Protocol summary

Study aim
The effect of different doses of bolus dexmedetomidine to create controlled hypotension and the incidence of bradycardia in rhinoplasty surgery.
Design
This study is randomized clinical trial in which the number of patients is determined according to the sample size formula . The code is given and patients are randomly assigned to three treatment groups, with random code selection.The number of patients is 30 patients.
Settings and conduct
In this study, which is performed as a clinical trial in Firoozgar Hospital, patients are randomly divided into three groups after obtaining informed consent. After entering the operating room, all patients are monitored by EKG, NIBP, SPO2 and BIS, and the initial vital signs are recorded. After induction of anesthesia according to the standards, In the first group, dexmedetomidine is injected at a dose of 1 µ/kg for 10 minutes. In the second group, we inject dexmedetomidine at a dose of 9/0 µ/kg , and in the third group, we inject dexmedetomidine at a dose of 8/0 µ/kg. After 5 minutes and also at the end of 10 minutes, the patient's vital signs are recorded and the effect of the intervention on the study variables is investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA1 and ASA2 anesthesia score, The average age between 18 and 50 years. Exclusion criteria: Patient dissatisfaction with participating in the study, Not having blood pressure.
Intervention groups
In the first group, dexmedetomidine is injected at a dose of 1 µ/kg for 10 minutes. In the second group, we inject dexmedetomidine at a dose of 9/0 µ/kg , and in the third group, we inject dexmedetomidine at a dose of 8/0 µ/kg.
Main outcome variables
Moderate arterial blood pressure, Blood Pressure, Heart rate, Amount of bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191110045388N1
Registration date: 2020-04-29, 1399/02/10
Registration timing: registered_while_recruiting

Last update: 2020-04-29, 1399/02/10
Update count: 0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Soudabeh Djalali Motlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1360
Email address
djalalimotlagh.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different doses of bolus dexmedetomidine to create controlled hypotension and the incidence of bradycardia in rhinoplasty surgery.
Public title
The effect of different doses of bolus dexmedetomidine to create controlled hypotension and the incidence of bradycardia in rhinoplasty surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA1 and ASA2 Anesthesia score. The average age between 18 and 50 years.
Exclusion criteria:
Patient dissatisfaction with participating in the study Not having blood pressure
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2019-09-09, 1398/06/18
Ethics committee reference number
IR.IUMS.FMD.REC.1398.280

Health conditions studied

1

Description of health condition studied
Rhinoplasty
ICD-10 code
J34
ICD-10 code description
Other and unspecified disorders of nose and nasal sinuses

Primary outcomes

1

Description
Blood pressure
Timepoint
During Surgery
Method of measurement
Barometer

2

Description
Heart Rate
Timepoint
During Surgery
Method of measurement
Pulse Oximeter

Secondary outcomes

1

Description
Bleeding during surgery
Timepoint
During Surgery
Method of measurement
Blood volume measurement

Intervention groups

1

Description
Intervention group: In the first group, dexmedetomidine is injected at a dose of 1 µ/kg within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.
Category
Treatment - Drugs

2

Description
Intervention group:In the second group, dexmedetomidine is injected at a dose of 9/0 µ/kg within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.
Category
Treatment - Drugs

3

Description
Intervention group: In the third group, dexmedetomidine is injected at a dose of 8/0 µ/kg within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Soudabeh Djalali Motlagh
Street address
Unit G3, No.1 South 2nd St. Saadat Abad Ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8214 1360
Email
djalalimotlagh.s@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research & Technology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8894 6762
Email
djalalimotlagh@icloud.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Soudabeh Djalali Motlagh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit G3, No.1 South 2nd St. Saadat Abad Ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8214 1360
Email
djalalimotlagh@icloud.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Unit G3, No.1 South 2nd St. Saadat Abad Ave.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8214 1360
Email
Sara_saadat_8@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Unit G3, No.1 South 2nd St. Saadat Abad Ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8214 1360
Email
h_bf69@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
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
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