To survive of the effect of Intravenous amino acid infusion prevents hypothermia during surgery under spinal anesthesia on reducing the degree of hypothermia and postoperative shivering
Design
This is a randomized, controlled, double-blinded clinical trial that 36 adults undergoing Hip Arthroplasty were randomly assigned into two groups of 18 each.
Settings and conduct
patients who were scheduled for elective primary hip arthroplasty, in Imam Reza Hospital, Mashhad, Iran were entered in this study.
Participants/Inclusion and exclusion criteria
candidate to hip arthroplasty during Spinal Anesthesia
Intervention groups
Intervention group: Before induction,the patients received 150 cc per hour of 10% amino acid.
Control group: Ringer serum 150 cc per hour before induction.
Main outcome variables
The dermatome level of blockade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N5
Registration date:2018-01-30, 1396/11/10
Registration timing:retrospective
Last update:2018-01-30, 1396/11/10
Update count:0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-09-19, 1391/06/29
Expected recruitment end date
2015-04-29, 1394/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Amino Acid Infusion preventive effect on Hypothermia during Spinal Anesthesia for Hip Arthroplasty
Public title
Evaluation of Amino Acid Infusion preventive effect on Hypothermia during Spinal Anesthesia for Hip Arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidated to hip arthroplasty
Undergoing spinal anesthesia
Exclusion criteria:
Primary coagulation disorder
Diabetic
Secondary hip arthroplasty
consuming of NSAIDS drugs
sensitive to amino acids
Consuming Atropin before surgery
Age
From 16 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by simple methods, the tools used in randomization was table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the investigator and patients are unaware from the type of drug. Blinding was done by closed envelopes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944-
Approval date
2010-09-29, 1389/07/07
Ethics committee reference number
89282
Health conditions studied
1
Description of health condition studied
Spinal Anesthesia
ICD-10 code
F44.6
ICD-10 code description
Conversion disorder with sensory symptom or deficit
Primary outcomes
1
Description
Heart rate
Timepoint
during surgery
Method of measurement
Using an electrocardiogram or ECG device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The amino acid(10%) of an hour before anesthesia starts at 240 kJ / hr and continue until the end of surgery.
Category
Prevention
2
Description
Control group: Ringer Serum Injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
peivandia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 3363
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518022711
Email
rajaeim931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
golhasanif1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
golhasanif1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
proposal
When the data will become available and for how long
1 month
To whom data/document is available
Email
Under which criteria data/document could be used
Researcers of University
From where data/document is obtainable
sent an Email to Rajaeim931@mums.ac.ir
What processes are involved for a request to access data/document