Protocol summary

Study aim
Comparison of four drugs clonidine, bisoprolol, tranexamic acid and gabapentin on bleeding rate, hemodynamic stability and intraoperative surgeon satisfaction
Design
This study will be a double-blind randomized clinical trial with parallel groups on 75 patients referred to Motahhari Hospital in Jahrom who undergo rhinoplasty surgery. In this study, computerized block randomization (13 blocks of 10) will be performed. An independent epidemiologist who is not involved in the study will use a random blockchain program (SATA14) to generate allocation codes. Random sequences will be placed in light-resistant and sealed envelopes. The research assistant will open sealed, numbered, and opaque envelopes containing the assignment codes.
Settings and conduct
Patients referred to Motahari Hospital in Jahrom who will undergo rhinoplasty surgery will be included in the study. Patients participating in the study will be divided into five groups by throwing dice: clonidine, bisoprolol, gabapentin, tranexamic acid and control. The person participating in the study, the researcher and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Motahhari Hospital in Jahrom who underwent rhinoplasty and expressed their consent to participate in the study. Exclusion criteria : includes patients who do not have hemodynamic stability.
Intervention groups
Intervention group 1: They will receive clonidine / 2 mg intravenously. Intervention group 2: They will receive 5.2 mg bisoprolol tablets. Intervention group 3:They will receive 4 capsules gabapentin 300 mg . The intervention group 4:They will receive 4 capsules of 250 mg tranexamic acid. Intervention group 5: They will receive a placebo as a control group.
Main outcome variables
Bleeding, hemodynamic stability and surgical surgeon satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210415050976N11
Registration date: 2022-05-05, 1401/02/15
Registration timing: prospective

Last update: 2022-05-05, 1401/02/15
Update count: 0
Registration date
2022-05-05, 1401/02/15
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of four drugs clonidine, bisoprolol, tranexamic acid and gabapentin on bleeding rate, hemodynamic stability and intraoperative surgeon satisfaction in patients undergoing rhinoplasty surgery.
Public title
Comparison of four drugs clonidine, bisoprolol, tranexamic acid and gabapentin on bleeding rate, hemodynamic stability and intraoperative surgeon satisfaction in patients undergoing rhinoplasty surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemoglobin above 10 Lack of sensitivity to the drugs used
Exclusion criteria:
Patients with coagulation disorders Blood pressure Coronary artery disease
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, computerized block randomization (13 blocks of 10) will be performed. An independent epidemiologist who is not involved in the study will use a random blockchain program (SATA 14) to generate allocation codes. Eligible participants, after signing the informed consent form, will be divided into five equal groups: clonidine, bisoprolol, gabapentin, tranexamic acid and placebo. Random sequences will be placed in light-resistant and sealed envelopes. The research assistant will open sealed, numbered, and opaque envelopes containing the assignment codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used, so that 1- the person who reviews the results and 2- the person who performs the injections do not know which patient has received clonidine, bisoprolol, gabapentin, tranxamic acid and Placebo only.The drugs Clonidine, bisoprolol, gabapentin, tranexamic acid, and placebo will be packaged in identical glass( two groups of clonidine and bisoprolol, which are in the form of tablets, are powdered and then placed in capsules. The capsules will be the same in all 5 groups) and given to the prescriber, and will be placed in the drug or placebo group, according to a random list, and the glass will be marked A, B, C, D, E will be given to the patient and the patient will be unaware of the type of medicine used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Shiraz
Province
Fars
Postal code
7167758256
Approval date
2022-01-11, 1400/10/21
Ethics committee reference number
IR.JUMS.REC.1400.072

Health conditions studied

1

Description of health condition studied
Rhinoplasty surgery
ICD-10 code
Rhinoplast
ICD-10 code description
Rhinoplasty surgery

Primary outcomes

1

Description
Blood preasure
Timepoint
Before induction، after induction، 1 minute after induction،5 minutes after induction، 30، 60، 90 and 120 minutes during operation، enter recovery and exit recovery
Method of measurement
Monitoring

2

Description
Surgeon Satisfaction
Timepoint
During the operation every 15 minutes after the start of surgery and at the end of the operation
Method of measurement
Beozaart Scale

3

Description
Bleeding
Timepoint
During the operation
Method of measurement
The amount of bleeding in the suction in milliliters

Secondary outcomes

1

Description
Relaxation
Timepoint
In recovery
Method of measurement
Ramsey sedation criteria

Intervention groups

1

Description
Intervention group 1: They will receive clonidine 0/2 mg intravenously.
Category
Treatment - Drugs

2

Description
Intervention group 2: They will receive 5.2 mg bisoprolol tablets.
Category
Treatment - Drugs

3

Description
Intervention group 3: They will receive 4 capsules of gabapentin 300 mg .
Category
Treatment - Drugs

4

Description
Intervention group 4: They will receive 4 capsules of 250 mg tranexamic acid.
Category
Treatment - Drugs

5

Description
Control group: Placebo will normally receive intravenous saline.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Hospital of Jahrom city
Full name of responsible person
Navid Kalani
Street address
Jahrom, Shahid Motahari Boulevard, Motahari Hospital
City
Jahrom
Province
Fars
Postal code
71677251542
Phone
+98 71 3525 5652
Email
Navidkalani@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Solh Joo Kavous
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
navidkalani@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Blvd., University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
71542585125
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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