Comparison of the effects of melatonin and gabapentin on shivering after knee surgery under spinal anesthesia in patients referred to the operating room of Imam Reza Hospital in 1404.
Design
The samples are included in the study as they are available and if they meet the inclusion criteria. They are divided into two groups A and B by using white and block cards according to randomized method. Sample size: Considering the potential of those referred to the hospital operating room and the available samples, 100 samples are determined as the size, which will be studied in two groups of 51 people.
Settings and conduct
After entering the operating room of 501 AJA hospital, to perform spinal anesthesia, first they receive 10 ml/kg of preloaded Ringer's serum fluid, which is kept at 22 (8) degrees Celsius in the operating room, and then they are placed in a sitting position with a 25-gauge spinal needle and injected with 3 injections of 0.5% bupivacaine.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- All patients aged 20-60
2- Patients with (II, I) ASA
3- No history of taking antidepressants with catecholamine or serotonin reuptake mechanisms (15, 16, 18)
4- Completed informed consent by the patient (after full explanation about the safety and health of the various stages of the plan and obtaining informed consent)
Exclusion criteria :
1- Blood transfusion and its cold products during surgery
2- Patient or project manager's awareness of the type of medication prescribed
3- Lack of consent of the patient or companions for any reason during the implementation of the project
Intervention groups
Group A is prescribed melatonin at a dose of 5 mg and Group B is prescribed gabapentin at a dose of 100 mg as a single dose orally with 50 cc of water one hour before the procedure.
Main outcome variables
Shivering
Nausea and vomiting
Sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110103005536N13
Registration date:2025-09-09, 1404/06/18
Registration timing:prospective
Last update:2025-09-09, 1404/06/18
Update count:0
Registration date
2025-09-09, 1404/06/18
Registrant information
Name
Mohamadreza Rafiei
Name of organization / entity
Artesh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8933
Email address
mo_rafiei@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-21, 1404/07/29
Expected recruitment end date
2026-05-20, 1405/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two drugs melatonin and gabapentin on shivering after knee surgery with spinal anesthesia
Public title
Comparison of the effects of melatonin and gabapentin on shivering after knee surgery with spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients that are 20-60 years old
Patients with (II, I) ASA
No history of taking antidepressants with catecholamine or serotonin reuptake mechanisms (15, 16, 18)
Completion of informed consent by the patient (after full explanation about the safety and health of the various stages of the plan and obtaining informed consent)
Exclusion criteria:
Infusion of blood and its cold products during surgery
Patient or project manager's awareness of the type of medication prescribed
Dissatisfaction of the patient or companions for any reason during the implementation of the plan
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization using black and white cards.patients are divided into two intervention and control groups. scince the sampling is conveneince or available the first patient who visits is randomly assighed to the melatonin group(if shivering occurs ) by receiving a white card and the next pateint who receives a black card is assighed to the gabapentin group(if shivering occurs).
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is conducted in adouble blinded manner; in this way, the person who performs the statistical analysis and records the necessary variables in each patient, the physician performing the procedure, and the patients themselves are unaware of the type of medication prescribed
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of AJA University of Medical Sciences
Street address
Etemadzadeh St. Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2025-07-30, 1404/05/08
Ethics committee reference number
IR.AJAUMS.REC.1404.102
Health conditions studied
1
Description of health condition studied
Shivering after surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering
Timepoint
Immediately after surgery until discharge from recovery
Method of measurement
According to the four criteria for grading postoperative tremor (table 1 mentioned in the proposal)
2
Description
Nausea and vomiting
Timepoint
Immediately after surgery until discharge from recovery
Method of measurement
By observing and assessing clinical symptoms and asking the patient questions
3
Description
Sedation
Timepoint
Immediately after surgery until discharge from recovery
Method of measurement
Any and all degrees of unresponsiveness to auditory and tactile stimuli According to the table grading of sedation(Table 2 mentioned in the proposal)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For group A, melatonin is administered as a single dose of 5 mg orally with 50 cc of water one hour before the operation. Then, after entering the operating room, for spinal anesthesia, they first receive 10 ml/kg of preloaded Ringer's serum fluid, which is kept at 22°C in the operating room, and then they are placed in a sitting position with a 25-gauge spinal needle and injected with 3 injections of 0.5% bupivacaine.
Category
Treatment - Drugs
2
Description
Intervention group: For group B, Gabapentin is administered as a single dose of 5 mg orally with 50 cc of water one hour before the operation. Then, after entering the operating room, for spinal anesthesia, they first receive 10 ml/kg of preloaded Ringer's serum fluid, which is kept at 22°C in the operating room, and then they are placed in a sitting position with a 25-gauge spinal needle and injected with 3 injections of 0.5% bupivacaine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
501AJA hospital
Full name of responsible person
Dr. Mohammadreza rafiei
Street address
Etemadzadeh St. , West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 6350 8609
Email
mo_rafiei@armyums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr. Reza Mosaed
Street address
West fatemi, Etemadzadeh st.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Reza.mosaed@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army 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
Artesh University of Medical Sciences
Full name of responsible person
Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street. West fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8933
Fax
+98 31 1263 1587
Email
mo_rafiei@armyums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street. West fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8933
Fax
+98 31 1263 1587
Email
mo_rafiei@armyums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street. West fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8933
Fax
+98 31 1263 1587
Email
mo_rafiei@armyums.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
All research sata can be shared after unidentifying individuals
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
All researchers in the field of anesthesia and only by mentioning the source
Under which criteria data/document could be used
It can be used only for therapeutic and research purposes and by mentioning the source
From where data/document is obtainable
Dr. Mohammadreza Rafiei
What processes are involved for a request to access data/document
Send a request email to Dr. Rafiei and receive the data if the user approves