1. Home
  2. Approved trials
  3. » فارسی

Comparison the effects of Dexmedetomidine and Labetalol for induced hypotension in maxillofacial fractures surgery

Protocol summary

Study aim
Comparison the effects of dexmedetomidine and Labetalol for induced hypotension in maxillofacial fractures surgery
Design
Patients in the first group receive dexmedetomidine with bolus infusion of 1 µg / kg / h and maintenance dose of 3.0 -5.0 µg/kg/h and in the second group receive infusion of labetalol with bolus dose of 0.3 mg/kg/h and maintenance dose of 0.2-0.5 mg/kg/h .
Settings and conduct
The place of study is operation room of Shahid Rajaee Hospital in Qazvin. 0.02 mg/kg of midazolam and 1.5 mg/kg of fentanyl will be used for sedation, 5 mg/kg of lidocaine and 2 mg/kg of propofol will be used for induction of anesthesia and 0.5 mg/kg of atracurium were used as muscle relaxants. Following surgery and stabilization of the patient's hemodynamic status and due to the color of the cards, dexmedetomedine was used in one group and labetalol in the other group. Patient, surgeon, outcome assessor, and statistician were unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria are age 18 to 60 years, ASA class 1 and 2 and fracture of mandible or maxilla. Exclusion criteria are ASA 3 and more, heart block, heart failure, unstable hemodynamics, depression, renal failure, Raynaud's phenomenon, sensitivity to lidocaine or beta-blockers, deformity of trachea and lack of consent to participate in the study.
Intervention groups
In this study, two intervention groups, including the Dexmedetomidine and the Labetalol treatment groups, will be used to induce hypotension in surgery.
Main outcome variables
Systolic blood pressure, diastolic blood pressure, mean arterial pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170408033291N3
Registration date: 2019-12-30, 1398/10/09
Registration timing: retrospective

Last update: 2019-12-30, 1398/10/09
Update count: 0
Registration date
2019-12-30, 1398/10/09
Registrant information
Name
Ali Alizadeh
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 0105
Email address
a.alizadeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison the effects of Dexmedetomidine and Labetalol for induced hypotension in maxillofacial fractures surgery
Public title
Comparison the effects of Dexmedetomidine and Labetalol on blood pressure in maxillofacial fractures surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 60 years Class 1 & 2 of American Anesthesiologists (ASA) Association Classification Fracture of mandible or maxilla
Exclusion criteria:
Class 3 or more of American Anesthesiologists (ASA) Association Classification Heart Block Heart Failure Unstable Hemodynamic Depression Renal Failure Raynaud's phenomenon Sensitivity to lidocaine or beta-blockers Deformity of Trachea Lack of consent to participate in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Equal numbers of red and green cards representing the two groups under study are placed in a container and the patient selects a card from the container before entering the operating room. The type of intervention is determined by the color of the card selected. The patient, clinical caregiver, outcome assessor, and statistician were unaware of the study codes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2018-12-13, 1397/09/22
Ethics committee reference number
IR.QUMS.REC.1397.236

Health conditions studied

1

Description of health condition studied
Fracture of mandible
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before surgery, after intubation, after induction of hypotension, after bolus dose, 3, 5, 10, 15, 30, 60 min after bolus dose, end of operation and recovery.
Method of measurement
Using a blood pressure monitor device

2

Description
Diastolic blood pressure
Timepoint
Before surgery, after intubation, after induction of hypotension, after bolus dose, 3, 5, 10, 15, 30, 60 min after bolus dose, end of operation and recovery.
Method of measurement
Using a blood pressure monitor device

3

Description
Mean arterial blood pressure
Timepoint
Before surgery, after intubation, after induction of hypotension, after bolus dose, 3, 5, 10, 15, 30, 60 min after bolus dose, end of operation and recovery.
Method of measurement
Using a blood pressure monitor device

Secondary outcomes

1

Description
Heart Rate
Timepoint
Before surgery, after intubation, after induction of hypotension, after bolus dose, 3, 5, 10, 15, 30, 60 min after bolus dose, end of operation and recovery.
Method of measurement
Using cardiac monitoring device

Intervention groups

1

Description
First intervention group: Patients in the first group receive dexmedetomidine with bolus infusion of 1µg/kg/h and maintenance dose of 3.0 -5.0 µg/kg/h
Category
Treatment - Drugs

2

Description
Second intervention group: Patients in the second group receive infusion of labetalol with bolus dose of 0.3 mg/kg/h and maintenance dose of 0.2-0.5 mg/kg/h .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin Shahid Rajaee Hospital
Full name of responsible person
Ali Alizadeh
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
a.alizadeh@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
a.alizadeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Aydin Binazadeh
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
binazadehaydin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Alizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
a.alizadeh@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Alizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
a.alizadeh@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after people are unrecognizable.
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
Data will be available only to researchers working in academic and research institutions.
Under which criteria data/document could be used
For further research or meta-analysis
From where data/document is obtainable
Dr. Ali Alizadeh Email Address: a.alizadeh@qums.ac.ir
What processes are involved for a request to access data/document
Permission from Vice-Chancellor for Research and Technology Affairs of Qazvin University of Medical Sciences
Comments
Loading...