The effect of oral melatonin before percutaneous nephrolithotomy (PCNL) on the incidence of SIRS and sepsis and postoperative outcomes and complications: a double-blind randomized clinical trial study
Investigating the effect of oral melatonin in patients who are candidates for percutaneous nephrolithotomy (PCNL) surgery on the occurrence of surgical complications and its results.
Design
The study is an interventional study in two control groups (52 people) and intervention (52 people), two-way blind (patient and researcher), phase 3, parallel and diagnostic. For randomization, permuted balanced block randomization method was used by creating blocks of four between Two treatment and control groups will be used randomly.
Settings and conduct
This clinical trial will be conducted on 104 patients at Sina Hospital, Urology Research Center. The first group: PCNL treatment group with melatonin consumption: 52 patients and the second group: PCNL control group with placebo consumption: 52 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are in the age range of 20 to 55 years and are candidates for PCNL surgery with general anesthesia and will sign the consent form. Exclusion criteria: history of neuro-psychiatric diseases such as depression and schizophrenia, cardiovascular and cerebrovascular diseases; the use of tranquilizers and beta blockers and hypnotics or narcotic painkillers, the presence of drug sensitivity; Estimated duration of anesthesia > 4 hours.
Intervention groups
Intervention group: percutaneous nephrolithotomy surgery (PCNL) along with melatonin: 52 patients
Control group: percutaneous nephrolithotomy surgery (PCNL) along with placebo: 52 patients
Main outcome variables
Incidence of systemic response syndrome (SIRS), sepsis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N26
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-26, 1403/06/05
Expected recruitment end date
2025-08-27, 1404/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral melatonin before percutaneous nephrolithotomy (PCNL) on the incidence of SIRS and sepsis and postoperative outcomes and complications: a double-blind randomized clinical trial study
Public title
The effect of oral melatonin before percutaneous nephrolithotomy surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 20 to 55 years
Candidate for PCNL surgery under general anesthesia
Written and informed consent from patients
Exclusion criteria:
Neuro-psychiatric diseases such as depression and schizophrenia
Heart diseases and brain treatment
The use of sedatives and beta blockers and sleeping pills or pain relievers
Existence of drug sensitivity
Estimated duration of anesthesia>4 hours
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, Permuted balanced block randomization method will be used by creating blocks of four between two treatment and control groups in a random way. According to the randomization method, we expect that the two groups will have a difference of at most 2 people in terms of the number of allocated people. to be After preparing the randomization sequence by the statistics and epidemiology specialist, the patients will be placed in blocks a and b. Based on the first choice, the patient will be placed as a in (PCNL group with melatonin consumption: 52 patients), the next patient will be placed as b (PCNL group with placebo consumption: 52 patients).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind, the researcher and the participant will not know about the treatment process in the PCNL group with melatonin or the PCNL group with placebo. Placebo pills look and taste similar to melatonin.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee, Sina Hospital
Street address
Room 206, Ethics Committee Office, Second Floor, Administrative Building, Sina Hospital, Imam Khomeini Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.122
Health conditions studied
1
Description of health condition studied
Kidney stones
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
Primary outcomes
1
Description
Changes in the incidence of SIRS caused by percutaneous nephrolithotomy (PCNL) due to the use and non-use of melatonin
Timepoint
24 to 48 hours after the operation
Method of measurement
Medical laboratory
2
Description
Changes in the incidence of sepsis caused by percutaneous nephrolithotomy (PCNL) due to the use and non-use of melatonin
Timepoint
24 to 48 hours after the operation
Method of measurement
Medical laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PCNL treatment group along with melatonin intake
Category
Treatment - Drugs
2
Description
Control group: PCNL with placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Sixth Floor, Central University, Quds Ave, Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center, Sinai Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers working in academic and scientific institutions, doctors, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by providing a patient's privacy.