Comparison of the effect of intravenous nitroglycerine versus placebo the hemodynamic responses in patients undergo elective non-cardiac surgery: a double blind randomized clinical trial
To compare the effect of intravenous nitroglycerine versus placebo the hemodynamic responses in patients undergo elective non-cardiac surgery
Design
This is a double-blind randomized clinical trial, in which 78 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergo elective non-cardiac surgery who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Candidate for elective non-cardiac surgery;
Weight less than 100 kg
Exclusion criteria:
Using anti-hypertensive or anti-depressive drugs;
Hyperthyroidism or hypothyroidism;
Diabetes, renal failure, heart failure, or liver disorder;
A history of myocardial infarction;
Hypotension;
Bradycardia
Intervention groups
Intervention group 1:
Intravenous nitroglycerine 1 mic g/kg as single-dose before surgery
Intervention group 2:
Intravenous nitroglycerine 2 mic g/kg as single-dose before surgery
Control group:
Intravenous normal saline 5 ml as single-dose before surgery
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous nitroglycerine versus placebo the hemodynamic responses in patients undergo elective non-cardiac surgery: a double blind randomized clinical trial
Public title
Comparison of the effect of intravenous nitroglycerine versus placebo the hemodynamic responses in patients undergo elective non-cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Candidate for elective non-cardiac surgery;
Weight less than 100 kg
Exclusion criteria:
Using anti-hypertensive or anti-depressive drugs;
Hyperthyroidism or hypothyroidism;
Diabetes, renal failure, heart failure, or liver disorder;
A history of myocardial infarction;
Hypotension;
Bradycardia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1, on two sheets the name of the intervention 2 and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-08-20, 1397/05/29
Ethics committee reference number
IR.UMSHA.REC.1397.297
Health conditions studied
1
Description of health condition studied
blood pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
2
Description of health condition studied
heart rate
ICD-10 code
O76
ICD-10 code description
Abnormality in fetal heart rate and rhythm complicating labor and delivery
Primary outcomes
1
Description
Measuring systolic blood pressure
Timepoint
Before and 1, 3, 5 and 10 minutes after intubation
Method of measurement
Using sphygmomanometer
2
Description
Measuring diastolic blood pressure
Timepoint
Before and 1, 3, 5 and 10 minutes after intubation
Method of measurement
Using sphygmomanometer
3
Description
Measuring heart rates
Timepoint
Before and 1, 3, 5 and 10 minutes after intubation
Method of measurement
Using monitor machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intravenous nitroglycerine 1 mic g/kg as single-dose before surgery
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous nitroglycerine 2 mic g/kg as single-dose before surgery
Category
Treatment - Drugs
3
Description
Control group: Intravenous normal saline 5 ml as single-dose before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan C
Full name of responsible person
Shabnaz Sharifi
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Shabnaz.sharifi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shabnaz Sharifi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Shabnaz.sharifi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Pooran Hajian
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
pooranhajian567@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available