Comparison of the efficacy and safety of administering of Tranexamic acid and Dexmedetomidine and Nitroglycerine in preventing bleeding and the quality of the surgical site during septorhinoplasty under general anesthesia
Comparison of the efficacy and safety of administering of Tranexamic acid and Dexmedetomidine and Nitroglycerine in preventing bleeding and the quality of the surgical site during septorhinoplasty under general anesthesia
Design
This study is clinical trial and double blind.105 patients candidate septorhinoplasty surgery in Amirkabir hospital will enter this study.We divide patients in 3 groups by simple randomization.Groups are parallel.
Settings and conduct
105 patients candidate septorhinoplasty surgery in Amirkabir hospital enter this study.This study is double blind. Outcome assessor and analyzer and participant do not know from grouping.Codes of group are available to analyzer and outcome assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 to 60 years , suitable control for blood pressure, no addiction to opioids, , body mass index less than 35
Exclusion criteria:Not having satisfaction to perform surgery ,sensitivity to the drugs studied, need for prescribing antihypertensive medications, in addition to those used in each group ,coagulation disorders,history of cardiovascular disease, pregnancy, chronic pulmonary disease(Asthma)
Intervention groups
First group: 1 micro gram per kilogram Dexmedetomidine during 15 minutes intravenously.
Second group: 10 milligram per kilogram Tranexamic acid during 15 minutes intravenously.
Third group: 0.5 micro gram per kilogram Nitroglycerine during 15 minutes intravenously.
Main outcome variables
blood pressure; heart rate; oxygen saturation; recovery time; duration of surgery; amount of Propofol consumed; amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N121
Registration date:2019-09-24, 1398/07/02
Registration timing:registered_while_recruiting
Last update:2019-09-24, 1398/07/02
Update count:0
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of administering of Tranexamic acid and Dexmedetomidine and Nitroglycerine in preventing bleeding and the quality of the surgical site during septorhinoplasty under general anesthesia
Public title
Comparison of the efficacy and safety of administering of Tranexamic acid and Dexmedetomidine and Nitroglycerine in preventing bleeding and the quality of the surgical site during septorhinoplasty under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years
Suitable control for blood pressure
No addiction to opioids
Body mass index less than 35
Exclusion criteria:
Not having satisfaction to perform surgery
Sensitivity to the drugs studied
Need for prescribing low blood pressure drugs, in addition to those used in each group
Coagulation disorders
History of cardiovascular disease
Pregnancy
Chronic pulmonary disease(Asthma)
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in three groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group 1 and the same number of cards for intervention group 2 and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Groups A and B and C are available to analyzer and outcome assessor and participant .
The drugs are prepared by the anesthesiologist and will be delivered to the student.That he is not aware of the grouping.The intern evaluates the study's implications.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences