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IRCT20110103005536N13 IRCT 2025-09-09 Army University of Medical Sciences Comparison of the effects of melatonin and gabapentin on shivering after knee surgery with spinal anesthesia Comparison of two drugs melatonin and gabapentin on shivering after knee surgery with spinal anesthesia 2025-10-21 anticipated 100 Complete https://irct.ir/trial/85421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Shivering after surgery. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All research sata can be shared after unidentifying individuals When: Start the access period after printing the results To whom: All researchers in the field of anesthesia and only by mentioning the source Conditions: It can be used only for therapeutic and research purposes and by mentioning the source Where to obtain: Dr. Mohammadreza Rafiei How to obtain: Send a request email to Dr. Rafiei and receive the data if the user approves Comments:
public Mohamadreza Rafiei
Etemadzadeh street. West fatemi
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8802 8933 mo_rafiei@armyums.ac.ir Artesh University of Medical Sciences scientific Mohamadreza Rafiei
Etemadzadeh street. West fatemi
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8802 8933 mo_rafiei@armyums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) 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) 20 years 60 years Both 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 Treatment - Drugs Treatment - Drugs 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. 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. 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). 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. 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). Army University of Medical Sciences Approved 2025-07-30 Research Ethics Committee of AJA University of Medical Sciences Etemadzadeh St. Fatemi St. Tehran Tehran Iran (Islamic Republic of)