lidocaine 5%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Abbas Sedighinejad
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
Abbas Sedighinejad
Position
Anesthesiologist/ Associated Professor
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist/Assosiated proffessor
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.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
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)