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Comparison of the effect of norogol (Valerian and lemon balm) and clonidine onanxiety, hemodynamic changes and shivering in total knee replacement subjects.

Protocol summary

Study aim
Determining the comparison of the effects of Neurogol (Valerine and Lemon Balm) and Clonidine on anxiety, hemodynamic changes and shivering in total knee replacement
Design
A clinical trial with a control group (oral tablets containing Neurogol, clonidine tablets), standard treatment control group (without drugs) with parallel groups, randomized, phase 3 on 96 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The place of study is Imam Khomeini Hospital, Sari. Sampling using closed envelope method and random numbers table will place patients in three control and control groups. Two nights before the surgery, after completing the questionnaire, two tablets of Neurogol were given to the intervention group and the control group was given no medication. Clonidine along with the placebo was given to the patient on the morning of the surgery 1 to 1 and a half hours before the surgery.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study include full consciousness of the patient, class 1 and 2 of the American Society of Anesthesiology, minimum literacy and reading and writing, no consumption of alcohol and anti-anxiety and sedative drugs, no history of mental-neurological disease.Exclusion criteria are people with severe anxiety (overt anxiety score higher than 64 or hidden anxiety score higher than 62), history of allergy to clonidine and Neurogol drugs, use of tourniquet, users of sedative or anti-anxiety drugs, underlying disease or pregnancy.
Intervention groups
The intervention groups will be assigned to three groups of oral tablets containing Neurogol (N), clonidine tablets (K) as the control group and the standard treatment group (without medicine) as the control group.
Main outcome variables
anxiety

General information

Reason for update
Acronym
TKA
IRCT registration information
IRCT registration number: IRCT20230226057544N1
Registration date: 2023-05-07, 1402/02/17
Registration timing: registered_while_recruiting

Last update: 2023-05-07, 1402/02/17
Update count: 0
Registration date
2023-05-07, 1402/02/17
Registrant information
Name
Fatemeh Hasanzadeh sablouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3343 2518
Email address
f.hasanzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-20, 1402/01/31
Expected recruitment end date
2023-06-19, 1402/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of norogol (Valerian and lemon balm) and clonidine onanxiety, hemodynamic changes and shivering in total knee replacement subjects.
Public title
Comparison of the norogol (Valerian and lemon balm) and clonidine onanxiety, hemodynamic changes and shivering in total knee replacement subjects.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness of the patient Class 1 and 2 of the American Society of Anesthesiology Minimum literacy and reading and writing Not using alcohol and anti-anxiety and sedative drugs No history of mental illness
Exclusion criteria:
People with severe anxiety (overt anxiety score higher than 64 or hidden anxiety score higher than 62) History of allergy to Clonidine and Neurogel drugs Using a tourniquet Users of sedative or anti-anxiety drugs Underlying disease pregnancy
Age
From 35 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
This research will be assigned to three groups of oral tablets containing Neurogol (N), clonidine tablets (K) as a control group and standard treatment without medication as a control group before starting the study by block randomization method. The blocks of this research are 8 (NN, KK, CC) and 12 states will be created. First, the possible states of these 8 letters in the blocks are specified and then randomly and using the table of random numbers of the block numbers. It will be clear that in this way, the type of intervention will be determined based on the desired letters with the patient's capsule number and will be kept in a master sheet, and finally, the intervention number of each patient will be inserted on a sheet and the type of intervention will be known at that moment.The continuous entry number of the patients is written on the envelope, and the type of intervention or control is specified inside the envelope. Gradually, according to the presence of eligible patients, the relevant envelope will be returned and the type of intervention inside the non-transparent envelope will be determined. The randomization unit is individual.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, 3rd floor, building number 2 of Mazandaran University of Medical Sciences,building number 2 of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.MAZUMS.REC.1402.039

Health conditions studied

1

Description of health condition studied
Anxiety in total knee joint replacement
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Hidden anxiety score in Spielberger questionnaire
Timepoint
The amount of overt and hidden anxiety will be measured with the Spielberger questionnaire two nights before the surgery and before receiving the drugs and one hour before the surgery.
Method of measurement
How to measure hidden anxiety variable is "Spielberger Questionnaire".

