The Effect of Dexmedetumidine on Hypertension in Patients with Hypertension after Laparatomy Surgery
Design
Double blind randomized clinical trial
Settings and conduct
This study was performed on 80 ASA class II-III patients aged 17-70 years who had a history of hypertension (hypertension above 150/90 mmHg) and were candidates for elective laparatomy after obtaining informed consent from the patient and the university's ethical committee. The fact that the patient can withdraw from the project at any time will be carried out at the Imam Reza Hospital in Tabriz. The patient will be given an anesthetic induction and the same anesthesia will continue. The patients (group D) 15 minutes before the end of the operation (beginning of abdominal cavity) 0.5 mic g / kg dilatated dexmedotomidine in 5 ml normal saline and in the control or control group (S) the amount of normal saline was only slow IV injections. The blood pressure is measured before and after the injection. After the extubation, the patient is transferred to the recovery with spontaneous respiration and is monitored and oxygenated with a face mask. Blood pressure and pain in the patient as well as agitation in both groups are recorded in the leaf. After confirming the recovery and emergency anesthetic expert, the patient is taken to the bracelet and again the blood pressure and agitation are first recorded every 15 minutes (up to 2 hours) and then every 2 hours.
Participants/Inclusion and exclusion criteria
Inclusion: hypertension history; laparotomy surgery history; has not addiction.
No entry: patient refusal; opiate addiction.
Intervention groups
The intervention group who received Dexmedetomidine and control group who receive normal salin (placebo)
Main outcome variables
Blood pressure; pain; agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150217021121N3
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Reza Movassaghi Gargari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 8740
Email address
movassaghir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-25, 1396/04/04
Expected recruitment end date
2018-04-22, 1397/02/02
Actual recruitment start date
2017-08-06, 1396/05/15
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Effect of intravenous dexmedetomidine on control of blood pressure after laparotomy surgery in hypertensive patients
Public title
Dexmedetomidine after laparotomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of hypertension
Candidate for elective laparotomy
Exclusion criteria:
Age under 18 and over 70 years old
Addiction
Severe systemic disabling
Mental illness and chronic pain disorders
Patients with ASA class III and more and patient refusal
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
76
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly divide the patients into two groups, Random Allocation Software was used.And the patients were divided into two groups of control and medication
Blinding (investigator's opinion)
Double blinded
Blinding description
The surgeon and the patient do not know the type of group in this study, but the anesthetist knows about this study and the drugs and after examining the case number and the patient's name and medications will checked
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital Golghasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165739431
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
ir.tbzmed.rec.1397.343
Health conditions studied
1
Description of health condition studied
Blood pressure after laparotomy surgery in hypertensive patients
ICD-10 code
I10
ICD-10 code description
Hypertension
Primary outcomes
1
Description
Controlling of blood pressure after laparotomy surgery in hypertensive patients
Timepoint
It is first recorded every 15 minutes (up to 2 hours) and then every 2 hours after the operation
Method of measurement
Mercury pressure gauge device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the patients studied group ,15 minutes before the end of surgery (starting to close the abdomen) 0.5 mic g / kg dexmedetomidine diluted in 5 ml of normal saline , slowly IV injected .
Category
Prevention
2
Description
Control group: In the control group ,15 minutes before the end of surgery (starting to close the abdomen) only 5 ml of normal saline , slowly IV , injected.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Reza Movassaghi Gargari
Street address
Imam Reza Hospital Golghasht Avn
City
Tabriz
Province
East Azarbaijan
Postal code
5165739431
Phone
+98 41 3336 8740
Email
movassaghir@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ata Mahmoudpor (Deputy of research and technology)
Street address
Tabriz University of Medical sciences,Medicine Faculty,Department of Anesthesiology
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 8740
Email
rz_movassaghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Movassaghi
Position
Associate professor of Department of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Faculty of Medicine,Tabriz University of Medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 8740
Email
rz_movassaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Movassaghi gargari
Position
Associate Professor of Department of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Faculty of Medicine,Tabriz University of Medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
0098 41 33368740
Email
rz_movassaghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Movassaghi Gargari
Position
Associate Professor of Department of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Faculty of Medicine,Tabriz University of Medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165739431
Phone
+98 41 3336 8740
Email
rz_movassaghi@yahoo.com
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
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
Undecided - It is not yet known if there will be 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
dexmedetomidine study data
When the data will become available and for how long
Data will be inaccessible to the public
To whom data/document is available
Those who request access to data
Under which criteria data/document could be used
Data will be available for use in meta-analysis
From where data/document is obtainable
first author
What processes are involved for a request to access data/document