Effect of dexmedetomidine infusion on N-terminal pro-B-type natriuretic peptide level in patients with femoral shaft fractures under general anesthesia
Objectives: The aim of this study is to determine the effects of dexmedetomidine on NT-pro-BNP levels and hemodynamic parameters of patients with femoral shaft fractures who candidate for elective surgery under general anesthesia.
Design: In a double blind clinical trial study, 50 patients who candidate for femoral shaft fracture elective surgery will be enrolled They will be divided randomly in two groups.
Setting and conduct: This study will be conducted in anesthesiology department of Imam Hosein Hospital, Tehran, Iran.
Participants including major eligibility criteria: 15-55 years old patients with ASA Class I, II will be enrolled. Patients with positive history of any cardiac or hepatic problem; addiction to any specific drug; using anti hypertensive, psychiatric, agonist or antagonist α-2 receptor agents; basal heart rate less than 60/min; pregnant patient; patients who had blood loss of more than 1 liter during surgery; patients for whom the time of operation took more than 3 hours will be excluded.
Intervention: In the dexmedetomidine group 0.5 μg/kg/h of this drug will be infused during the time of operation.In the control group the same volume of 0.9% sodium chloride will be infused. Two blood samples were taken before induction of anesthesia and 24 hours after operation for NT-pro-BNP level assessment.
Main outcome measures: NT-pro-BNP levels before and after surgery will be compared. Trend of change in SBP, DBP, and PR between the two groups will also be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511279593N2
Registration date:2015-12-27, 1394/10/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Elham Memary
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8082
Email address
drmemary@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dexmedetomidine infusion on N-terminal pro-B-type natriuretic peptide level in patients with femoral shaft fractures under general anesthesia
Public title
Effect of dexmedetomidine infusion on N-terminal pro-B-type natriuretic peptide level
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patients with femoral shaft fracture who were candidates for elective surgery under general anesthesia; between 15 and 55 years; ASA Class I, II
Exclusion criteria: positive history of any cardiac or hepatic problem; addiction to any specific drug; using anti hypertensive, psychiatric, agonist or antagonist α-2 receptor agents; basal heart rate less than 60/min; pregnant patient; patients who had blood loss of more than 1 liter during surgery; patients for whom the time of operation took more than 3 hours
Age
From 15 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-06-18, 1393/03/28
Ethics committee reference number
0400/2044
Health conditions studied
1
Description of health condition studied
Fracture of femural shaft
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
NT pro BNP
Timepoint
before induction and 24 hours after surgry
Method of measurement
blood level
Secondary outcomes
1
Description
systolic blood pressure
Timepoint
every 30 min from induction until end of surgry
Method of measurement
based on mmHg
2
Description
diastolic blood pressure
Timepoint
every 30 min from induction until end of surgry
Method of measurement
based on mmHg
3
Description
pulse rate
Timepoint
every 30 min from induction until end of surgry
Method of measurement
per minute
Intervention groups
1
Description
infusion of dexmedetomidine hydrochloride as 0.5µg/kg/h diluted in normal saline
Category
Treatment - Drugs
2
Description
same volume of normal salin as dexmedetomidine group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Dr. Elham Memary
Street address
Shahid Madani Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ُShahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memari
Street address
Yemen Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ُShahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Hosein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Behshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Hosein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Behshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistan Professor
Other areas of specialty/work
Street address
Imam Hosein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)