Objectives: Comparative study of the dexmedetomidine and magnesium sulphate in controlled hypotension in patients candidate for rhinoplasty operation
Study design: 60 patients candidated for rhinoplasty will be recruited and allocated in two groups: dexmedetomidine and magnesium sulphate. The study is unblinded and allocation is by simple randomization. The study is a phase 1/2 trial and single-center.
Study method: demographic information and their medical history as well as the following items will be recorded and analyzed: surgical field quality in terms of bleeding and visibility by the surgeon according to the Fromme and colleagues grading method, surgeon's satisfication score and postsurgical recovery according to the modified Aldrete grading.
participants: patients candidate for rhinoplasty surgery in Firouzgar hospital provided informed consent will be included in the current study. Patients with revision rhinoplasty, allergy to one of the drugs in this study, drug abuse and coagulation disorders will be excluded from this study.
Interventions: dexmedetomidine and magnesium sulphate as hypotensive agents.
Main outcome measures: surgical field quality in terms of bleeding and visibility by the surgeon according to the Fromme and colleagues grading method, surgeon's satisfication score and postsurgical recovery according to the modified Aldrete grading.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100431487N4
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the dexmedetomidine and magnesium sulphate in controlled hypotension in patients candidate for rhinoplasty operation
Public title
Comparison of the effects of two medications in controlled hypotension in patients under rhinoplasty operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate for rhinoplasty operation; minimum 18 and maximum 50 years of age; ASA grade I; informed consent
Exclusion criteria: revision rhinoplasty; known allergy to drugs being tested; drug abuse; coagulation disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Research Ethics Committee of the Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
15459-13487
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.IUMS.REC1395.138340
Health conditions studied
1
Description of health condition studied
Rhinoplasty surgical operation
ICD-10 code
Z41.1
ICD-10 code description
Other plastic surgery for unacceptable cosmetic appearance
Primary outcomes
1
Description
quality of surgical field in terms of bleeding and visibility by surgeon of the operation field
Timepoint
during operation
Method of measurement
Fromme and colleagues 6-point grading system
2
Description
Surgeon's satisfaction score
Timepoint
At the end of the operation
Method of measurement
4-point surgeons satisfaction grading system
3
Description
post-operative recovery rate
Timepoint
After recovery
Method of measurement
Modified Aldrete’s Scoring System (duration of the time required to achieve score 9)
Secondary outcomes
empty
Intervention groups
1
Description
Magnesium sulphate (50%) with dose of 40 mg/kg administered in 10 minutes before anesthesia induction and continued with 10-15 mg/kg/hr during the anesthesia.
Category
Treatment - Drugs
2
Description
Dexmedetomidine with bolus dose of 0.1 µg/kg dissolved in 50 milliliters of normal saline and injected 10 minutes before anesthesia induction and continued with infusion of 0.4-0.6 µg/kg/hr during anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Dr Soudabeh Djalali
Street address
Behafarin st., Karim Khan Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Office of Vice-chancellor for Research, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Iran University of Medical Sciences