Protocol summary

Study aim
Determining the effect of dexmedetomidine and labetolol on the amount of bleeding and transparency of the operation field during rhinoplasty surgery
Design
A parallel-group, single-blind, randomized, phase 3 clinical trial on 40 patients. A lottery will be used for randomization.
Settings and conduct
All people aged 17-40 years who underwent primary rhinoplasty surgery in Moradi Rafsanjan Hospital in 1401 will be included in the study. Subjects are randomly assigned to two groups a) Dexmedetomidine b) Labtolol. Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, before induction of anesthesia and 20 minutes after induction of anesthesia (before the start of stoma) and during the stoma stage will be measured using a sphygmomanometer and pulse oximeter and will be entered in the study checklist.
Participants/Inclusion and exclusion criteria
Consent to participate in the study, age 17-40 years, being in anesthesia class I (patients with normal health who do not have any systemic problems such as cardiac, vascular, respiratory, or endocrine problems), no history of known heart disease
Intervention groups
Intervention group 1: They will receive dexmedetomidine at the rate of half to one microgram per kilogram of weight in the form of infusion at the same time as the operation begins. Intervention group 2: They will receive Labetolol in bolus injection form in the required amount (5-20 mg) intravenously during surgery.
Main outcome variables
Systolic blood pressure, diastolic blood pressure, heart rate, blood gas number, bleeding rate, blood weight removed from bleeding, satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150317021497N7
Registration date: 2022-07-16, 1401/04/25
Registration timing: prospective

Last update: 2022-07-16, 1401/04/25
Update count: 0
Registration date
2022-07-16, 1401/04/25
Registrant information
Name
Mohammadreza Mokhtaree
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34260081
Email address
mrmokhtaree@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of Dexmedetomidine and Labetalol on Intraoperative blood loss and surgical field quality in Rhinoplasty: A double-Blinded Clinical Trial
Public title
Comparing effect of Dexmedetomidine and Labetalol on Intraoperative blood loss in Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All subjects undergoing rhinoplasty surgery since the beginning of the study for 6 months 17-40 years
Exclusion criteria:
Drug sensitivity to Dexmedetomidine and labetalol People with systolic blood pressure of 90 mmHg and lower People with a heart rate of less than 60 beats per minute upon entering the operating room
Age
From 17 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the operating room, people will be placed in study groups by lottery. Numbers 1 and 2 are written on a piece of paper and placed in sealed envelopes. The first patient will open the first envelope. If the number 1 comes out of the envelope, it is placed in the dexmedetomidine group, and of course the second person is placed in the labetalol group, and if the number 2 comes out, it is placed in the labetalol group, and the next person is placed in the dexmedetomidine group, and this process will continue until the end of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the project partner who evaluates the hemodynamic indicators does not know about the grouping of people. Also, the data analyst does not know about the grouping of people and the data will be provided to him as a number.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.RUMS.REC.1401.047

Health conditions studied

1

Description of health condition studied
Systolic blood pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension

2

Description of health condition studied
Diastolic blood pressure
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Heart rate per minute
ICD-10 code
R00.8
ICD-10 code description
Other abnormalities of heart beat

4

Description of health condition studied
Mean arterial pressure
ICD-10 code
ICD-10 code description

5

Description of health condition studied
Bleeding rate
ICD-10 code
T81.2
ICD-10 code description
Accidental puncture and laceration during a procedure, not elsewhere classified

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before the start of surgery, after intubation, 20 minutes after intubation, during osteotomy, at the end of surgery, in recovery,
Method of measurement
Mercury sphygmomanometer

2

Description
Diastolic blood pressure
Timepoint
Before the start of surgery, after intubation, 20 minutes after intubation, during osteotomy, at the end of surgery, in recovery
Method of measurement
Mercury sphygmomanometer

3

Description
Heart rate
Timepoint
Before the start of surgery, after intubation, 20 minutes after intubation, during osteotomy, at the end of surgery, in recovery
Method of measurement
Pulse oximeter

4

Description
Bleeding rate
Timepoint
During osteotomy, at the end of surgery
Method of measurement
The difference in the weight of the consumed substances will be used to check the amount of bleeding. (weight of sterile gases after use + weight of suctioned liquids during surgery) - (weight of dry gases before use + amount of normal saline serum for washing the surgical site)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dexmedetomidine in the form of a vial of 200 micrograms in 2 cc has a sympatholytic effect and is used as an infusion at a dose of 1 microgram per kilogram of body weight in 100 cc of normal saline to induce controlled hypotension during anesthesia according to the patient's needs.
Category
Treatment - Drugs

2

Description
Intervention group:Labetalol vial 20 cc contains 5 mg in each cc and is an alpha and beta adrenergic blocker and causes blood pressure reduction with the mechanism of reducing peripheral vascular resistance while preventing the reflex increase of heart rate. It is a fast-acting drug that reaches its peak effect within 5 minutes. It is used in divided doses of 5 mg/cc, maximum 20 mg during anesthesia for one and a half to two hours according to the patient's needs for controlled hypotension.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Moradi hospital
Full name of responsible person
Fatemeh Jadidi
Street address
Shohada
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
fa.jadidi.2020@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinezhad
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Jadidi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
fa.jadidi.2020@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Jadidi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
fa.jadidi.2020@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Jadidi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
fa.jadidi.2020@gmail.com

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 de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Commitment to the principle of fiduciary
From where data/document is obtainable
Sending an official letter to the Research Vice-Chancellor of Rafsanjan University of Medical Sciences
What processes are involved for a request to access data/document
After the approval of the research vice-chancellor of Rafsanjan University of Medical Sciences, the data will be provided to the applicant.
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