to investigate hemodynamic changes in the injection of Remifentanil with Labetalol, combined with Propofol in nasal endoscopy
Design
randomized trial; without blinding; in parallel; has a control group; Phase 3; Randomization using colored cards
Settings and conduct
It is performed on patients who are candidates for nose surgery and who refer to educational-therapeutic centers of Qazvin University of Medical Sciences and are included in the study randomly without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study; aged between 15 and 60 years; no history of surgery; Not having a chronic mental or physical illness; Not having vision and hearing problems and other disabilities; Absence of allergy to Remifentanil, Profol or Labtalol; Absence of pregnancy, breastfeeding or abortion less than three months. Exclusion criteria: Unwillingness to cooperate in the study;
Heart diseases and HTN; Liver diseases.
Intervention groups
Patients who met the necessary conditions, after full training by an Anesthesiologist and filling in the patient's informed personal consent form, entered the study and randomly entered into one of the two test groups A (Remifentanil in combination with Propofol) and test group B (Labetalol in combination with Propofol) be.
Investigating the effect of Remifentanil and Labtalol, in combination with Propofol, on hemodynamic changes in nasal endoscopy
Public title
Investigating the effect of Remifentanil and Labtalol on hemodynamic changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study
The age of the person should be between 15 and 60 years
There is no history of surgery and it is the patient's first surgery
Not having a chronic mental or physical illness (schizophrenia, diabetes, etc.)
Not having vision and hearing problems and other disabilities
No allergy to Remifentanil, Profol and Labtalol
Absence of pregnancy, breastfeeding and abortion less than 3 months
Exclusion criteria:
Heart diseases and HTN
Liver diseases (cirrhosis, hepatitis, etc.)
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the necessary conditions, after completing the personal informed consent form to the trial in a simple random manner using blue and red color cards placed in a container and the patient himself chooses the color of his choice. They enter one of the two experimental and control groups.
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 Qazvin University of Medical Sciences
Street address
Unit 1, 10 floor, Kasra tower 5, Nokhbegan square
City
Qazvin
Province
Qazvin
Postal code
3415866563
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.QUMS.REC.1401.239
Health conditions studied
1
Description of health condition studied
Hemodynamic changes
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Bleeding rate
ICD-10 code
ICD-10 code description
3
Description of health condition studied
arrhythmia
ICD-10 code
I49.9
ICD-10 code description
Cardiac arrhythmia, unspecified
Primary outcomes
1
Description
Bleeding
Timepoint
First, three minutes after the start of induction, then three and five minutes and then ten minutes
Intervention group 1: Patients who met the necessary conditions, after full training by an anesthesiologist and filling in the patient's informed personal consent form, entered the study and were randomly assigned to experimental group A (remifentanil combined with propofol). Dose of drugs: Remifentanil: the onset of anesthesia starts with 1 to 5 mcg/kg/minute. If an endotracheal tube is inserted for the patient within 8 minutes, an initial dose of 1 mcg/kg in 30-60 Seconds are also given to maintain anesthesia: 1 mcg/kg/min can be infused every 2-5 minutes. The dose can be increased by 25-100% or decreased by 25-50% every 2-5 minutes. Propofol: within 15 seconds and with a dose of 2 mg/kg based on the weight of the study group, it is injected through a tee along with 10 cc of normal saline.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients who met the necessary conditions, after full training by the anesthesiologist and filling out the patient's informed personal consent form, entered the study and were randomly assigned to experimental group B (labtalol in combination with propofol). Dosage of drugs: labtalol: 20 mg intravenous injection once and then, if there is no effect, as an infusion of 2-0.5 mg per minute up to a maximum dose of 300 mg and propofol: within 15 seconds and with a dose of 2 mg/kg based on The weight of the study group is injected with 10 cc of normal saline through a tee
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Khashayar Shahverdi
Street address
Quds Educational and Medical Center, Quds Square, the beginning of East Palestine, Shahid Beheshti Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
kh.shahverdi@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashmi
Street address
Research and Technology Vice-Chancellor of Qazvin University of Medical Sciences, Mavedat sub-district, Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Khashayar Shahverdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 1, Floor 10, Kasra 5, Nokhbegan square
City
Qazvin
Province
Qazvin
Postal code
3415866563
Phone
+98 21 2270 7778
Fax
Email
kh.shahverdi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Khashayar Shahverdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 1, Floor 10, Kasra 5, Nokhbegan square
City
Qazvin
Province
Qazvin
Postal code
3415866563
Phone
+98 21 2270 7778
Fax
Email
kh.shahverdi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Khashayar Shahverdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 1, Floor 10, Kasra 5, Nokhbegan square
City
Qazvin
Province
Qazvin
Postal code
3415866563
Phone
+98 21 2270 7778
Fax
Email
kh.shahverdi@qums.ac.ir
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