1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of tranexamic acid and dexmedetomidine on intra-operative bleeding in patients candidate for rhinoplasty

Protocol summary

Summary
Objectives: The aim of this study is to compare the effect of dexmedetomidine and tranexamic acid on intra-operative bleeding within rhinoplasty surgery. Design: Block randomization, double blind, without placebo, single center, trial phase 2, including 76 patients who are candidate for rhinoplasty surgery. Participants including major eligibility criteria: Patients who are candidate for rhinoplasty surgery. Intervention: Tranexamic acid, 10 mg/kg, immediately after anesthesia induction, intravenously. Dexmedetomidine, 1 µg/kg, immediately after anesthesia induction, intravenously. Main outcome measures: Bleeding volume, Surgeon satisfaction, Surgery duration, Recovery duration.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014122520434N1
Registration date: 2015-07-16, 1394/04/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-16, 1394/04/25
Registrant information
Name
gita fotoohi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
hassani.v@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tranexamic acid and dexmedetomidine on intra-operative bleeding in patients candidate for rhinoplasty
Public title
Comparison of the effect of tranexamic acid and dexmedetomidine on amount of bleeding in cosmetic nose surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient satisfaction; Age between 18-60 years old; ASA class I-II. Exclusion criteria: Patients with liver, kidney, and cardiovascular diseases or diabetes mellitus; Opium addiction; Using benzodiazepines or clonidine; Sensitivity to study drugs; Pregnancy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Researcher and patient are not aware of grouping. Blocked randomization is used in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-08-23, 1393/06/01
Ethics committee reference number
822/105/94د

Health conditions studied

1

Description of health condition studied
Rhinoplasty
ICD-10 code
Y83.4
ICD-10 code description
Other reconstructive surgery

Primary outcomes

1

Description
Surgeon satisfaction
Timepoint
From the onset of surgery to its end
Method of measurement
Based on surgeon opinion as good, moderate, and bad

2

Description
Bleeding volume
Timepoint
From the onset of surgery to its end
Method of measurement
The number of used gases

3

Description
Blood pressure
Timepoint
From the onset of surgery since 180 minutes later, every 30 minutes
Method of measurement
Sphygmometer

Secondary outcomes

1

Description
Surgery duration
Timepoint
From the onset of surgery to its end
Method of measurement
Minute

Intervention groups

1

Description
Intervention group 1: Tranexamic acid, 10 mg/kg, immediately after anesthesia induction, intravenously.
Category
Prevention

2

Description
Intervention group 2: Dexmedetomidine, 1 µg/kg, immediately after anesthesia induction, intravenously.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e Akram hospital
Full name of responsible person
Samira
Street address
Berenjian
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Seyed Mohsen Ziyaeifard
Street address
Headquarters building, 2nd floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Berenjian
Full name of responsible person
Samira
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
S_samira1357@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Berenjian
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
S_samira1357@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Berenjian
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
S_samira1357@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...