2

Description
Overt anxiety score in Spielberger questionnaire
Timepoint
The level of obvious anxiety will be measured with the Spielberger questionnaire two nights before the surgery and before receiving the drugs and one hour before the surgery.
Method of measurement
The way to measure the obvious anxiety variable is the Spielberger Questionnaire.

Secondary outcomes

1

Description
Associated shivering score
Timepoint
To determine the condition after surgery, it will be measured every 10 minutes (0, 10, 20, 30, 40, 50 and 60 minutes) by observing the patient during recovery.
Method of measurement
The way to measure the secondary variable of shivering is "Crossley Mahajan Questionnaire".

2

Description
Systolic blood pressure
Timepoint
It will be recorded by monitoring in three time periods before cutting, during cutting every 5 minutes in the first 15 minutes after cutting and after closing the skin and the end of the surgery, and then every 15 to 120 minutes during the recovery time until the end of the surgery.
Method of measurement
monitoring

3

Description
diastolic blood pressure
Timepoint
It will be recorded by monitoring in three time periods before cutting, during cutting every 5 minutes in the first 15 minutes after cutting and after closing the skin and the end of the surgery, and then every 15 to 120 minutes during the recovery time until the end of the surgery.
Method of measurement
monitoring

4

Description
heart beat
Timepoint
It will be recorded by monitoring in three time periods before cutting, during cutting every 5 minutes in the first 15 minutes after cutting and after closing the skin and the end of the surgery, and then every 15 to 120 minutes during the recovery time until the end of the surgery.
Method of measurement
monitoring

5

Description
Blood oxygen saturation
Timepoint
It will be recorded by monitoring in three time periods before cutting, during cutting every 5 minutes in the first 15 minutes after cutting and after closing the skin and the end of the surgery, and then every 15 to 120 minutes during the recovery time until the end of the surgery.
Method of measurement
monitoring

Intervention groups

1

Description
Patients will be divided into three groups of oral tablets containing Neurogol and clonidine tablets (intervention group), standard treatment group and no medication (control group). Two nights before the surgery, after completing the questionnaire (including demographic information, disease information, vital signs and Spielberger questionnaire), two pills in the intervention group (Nurogol, a product of Gol Daru Company) along with 50cc of water will be given to the patients. And lemon balm can be prepared as a standard product in the pharmaceutical market of Iran under the brand name Norogol.Each tablet contains 160 mg of dry extract of valerian root and 80 mg of dry extract of lemon balm leaf. Due to the long effect of clonidine, the medicine is given to the patient on the morning of the operation 1 to 1 and a half hours before the surgery, and the questionnaire before and after Clonidine is rapidly absorbed after oral administration and its concentration reaches its maximum in 1.5 to 2 hours. Its half-life is about 8-12 hours. In the standard treatment group, the variables will be measured two nights before, before, during and after the operation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam khomeini hospital
Full name of responsible person
Pedram Ebrahimnejad
Street address
Imam Khomeini Educational and Medical Center, Razi St
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
pebrahimnejad@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice-Chancellor.3rd floor, Building No. 2 of Mazandaran University of Medical Sciences and Health Care Services, Research and Technology, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim nasiri formi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty paramedicine, payambar azam copmlex, 18 KM Farahabad
City
Sari
Province
Mazandaran
Postal code
48471-16548
Phone
+98 911 151 7836
Email
enasiri@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim nasiri formi
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty paramedicine,Payambar azam complex,18 KM farahabad
City
Sari
Province
Mazandaran
Postal code
48471-16548
Phone
+98 11 3354 3247
Email
enasiri@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim nasiri formi
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
faculty in paramedicine,payambar azam complex,18 KM farahabad
City
Sari
Province
Mazandaran
Postal code
48471-16548
Phone
0098113354324+
Fax
Email
Enasiri@mazums.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
Name the information in the checklist and consent
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions, people working in the industry
Under which criteria data/document could be used
The use of data for the purpose of drawing conclusions or designing similar studies or systematic studies as well as use in the pharmaceutical industry is allowed.
From where data/document is obtainable
Dr. Ebrahim Nasiri with email address: enasiri@mazums.ac.ir
What processes are involved for a request to access data/document
One day to one month
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