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Comparison effect of fentanyl and dexmedtomidin , on hemodynamic changes during craniotomy surgeries

Protocol summary

Study aim
Comparison of the effect of fentanyl and dexmedmotidine on hemodynamic changes in patients undergoing brain tumor surgery
Design
In this study, 70 patients undergoing brain tumor surgery by random allocation method were distributed in two groups of 35, in the first group during the course of the action of doxedmodyntidine and in the second group, fentanyl is injected. The hemodynamic parameters of patients include blood pressure, heart rate and blood oxygen saturation before and after each operation, and then every 30 minutes during recovery and operation. Levels of blood gaz are determined and recorded in patients before and after surgery. Finally, the findings of the two groups are compared.
Settings and conduct
This double-blind clinical trial is conducted in 1398 in Al-Ahra Hospital in Isfahan. 70 patients undergoing brain tumor surgery are divided into two groups of 35, in the first group, dexamethmonidine, and in the second group fentanyl, is injected immediately after induction of anesthesia. The hemodynamic variables and coagulation factors are determined and compared in both groups during operation and recovery.
Participants/Inclusion and exclusion criteria
In this study, patients undergoing bran tumor surgery with an age range of 18-65 years, ASA = 2.3, who did not receive medications that affect hemodynamic status and anticoagulant drugs and who agree to participate in the study, are included in the study.
Intervention groups
In this study, the intervention group was the patients receiving doxedetomidine and the control group receiving fentanyl. In the first group, 0.1 ug /kg doxedetomidine and the second group 5 mg/kg fentanyl are injected immediately after induction of anesthesia.
Main outcome variables
blood pressure, heart rate, O2sat, cuagulation factore

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130311012782N32
Registration date: 2019-07-15, 1398/04/24
Registration timing: prospective

Last update: 2019-07-15, 1398/04/24
Update count: 0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of fentanyl and dexmedtomidin , on hemodynamic changes during craniotomy surgeries
Public title
Comparison of two drugs of dexmedetomidin and fentanyl of bloosd pressure and heart rate in brain tumor surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age range 18-65 years ASA=II.III not receive drugs effect on hemodynamic status not receive anti coagulant drugs agree for participant in the study
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are distributed in two groups using random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blindness will be that the patient and the researcher are not aware of the type of drug they receive. The drugs will be provided by a person from the operating room will provided in the same or encoded syringes and receive by researcher for injection
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
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
ir.mui.rec.1396.3.694

Health conditions studied

1

Description of health condition studied
brain tumor
ICD-10 code
C71.0
ICD-10 code description
Malignant neoplasm of cerebrum, except lobes and ventricles

Primary outcomes

1

Description
Blood Pressure
Timepoint
Every 15 minutes during surgery and recovery
Method of measurement
Palsoxymetery

Secondary outcomes

1

Description
Coagulation Profile
Timepoint
before and after operation
Method of measurement
Take the blood sample and send it to the lab

Intervention groups

1

Description
Intervention group: receive dexmedetomidin 0.1 ug/kg immediately after induction
Category
Prevention

2

Description
Control group: receive 5 mg/kg fentanyl immediatly after induction
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Zohrea Rahimi
Street address
Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Fax
+98 31 3669 2174
Email
zohre.rahimi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
research faculty of isfahan university of medical sciences, hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3070
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
396694
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
Zohrea Rahimi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Department of Anesthesiology, Alzaha Hospitla, Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Fax
+98 31 3669 2174
Email
zohrea.rahimi@google.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Taghi Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Fax
+98 31 3669 2174
Email
st_hashemi@med.mui.acir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
researcher
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research Faculty, School of Medicine, Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 8081
Email
al.mehrabi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information belongs to the government.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Because the information belongs to the government, it is not possible to share it.
When the data will become available and for how long
not applicable
To whom data/document is available
no one
Under which criteria data/document could be used
Medical University license
From where data/document is obtainable
no one
What processes are involved for a request to access data/document
no procedure
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