The effect of intravenous dexmedetomidine on bleeding rate,surgeon satisfaction and hemodynamic stability in patients undergoing septorhinoplasty surgery
Investigating the effect of intravenous dexmedetomidine on bleeding rate, surgeon satisfaction and hemodynamic stability in patients undergoing septorhinoplasty surgery.
Design
This study will be a randomized double-blind phase three clinical trial with parallel groups on 74 patients referred to Motahari Jahrom Hospital who will undergo septorhinoplasty surgery under general anesthesia. Patients participating in the study will be divided into two groups using a table of random numbers.
Settings and conduct
Patients referred to Jahrom Motahari Hospital who undergo septorhinoplasty surgery with general anesthesia will be included in the study. The patients participating in the study will be divided into two groups using a table of random numbers. The person participating in the study, the researcher and the person collecting the data will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Jahrom Motahari Hospital who underwent septorhinoplasty surgery with general anesthesia and expressed their consent to participate in the study.
Exclusion criteria include patients who do not have hemodynamic stability and have used anticoagulant drugs.
Intervention groups
Intervention group 1: dexmedetomidine (manufactured by Razi Company, 1 mcg/kg per ten minutes along with routine anesthesia and maintenance drugs: 6/. mcg/kg per hour).
Intervention group 2: will receive placebo as the control group.
The effect of intravenous dexmedetomidine on bleeding rate,surgeon satisfaction and hemodynamic stability in patients undergoing septorhinoplasty surgery
Public title
The effect of intravenous dexmedetomidine on bleeding rate,surgeon satisfaction and hemodynamic stability in patients undergoing septorhinoplasty surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Physical status of ASA class I, II
Filling out the consent form to participate in the study
Exclusion criteria:
Unstable hemodynamics at the moment of entering the operating room (systolic pressure less than 90, diastole less than 60 and heart rate less than 60)
Taking drugs affecting hemodynamic status
Taking anticoagulants drugs
Age
From 15 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be an easy and accessible sampling of patients undergoing septorhinoplasty surgery during the study period, but the random division of people into two groups (RANDOM ALLOCATION) will be based on a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the patient will be unaware of the type of injectable drug and only the anesthesiologist who gives the drug to the specialist will be aware of the type of injected drug. Also, injection syringes were labeled so that the type of drug is not known.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahari Street
City
Jahrom
Province
Fars
Postal code
7164852514
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.JUMS.REC.1401.105
Health conditions studied
1
Description of health condition studied
Cosmetic Surgery
ICD-10 code
Z41.1
ICD-10 code description
Encounter for cosmetic surgery
Primary outcomes
1
Description
Hemodynamic symptoms
Timepoint
Before induction, after induction, 1 minute after induction, 5 minutes after induction, 30, 60, 90 and 120 minutes during operation, entering recovery and exiting recovery.
Method of measurement
Monitoring
2
Description
Consent of the surgeon
Timepoint
During operation every 15 minutes after the start of surgery
Method of measurement
Beozaart scale
3
Description
Bleeding
Timepoint
During surgery and at the end of the operation
Method of measurement
The amount of blood collected in suction and surgical gases
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: dexmedetomidine (manufactured by Razi Company, 1 mcg/kg per ten minutes along with routine anesthesia and maintenance drugs: 6/. mcg/kg per hour).
Category
Treatment - Drugs
2
Description
Intervention group 2: will receive placebo as the control group.The placebo includes an equal volume of normal saline injection similar to the intervention group.