76 patients who are candidates for surgery in hospitals affiliated with Islamic Azad University of Tehran are randomly divided into two groups. One hour before surgery, Mirtazapine will be given to the intervention group and placebo to the control group. After transferring the patients to the ward, the pain level of the patients is measured serially. We want to evaluate the preoperative effect of Mirtazapine administration on reducing postoperative pain (pain severity and duration of pain relief).
In this study, we are going to evaluate the preoperative effect of Mirtazapine administration on reducing postoperative pain, in hospitals affiliated with Islamic Azad University of Tehran.
Design
A controlled, single-arm, single-blind, phase 3 clinical trial on 76 patients.
Convenience sampling method was used for sampling.
Settings and conduct
During this single-blind clinical trial study, 76 patients are selected from the patients who are candidates for surgery in the hospitals of Islamic Azad University of Tehran who met the criteria for entering the study, based on the convenience sampling method. After obtaining informed consent, the participants are blinded to study groups.
Patients are randomly divided into two groups receiving Mirtazapine and the control group (placebo B-Complex). One hour before the surgery, the first group will be given a 30mg Mirtazapine tablet orally, and the second group will be given a placebo tablet by student under the supervision of an anesthesiologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who are candidates for surgery
Insensitivity to Mirtazapine
Age between 25 and 50 years
BMI between 20 and 25
ASA one or two
Patient consent to conduct a clinical trial
Criteria for not entering the study:
Surgeries greater than an hour
Emergency surgeries
Pregnant women or the possibility of pregnancy
Diabetic, cardiac, pulmonary and neurological patients
Drug addiction
Intervention groups
Intervention group: Mirtazapine
Control group: B-complex
Main outcome variables
Pain severity is measured serially 2, 6 and 12 hours after leaving the operating room.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221015056178N1
Registration date:2023-08-08, 1402/05/17
Registration timing:prospective
Last update:2023-08-08, 1402/05/17
Update count:0
Registration date
2023-08-08, 1402/05/17
Registrant information
Name
Mobina Niazi Nasihati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 8901
Email address
niazi.mobina@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-12, 1402/05/21
Expected recruitment end date
2023-09-12, 1402/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
76 patients who are candidates for surgery in hospitals affiliated with Islamic Azad University of Tehran are randomly divided into two groups. One hour before surgery, Mirtazapine will be given to the intervention group and placebo to the control group. After transferring the patients to the ward, the pain level of the patients is measured serially. We want to evaluate the preoperative effect of Mirtazapine administration on reducing postoperative pain (pain severity and duration of pain relief).
Public title
Evaluation of the preoperative effect of Mirtazapine administration on reducing postoperative pain, in hospitals affiliated with Islamic Azad University of Tehran in 2023
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for surgery
Insensitivity to Mirtazapine
Age between 25 and 50 years
BMI between 20 and 25
ASA one or two
Patient consent to conduct a clinical trial
Exclusion criteria:
Surgeries greater than an hour
Emergency surgeries
Pregnant women or the possibility of pregnancy
Diabetic, cardiac, pulmonary and neurological patients
Drug addiction
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention group receives mirtazapine with the aim of reducing pain after surgery, while the control group with the same goal is prescribed placebo under the name of B-complex. In this one-sided blind study, the researcher is aware of the recipients of mirtazapine and placebo, but the participants have been blinded to the study groups after obtaining informed consent. The members of the intervention and control groups were randomly selected and there are no special conditions for the classification of patients in this study. The purpose of blinding this clinical trial to the patients receiving the drugs is to investigate the analgesic effects of mirtazapine as best and accurately as possible and to avoid the involvement of confounding factors that affect the results of this study.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Tehran Islamic Azad University of Medical Sciences, Khaqani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.IAU.TMU.REC.1401.069
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of postoperative pain
Timepoint
2, 6 and 12 hours after leaving the operating room
Method of measurement
Visual Analogue Scale (facial experience)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mirtazapine
Category
Prevention
2
Description
Control group: B-Complex
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali hospital
Full name of responsible person
Alireza Teymuri
Street address
Booali hospital, Damavand St., Imam Hosein Square
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Gholamzad
Street address
Tehran Islamic Azad University of Medical Sciences, Khaqani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mgholamzad@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mobina Niazi Nasihati
Position
Medical student/ internship
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 4, Ghazizadeh Alley, Araqi St. , 2nd Bustan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1664913670
Phone
+98 21 2230 8901
Fax
Email
Niazi.mobina@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina Niazi Nasihati
Position
Medical student/ internship
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 4, Ghazizadeh Alley, Araqi St. , 2nd Bustan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1664913670
Phone
+98 21 2230 8901
Fax
Email
Niazi.mobina@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina Niazi Nasihati
Position
Medical student/ internship
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 4, Ghazizadeh Alley, Araqi St. , 2nd Bustan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1664913670
Phone
+98 21 2230 8901
Fax
Email
Niazi.mobina@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
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