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IRCT20231021059799N1 IRCT 2024-04-15 Iran University of Medical Sciences Comparison of the effects of intravenous ketamine and intravenous tramadol in the prevalence of shivering after spinal anesthesia Comparison of the effects of intravenous ketamine and intravenous tramadol in the prevalence of shivering after spinal anesthesia in urological surgeries 2024-04-09 anticipated 90 Complete https://irct.ir/trial/76136 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization Allocation: In this study, a randomized block method is utilized using six-member blocks with random order. Then, patients meeting the inclusion criteria will be allocated to groups based on block randomization. (In this method, treatment blocks will be randomly rotated, generating various permutations with blocks of six for three groups, such as ABCABC-BACABC-ABCBAC-ABCCBA... and these permutations will continue until the sample size is reached). Blocks will be randomly selected using Excel software and provided to a researcher who has no involvement in intervention selection. A numerical code will be assigned to each of the created randomization chains. Then, the drug regimen will be packed according to the randomization chains, and after sealing the packets, a unique code will be written on them, and these packets will be randomly placed in a box. The generated code for patients and the type of drug regimen received will also be recorded and maintained by the study epidemiologist who has access to the randomization chain, Blinding description: This research will be triple blind. Because the patients are unconscious, they are unaware of the type of intervention received. The researcher will be unaware of the type of interventions. an examiner who checks the degree of shivering before and after treatment; will be unaware of the group and treatments of the patients, and there will be a briefing session on how to fill in the questionnaire items (especially the qualitative variables) for the people who are in charge of collecting the samples; will be held Also, the statistical analyst will be unaware of the group and treatments of the patients. 3 Post Anesthesia Shivering. Intervention 1: Intervention Group: Patients who immediately receive an intravenous dose of ketamine at a dose of 0.5 mg/kg after spinal anesthesia will be referred to as the ketamine group. Intervention 2: Intervention Group: Patients who immediately receive an intravenous dose of tramadol at a dose of 0.5 mg/kg after spinal anesthesia will be referred to as the tramadol group. Intervention 3: Control Group: Patients who immediately after spinal anesthesia receive normal saline in the same volume as the drug injected to the intervention groups will be prescribed as the placebo. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome or similar, can be shared. When: Access period 6 months after publication of results. To whom: It will be available only for researchers working in academic and scientific institutions. Conditions: No special conditions are considered. Where to obtain: The person responsible for the study of Siavash Sangi. siavash sangi@gmail.com How to obtain: After receiving the applicant's email, the documents will be sent in a short period of time. Comments:
public Siavash Sangi
No. 30, Eastern Blvd., Arash Mehr St., Shahrara.
Tehran Iran (Islamic Republic of) 1445873167 0989189003460 siavashsangi@gmail.com Iran University of Medical Sciences scientific Siavash Sangi
No. 30, Eastern Blvd., Arash Mehr St., Shahrara.
Tehran Iran (Islamic Republic of) 1445873167 +98 918 900 3460 siavashsangi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age group: 18 to 70 years old Physical status according to ASA classification classes I, II, and III 18 years 70 years Both Patients with contraindications to spinal anesthesia and presence of infection at the site of spinal anesthesia injection, Lack of personal consent, Obesity with BMI > 38 kg/m2, Uncontrolled type 1 and 2 diabetes mellitus, Uncontrolled hypertension history, Moderate to severe valvular heart diseases, Neurological and psychiatric disorders such as stroke, history of brain lesions, obsessive-compulsive disorder, and schizophrenia, Fever exceeding 37.5 degrees Celsius at the beginning of the surgery, Patients with sensitivity to ketamine and its derivatives, Patients with sensitivity to tramadol and its derivatives, History of alcohol consumption, drug abuse, or misuse of sedatives-hypnotics and glucocorticosteroids, Presence of fungal and viral infections, Excessive bleeding, Receipt of blood products, Prolonged surgery duration exceeding three hours, History of recurrent nausea and vomiting following previous urological surgeries, Patients whose operating room drapes become wet during surgery. T88.5 Other complications of anesthesia Prevention Prevention Placebo Intervention Group: Patients who immediately receive an intravenous dose of ketamine at a dose of 0.5 mg/kg after spinal anesthesia will be referred to as the ketamine group. Intervention Group: Patients who immediately receive an intravenous dose of tramadol at a dose of 0.5 mg/kg after spinal anesthesia will be referred to as the tramadol group. Control Group: Patients who immediately after spinal anesthesia receive normal saline in the same volume as the drug injected to the intervention groups will be prescribed as the placebo. Shivering after spinal anesthesia in urological surgeries. Timepoint: The severity of patient's shivering will be recorded in the questionnaire every two hours post-operation and at any moment tremor symptoms occur in the patient. Method of measurement: The valid criterion for the grading of shivering is based on the 5-point scoring system of Crossley Mahajan. Iran University of Medical Sciences Approved 2024-01-01 Ethics Committee of Iran University of Medical Sciences Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)