Determining the effect of prescribing a drug regimen including dexmedetomidine and remifentanil, remifentanil on the amount of bleeding during rhinoplasty.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. A table of random numbers is used for randomization.
Settings and conduct
Patients referred to the operating room of Shafa Hospital in Kerman are selected for rhinoplasty, and after induction of anesthesia and allocation of patients to two control groups (remifentanil) and intervention group (dexmedetomidine and remifentanil), hemodynamic indicators and the amount of bleeding during the operation are evaluated. In the meantime, the surgeon and the outcome assessor are blind, and only the anesthesiologist is aware of the type of drug allocation.
Participants/Inclusion and exclusion criteria
Entry requirements: Adults between 18 and 50 years of age who are candidates for rhinoplasty surgery
Exit conditions: patients with physical class higher than 2؛ patients with systolic blood pressure less than 100 mmHg or heart rate less than 60 per minute؛ patients with relative or absolute prohibition of general anesthesia؛ Patients with chronic use of drugs or alcohol and special use of any type of interfering drug during anesthesia.
Intervention groups
Intervention group: receiving dexmedetomidine with a loading dose of 1.0-0.5 μg/kg and a maintenance dose (0.5-0.3 μg/kg/h) and remifentanil with a maintenance dose (0.5-0.25 mcg/kg/min IV) in the form of infusion.
Control group: receiving remifentanil with a maintenance dose (0.25-0.5 mcg/kg/min IV
Main outcome variables
Bleeding volume؛ blood pressure؛ heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221202056688N1
Registration date:2022-12-17, 1401/09/26
Registration timing:prospective
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Elnaz Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 1111
Email address
elnaz_rahmani26@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of medication including dexmedetomidine + remifentanil VS remifentanil on bleeding during rhinoplasty surgery
Public title
Investigating the effect of the combination of a cardiovascular drug and an anesthetic drug on the amount of bleeding during nose surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Rhinoplasty surgery candidate
No history of nose surgery
Not suffering from chronic and severe diseases (diabetes, high blood pressure, cancer, etc.)
patients with physical class higher than 2
Exclusion criteria:
Patients with systolic blood pressure less than 100 mm Hg
Heart rate less than 60 per minute
Patients with relative or absolute prohibition of general anesthesia
Patients with chronic drug or alcohol use
Specific use of any interfering drug during anesthesia
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and using a table of random numbers. First, the direction of reading the numbers in the table is determined, then we move by placing our hands on a number and according to the predetermined reading direction, even numbers represent the intervention group and odd numbers represent the group. The control is used to hide sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is in such a way that only the anesthesiologist is aware of the type of drug used, and the patients, the outcome assessor, and the surgeon are unaware of the grouping and type of drugs.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences Campus, The beginning of Haft Bagh Alavi Road, Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-08-02, 1401/05/11
Ethics committee reference number
IR.KMU.REC.1401.163
Health conditions studied
1
Description of health condition studied
The amount of bleeding during rhinoplasty surgery
ICD-10 code
Z42.0
ICD-10 code description
Follow-up care involving plastic surgery of head and neck
Primary outcomes
1
Description
Bleeding volume
Timepoint
After the operation is completed
Method of measurement
Calculating the amount of blood in the suction, sterile gases and the surgeon's satisfaction with the surgical field
2
Description
blood pressure
Timepoint
Before the operation, 15-30-45 minutes after the start of the intervention and the end of the operation
Method of measurement
By monitoring the patient's vital signs
3
Description
Heart rate
Timepoint
Before the operation, 15-30-45 minutes after the start of the intervention and the end of the operation
Method of measurement
By monitoring the patient's vital signs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving dexmedetomidine with a loading dose of 1.0-0.5 μg/kg and a maintenance dose (0.5-0.3 μg/kg/h) and remifentanil with a maintenance dose (0.5-0.25 mcg/kg/min IV) in the form of infusion. will receive
Category
Treatment - Drugs
2
Description
Control group: receiving remifentanil with a maintenance dose (0.25-0.5 mcg/kg/min IV)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Elnaz Rahmani
Street address
Shafa hospital, Shafa Street, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5810
Email
kmu.nrc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpoor Afshar
Street address
Somayeh crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Elnaz Rahmani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Havanirooz
City
Kerman
Province
Kerman
Postal code
7618187568
Phone
+98 34 3285 0395
Email
elnaz_rahmani26@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Jafar Salehi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Gharani
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
dr.jsalehi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Elnaz Rahmani
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Havanirooz
City
Kerman
Province
Kerman
Postal code
7618187568
Phone
+98 34 3285 0395
Email
elnaz_rahmani26@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
It is possible to share all data without mentioning people's names and privacy.
When the data will become available and for how long
2 months after data analysis
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Elnaz Rahmani- Email: elnaz_rahmani26@yahoo.com
What processes are involved for a request to access data/document