Comparison of hemodynamic response during anesthesia induction using Dexmedetomidine and Midazolam in hypertensive patients undergoing orthopedic surgery
Evaluation of hemodynamic changes after dexmedetomidine and midazolam injection in hypertensive anesthesia patients
Design
Clinical trial with 2 intervention groups, with parallel groups, double-blind, randomized, phase 2 on 130 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients in Shohada hospital operating room will be randomly divided into two groups based on a random number table. The intervention group 1, received 10 micro gram per kilogram Dexmedetomidine and the intervention group 2, received 0.03 mg / kg Midazolam. Given that the study is double-blind. Both Dexmedetomidine and Midazolam will be administered to the required number by the planter every morning prior to the start of surgery. Envelope A contains a syringe containing Dexmedetomidine and Envelope B contains Midazolam. Each patient will receive these envelopes on the basis of an A or B code, provided by the anesthesiologist who is unaware of the type of drug as the patient is.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients 40 to 70 years old; known hypertensive treated patients; candidate for elective orthopedic surgery.
Exclusion criteria: patients treated with psychotic drugs; emergency patients; traumatic patients with heavy bleeding; liver and kidney disorders; patients with ischemic heart disease; patients with severe systemic vascular disease.
Intervention groups
Intervention group 1: in the first intervention group, 10 μg / kg dexmedetomidine will be injected 5 minutes before anesthesia.
Intervention group 2: in the second intervention group, 0.03 mg / kg midazolam will be injected 5 minutes before anesthesia.
Main outcome variables
Systolic and diastolic blood pressure; heart rate; saturation of peripheral oxygen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160202026328N6
Registration date:2020-11-22, 1399/09/02
Registration timing:registered_while_recruiting
Last update:2020-11-22, 1399/09/02
Update count:0
Registration date
2020-11-22, 1399/09/02
Registrant information
Name
Masoud Parish
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 5842
Email address
parishm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic response during anesthesia induction using Dexmedetomidine and Midazolam in hypertensive patients undergoing orthopedic surgery
Public title
Comparison of hemodynamic changes in hypertensive patients after dexmedetomidine and midazolam injection
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 40 to 70 years old
Known hypertensive treated patients
Candidate for elective orthopedic surgery
Exclusion criteria:
Patients treated with psychotic drugs
Emergency patients
Traumatic patients with heavy bleeding
Liver and kidney disorders
Patients with ischemic heart disease
Patients with severe systemic vascular disease
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Through a randomly generated computer-generated list, individuals in 4-person blocks will be assigned to two intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the thesis owner student provides the drugs to the anesthesiologist and is the only person who is not blind to the study.The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner. So that anesthesiologist is unaware of the injected drug to patient during injection.The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills in the checklist during surgery and recovery.The patient is also unaware of the type of Injecting drug.
Placebo
Not used
Assignment
Factorial
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
Faculity of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-08-10, 1399/05/20
Ethics committee reference number
IR.TBZMED.REC.1399.540
Health conditions studied
1
Description of health condition studied
Comparison of hemodynamic changes in anesthetized patients with hypertension following dexmedetomidine and midazolam injection.
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
5 minutes before entering the operating room, the moment of entering, 5 minutes after lying down in a relaxed state, immediately after the injection of the intervention drug, 5 minutes after the injection and then every 15 minutes until the end of the operation
Method of measurement
Mercury barometer
2
Description
Diastolic blood pressure
Timepoint
5 minutes before entering the operating room, the moment of entering, 5 minutes after lying down in a relaxed state, immediately after the injection of the intervention drug, 5 minutes after the injection and then every 15 minutes until the end of the operation
Method of measurement
Mercury barometer
3
Description
Heart rate
Timepoint
5 minutes before entering the operating room, the moment of entering, 5 minutes after lying down in a relaxed state, immediately after the injection of the intervention drug, 5 minutes after the injection and then every 15 minutes until the end of the operation
Method of measurement
Counting in each minutes
4
Description
Saturation of peripheral oxygen
Timepoint
5 minutes before entering the operating room, the moment of entering, 5 minutes after lying down in a relaxed state, immediately after the injection of the intervention drug, 5 minutes after the injection and then every 15 minutes until the end of the operation
Method of measurement
Via the Pulse Oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: in the first intervention group, 10 μg / kg dexmedetomidine will be injected 5 minutes before anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group 2: in the second intervention group, 0.03 mg / kg midazolam will be injected 5 minutes before anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Street address
Shohada Hospital, Golshahr Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3517
Fax
+98 41 3389 3517
Email
masoudparish@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research and Technology deputy, Third floor, the headquarter building No 2, Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Masoud Parish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Golshahr Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3517
Fax
+98 41 3389 3517
Email
masoudparish@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Golshahr Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3517
Fax
+98 41 3389 3517
Email
masoudparish@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Golshahr Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3517
Fax
+98 41 3389 3517
Email
masoudparish@yahoo.com
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
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Masoud Parish , Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , masoudparish@yahoo.com
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.