The Efficacy of Tranexamic Acid and the Association of Rate Pressure Product Index on Intraoperative Bleeding during Rhinoplasty.
Design
Double-blind placebo-controlled clinical trial
Settings and conduct
Intervention group: patients received 1gr Tranexamic acid intraoperatively (total volume of 10 cc).
Control group: patients received the same volume of Tranexamic acid (10 cc) of normal saline as placebo intraoperatively in the second group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:18-45 year_ old patients undergoing rhinoplasty surgery.
Exclusion Criteria: patients with systemic disease, history of any drug consumption, hemorrhagic disease, liver dysfunction, renal dysfunction, using anticoagulant drugs, heart block, myocardial ischemia and morbid obesity.
Intervention groups
Intervention group: patients received 1gr Tranexamic acid intraoperatively (total volume of 10 cc).
Control group: patients received the same volume of Tranexamic acid (10 cc) of normal saline as placebo intraoperatively in the second group.
Main outcome variables
Intra and postoperative bleeding,The rate-pressure product (RPP), Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N109
Registration date:2021-02-08, 1399/11/20
Registration timing:prospective
Last update:2021-02-08, 1399/11/20
Update count:0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-17, 1399/11/29
Expected recruitment end date
2021-03-04, 1399/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Tranexamic Acid and the Association of Rate Pressure Product Index on Intraoperative Bleeding during Rhinoplasty.
Public title
The Efficacy of Tranexamic Acid and the Association of Rate Pressure Product Index on Intraoperative Bleeding during Rhinoplasty.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18-45 year_ old
patients undergoing rhinoplasty surgery.
Exclusion criteria:
Patients with systemic disease
History of any drug consumption
Hemorrhagic disease
Liver dysfunction
Renal dysfunction
Using anticoagulant drugs
Heart block
Myocardial ischemia
Morbid obesity
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated randomization table will be used to randomly allocated patients to the intervention and placebo groups based on www.sealedenvelope.com Seed: 258004702634303 block sizes 4,6 and 8.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications were prepared by other nurses who were totally unaware of the nature of the study. While anesthesiologist and surgeon were blinded, Neither the participants nor the investigators involved in data collection and assessing the outcomes are aware of the identity of the target drugs used in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street