The aim of this study was to determine and compare the hemodynamic parameters (systolic and diastolic blood pressure; mean blood pressure ;heart rate;o2 saturation) during the steriotaxic surgeries in two groups of recieving dexmedtomidine and fentanyl.
Design
This clinical trial is randomized, without any control group, with parallel and double-blind groups.
Settings and conduct
This study was performed in Al-Zahra Medical Center in Isfahan.Participants were selected from elective patients with stereotaxic surgery after evaluating the inclusion and exclusion criteria and randomly and double blindly(patients and physician) were placed in the group receiving fentanyl or dexmedetomidine. Hemodynamic parameters were measured before and after every 30 minutes after anesthesia and during recovery. The anesthesia technician provides the drugs to the physician in similar syringes and the anesthesiologist and patients are informed of the groups and names of the drugs. Do not have.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Age between 18 and 65 years old; Patient with American Society of Anesthesiology physical status class 1,2 (ASA I,II).
Non- inclusion criteria :patients recieve anticoagulant drugs ; patients recieve drugs affect on hemodynamic status;patients with bradycardia and heart block
Intervention groups
Intervention group 1: group A(patients recieve fentanyl). they receive 2 microgram per kilogram of body weight fentanyl. Intervention group 2 : group B (patients recieve dexmedtomidine) they receive loading dose 1 microgram per kilogram of body weight in 10 minutes then maintenance dose 0.5 microgram per kilogram of body weight per hour dexmedtomidine .
Main outcome variables
Systolic blood pressure; diastolic blood pressure; mean blood pressure; heart rate; saturation of o2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110528006617N5
Registration date:2021-01-30, 1399/11/11
Registration timing:retrospective
Last update:2021-01-30, 1399/11/11
Update count:0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
Mehrdad Masoudifar
Name of organization / entity
Esfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1268 2007
Email address
masoudifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of fentanyl and dexmedtomidine on hemodynamic changes during stereotaxic surgeries
Public title
The effect of dexmedtomidine and fentanyl on hemodynamic indicies in Stereotaxic surgeries.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age btween 18-65 years old
Patients who consent to the informed consent to participate in the study.
Patient with american society of anesthesiology physical status class 1,2(ASA I,II)
Exclusion criteria:
Patients who have bradycardia and heart block.
Patients who have anticoagulant drugs.
Patients who have drugs affect on hemodynamic status.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Random function "Random Number Generation " of Excel software based on patient file number will be used for randomization. Patients file number were entered into Excel program and patients were divided into case and control groups based on the random button. In total, there were two groups of 68 people. In this case, the file number is entered in Excel program, then a random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 34 people in each group. As a result, sequences 1 to 2 should be repeated 34 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 34 for repeating the sequence. In this way, 68 units will be produced
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient information is hidden by the operating room nurse and injectable drugs are also provided to the physician in similar syringes by an anesthetic technician, while the physician will not have any knowledge concerning the substance in the syringe. In addition, the participants will not be informed about the injectable drugs in each syringe and the names of the operating room personnel.
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
8174673461
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.MUI.REC.1398.122
Health conditions studied
1
Description of health condition studied
General Anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic blood pessure
Timepoint
Before intervention and 30,60,90,120 minutes after intervention and recovery time
Method of measurement
Mm-hg, sphygmomanometer
2
Description
Diastolic blood pressure
Timepoint
Before intervention and 30,60,90,120 minutes after intervention and recovery time
Method of measurement
Mm-hg, sphygmomanometer
3
Description
Heart rate
Timepoint
Before intervention and 30,60,90,120 minutes after intervention and recovery time
Method of measurement
ECG monitor
4
Description
Mean arterial pressure
Timepoint
Before intervention and 30,60,90,120 minutes after intervention and recovery time
Method of measurement
Mm-hg, sphygmomanometer
5
Description
O2 saturation
Timepoint
Before intervention and 30,60,90,120 minutes after intervention and recovery time
Method of measurement
O2 saturation percentage , pulse oximeter device
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Initially,personal consent is obtained from the patients.Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached .Then 2 micrigram per kilogram fentanyl is injected.
Category
Treatment - Drugs
2
Description
The second intervention group: Initially,personal consent is obtained from the patients.Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry,capnography are attached .Then 1 micrigram per kilogram dexmedtomidine is infused in 10 minutes and then 0.5 microgram per kilogram per hour dexmedtomidine is infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahrah hospital
Full name of responsible person
Mehrdad Masoudifar
Street address
Soffeh boulivard, shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Masoudifar@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan university of medical sciences
Full name of responsible person
Shaghayegh haghjoo
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mina Foroughi
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.35 , Allahoakbar Ave., Jey Street
City
Isfahan
Province
Isfehan
Postal code
8159665399
Phone
+98 31 3528 4210
Email
Mina.f1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
Masoudifar@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Foroughi
Position
Medical student / Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.35, Allahoakbar Ave., Jey Street
City
Isfahan
Province
Isfehan
Postal code
8159665399
Phone
+98 31 3528 4210
Email
Mina.f1994@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