Determination of the Effect of Dexmedetomidine in Comparison with Placebo on Hemodynamic Changes and Patient and Surgeon Satisfaction in Patients with Stereotactic Surgery
Design
Clinical trials are randomized with parallel, blind, randomized groups
Settings and conduct
This study will be conducted at Alzahra Medical Education Center in 1396. The statistical population of the study includes patients undergoing stereotaxic surgery in the center. The medical treatment of both patients in the same group and containing a 10 mg tablet of diazepam the same night before This is a double-blind study. Blind method is that information collector and patients are not aware of the type of drug injected.
Participants/Inclusion and exclusion criteria
Entry requirements: Absence of drugs that affect hemodynamic status and anticoagulants
Conditions of non-arrival: the patient's dissatisfaction for entry
Intervention groups
75 inpatient patients are distributed in 3 groups of 25 people. In the first and second groups, we dilute a 200-μg dose of doxedemotvydine in 50cc normal saline. And in the third group, sulfentanil is used at a rate of 0.1-2.0 μg / kg.
Main outcome variables
Improvement and hemodynamic stability; Positive effects on the supply of myocardial oxygen and the demand for oxygen for oxygen and as a result of myocardial protection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043487N1
Registration date:2019-06-19, 1398/03/29
Registration timing:retrospective
Last update:2019-06-19, 1398/03/29
Update count:0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
negar eghbalifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4523 0321
Email address
negar.eghbalifard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
2017-10-18, 1396/07/26
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
2018-03-19, 1396/12/28
Scientific title
The effect of two different doses of dexmedtomidin compared with sufentanil on hemodynamic changes during stereotaxi surgeries
Public title
the effect of dexmedmotidine compared with sufentanil on surgeon and patient satisfaction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 15 to 65 years
ASA= 2,3
Not receiving drugs that affect hemodynamic status
Not receiving drugs that affect hemodynamic status
Patient agrees to participate in the study
Exclusion criteria:
receiving drugs that affect hemodynamic status
receiving drugs that affect hemodynamic status
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study was block randomized, and 75 patients with the conditions of entry were distributed in 3 groups of 25 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was done double blindly and the method of blindness is that the person collecting the information and the patients are not aware of the type of drug injected.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of medical sciences
Street address
Isfahan University of medical sciences, Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
Ir.mui.rec.1396.3.608
Health conditions studied
1
Description of health condition studied
Stereotactic Surgery
ICD-10 code
G94.8*
ICD-10 code description
Other specified disorders of brain in diseases classified elsewhere
Primary outcomes
1
Description
Hemodynamic status of the patient
Timepoint
Before surgery and every 30 minutes during surgery
Method of measurement
Blood pressure in all patients is performed by a person with a calibration device of the same type. Measuring the level of oxygen saturation and heart rate will be done with a pulse oximeter device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 200 μg dose of dexmedetomidine in 50 ml of normal saline is diluted. The amount of 1 microgram per kg of plow is infused over a 10 minute period. Then, 0.2 μg / kg is given.
Category
Prevention
2
Description
Intervention group: A 200 μg dose of dexmedetomidine in 50 ml of normal saline is diluted. The amount of 1 microgram per kg of plow is infused over a 10 minute period. Then, 0.5 μg / kg is given.
Category
Prevention
3
Description
Control group: Suffentanil is used at a dose of 0.1-0.2 μg / kg as a booster dose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Negar Eghbalifard
Street address
Alzahra hospital,Shohadaye Sofe Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Faraj Zadegan
Street address
Medical School, Hezar Jarib Ave, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Negar Eghbali Fard
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Milad dormitory, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
1831673849
Phone
+98 31 3668 0042
Email
negar.eghbalifard@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negar Eghbali Fard
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Milad dormitory, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8316738491
Phone
+98 31 3668 0048
Email
negar.eghbalifard@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negar Eghbali Fard
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Milad dormitory, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8316738491
Phone
+98 31 3668 0048
Email
negar.eghbalifard@gmail.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
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