Comparison effect of labetalol and dexmedetomidine for controlled
hypotension in patients with rhinoplasty
Design
The study will be double blind and clinical trial.64 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients candidate for rhinoplasty in Amirkabir Hospital in Arak are divided into 2 groups by simple randomization with block. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age range 18 to 45 years ,body mass index 20 to 30, no history of cardiovascular disease, pulmonary disease, renal disease and hepatic diseases, no history of allergy to labetalol and dexmedetomidine, no pregnancy and lactation, ASA class I and II
Exclusion criteria:For any reason, they have suffered cardiorespiratory arrest during previous surgeries
Intervention groups
The first group of intervention: We will infuse 0.3 milligram in kilogram in hours of labetalol during surgery.
The second group of intervention: We will infuse 0.5 microgeram in kilogram in hours Dexmedetomidine during surgery.
Main outcome variables
Sedation, bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N171
Registration date:2022-01-16, 1400/10/26
Registration timing:registered_while_recruiting
Last update:2022-01-16, 1400/10/26
Update count:0
Registration date
2022-01-16, 1400/10/26
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
2022-01-05, 1400/10/15
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of labetalol and dexmedetomidine in induction of control hypotension in patients with rhinoplasty
Public title
Comparison of the effect of labetalol and dexmedetomidine in induction of control hypotension in patients with rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 45 years
Candidate patients for rhinoplasty surgery
Body mass index 20 to 30
The duration of surgery is between 90 to 150 minutes
No history of cardiovasculsar disease, pulmonary disease, renal disease and hepatic diseases
No history of allergy to labetalol and dexmedetomidine
No pregnancy and lactation
ASA class I and II
Exclusion criteria:
For any reason, they have suffered cardiorespiratory arrest during previous surgeries
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study. Analysts, evaluators, and participants are unaware of the grouping.The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern, and the patients are not aware of their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.ARAKMU.REC.1400.239
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
Recovery
Method of measurement
Ramsay score
2
Description
Bleeding
Timepoint
During operation and recovery
Method of measurement
Observation,The amount of bleeding is reported on millilitre.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We will infuse 0.3 milligram in kilogram in hours of labetalol during surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: We will infuse Dexmedetomidine 0.5 microgeram in kilogram in hours during surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr HAlireza Kamali
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street