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Investigating the effect of Clonidine on the amount of bleeding in patients undergoing Septorhinoplasty surgery

Protocol summary

Study aim
Investigating the effect of clonidine on the amount of bleeding in patients undergoing Septorhinoplasty surgery
Design
A clinical trial with a control group, with parallel groups, double-blind, on 54 patients, Randomized by the method of Balanced Block Randomization
Settings and conduct
This study is conducted on candidates for Septorhinoplasty in Rajaee Hospital in Qazvin. After obtaining informed consent, they are randomly assigned to the experimental group or the control group. Diazepam 0.1 mg/kg orally for both groups and Clonidine 3 mg/kg orally before surgery just for the intervention group. Blood pressure is recorded before anesthesia, after intubation, at the end of surgery, and after transfer to recovery. The bleeding (the number of entirely bloody gases and blood in the suction device), Heart rate, and breathing rhythm information are entered in the form. The researcher, participant, and clinical supervisor are blinded.
Participants/Inclusion and exclusion criteria
Entry conditions: Informed consent; Candidate for Septorhinoplasty; age range from 20 to 45; Physical class above 2 Non-entry conditions: Lung disease, diabetes, coagulation disorders, ischemic heart disease; history of rhinoplasty surgery; history of smoking, alcohol, and drugs; chronic mental and physical illness; vision and hearing problems and other disabilities; Use of corticosteroids, antihistamines, painkillers، beta-blockers or calcium channel blockers; Patients with systolic blood pressure less than 100 mm Hg or heart rate less than 40 per minute; patients with the prohibition of anesthesia; Pregnancy, breastfeeding, and abortion less than 3 months
Intervention groups
Diazepam 0.1 mg per kilogram orally for both groups and Clonidine 3 micrograms per kilogram orally 90 minutes before surgery just for the intervention group is prescribed by an anesthesiologist
Main outcome variables
Blood pressure; Bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230715058778N1
Registration date: 2023-07-23, 1402/05/01
Registration timing: prospective

Last update: 2023-07-23, 1402/05/01
Update count: 0
Registration date
2023-07-23, 1402/05/01
Registrant information
Name
Mostafa Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3379 0620
Email address
dr.mostafaghasemi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Clonidine on the amount of bleeding in patients undergoing Septorhinoplasty surgery
Public title
Effect of Clonidine on the bleeding of Septorhinoplasty patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for Septorhinoplasty Age range 20-45 Physical class above 2 Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study
Exclusion criteria:
Having any lung disease History of Rhinoplasty surgery History of smoking, alcohol and drugs Chronic mental and physical illness (Schizophrenia, Diabetes, etc.) Vision and hearing problems and other disabilities Long-term use of Corticosteroids, antihistamines, narcotics and painkillers Having diabetes Coagulation disorders Ischemic heart disease History of taking beta blockers or calcium channel blockers patients with systolic blood pressure less than 100 mmHg or heart rate less than 40per minute patients with relative or absolute prohibition of general anesthesia Pregnancy, breast feeding and abortions less than 3 months
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation in this study is Balanced Block Randomization. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator gives the pill in an unspecified package to the patient randomly before induction of anesthesia. The surgeon and the clinical caregiver are blinded, and the patient does not know what drug he used and whether this drug was one of the study drugs or part of the hospital's routine.
Placebo
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
Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2023-07-14, 1402/04/23
Ethics committee reference number
IR.QUMS.REC.1402.099

Health conditions studied

1

Description of health condition studied
Bleeding during Septorhinoplasty surgery
ICD-10 code
Y52.5
ICD-10 code description
Other antihypertensive drugs, not elsewhere classified

Primary outcomes

1

Description
The effect of Clonidine on blood pressure during Septorhinoplasty
Timepoint
Systolic and diastolic blood pressure are measured before induction of anesthesia, after intubation of the patient, at the end of surgery and after transfer to recovery.
Method of measurement
Blood pressure measurement is done by monitoring device and recorded by evaluator

2

Description
The effect of clonidine on the amount of bleeding during Septorhinoplasty
Timepoint
After surgery
Method of measurement
The amount of blood in the suction device and the number of completely blood gases. Before the operation, a strong pharyngeal peg is inserted by the surgeon, and at the end of the operation, after the peg is removed, the blood in the nasopharynx is suctioned and added to the amount of bleeding.

Secondary outcomes

1

Description
Effect of Clonidine on heart rate
Timepoint
Before induction of anesthesia, after patient intubation, at the end of surgery and after transfer to recovery
Method of measurement
Monitoring device

2

Description
breathing rhythm
Timepoint
Before induction of anesthesia, after patient intubation, at the end of surgery and after transfer to recovery
Method of measurement
Monitoring device

Intervention groups

1

Description
Intervention group: Diazepam 0.1 mg per kilogram orally and Clonidine 3 micrograms per kilogram orally 90 minutes before surgery are prescribed by the anesthesiologist in a room with a temperature of 25 degrees Celsius.
Category
Treatment - Drugs

2

Description
Control group: Diazepam 0.1 mg per kilogram is administered orally by an anesthesiologist in a room with a temperature of 25 degrees Celsius.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Mostafa Ghasemi
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
34719 76161
Phone
+98 28 3379 0620
Email
Clinical_research@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mahidi Mirhashemi
Street address
Mavaddat Alley ,Research and Technology deputy, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Mostafa Ghasemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
Dr.mostafaghasemi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mostafa Ghasemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
Dr.mostafaghasemi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mostafa Ghasemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
Dr.mostafaghasemi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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 can be shared after individuals are de-identified
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of analysis on the delivered data is allowed
From where data/document is obtainable
Refer to Dr.Mostafa Ghasemi s Email Dr.mostafaghasemi@yahoo.com
What processes are involved for a request to access data/document
After publishing the article, the applicant can send a clear request to the author to access the data by sending an email. So, after reviewing the request within 2 weeks, access to data and information is allowed.
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