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IRCT20160202026328N7 IRCT 2022-01-10 Tabriz University of Medical Sciences The effect of hyperbaric bupivacaine dosage on the incidence and severity of early complications after spinal anesthesia for orthopedic surgeries The effect of hyperbaric bupivacaine dosage on the incidence and severity of early complications after spinal anesthesia for orthopedic surgeries 2021-12-22 anticipated 60 Complete https://irct.ir/trial/61035 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be selected based on inclusion and exclusion criteria and will be randomly assigned to treatment groups using permuted blocks. For randomization, the Rand function of Excel software is used, in which the randomization unit is individuals. Sampling will be double-blind and all the desired variables will be recorded based on a pre-prepared questionnaire, Blinding description: The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner. So that anesthesiologist is unaware of the injected drug to patient during injection. The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills the checklist during surgery and recovery. The patient is also unaware of the type of Injecting drug. 2-3 Complications of spinal anesthesia. Intervention 1: Intervention group A: Three groups named A, B and C, which are defined based on the dose of hyperbaric bupivacaine 0.5% injection into the intrathecal space. In all three groups, in order to homogenize the interventions, the temperature of the solutions is the same and spinal anesthesia will be performed in sitting position and in sterile condition with a 23G Quincke spinal needle from the L4-L5 space. The surgeries will be the same and with a fixed duration. Immediately after the injection, patients will be in the supine position, and vital signs and incidence of nausea and vomiting will be recorded at regular intervals. For intervention group A, 12.5 mg of bupivacaine will be injected to intrathecal space. Intervention 2: Intervention group B: 15 mg of hyperbaric bupivacaine 0.5% will be injected to intrathecal space. Intervention 3: Intervention group C: 20 mg of hyperbaric bupivacaine 0.5% will be injected to intrathecal space. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academia and people in industry. Conditions: There are no specific restrictions on the use of data or documentation. Where to obtain: Dr .Masoud Parish Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone: +98 413 3341994, masoudparish@yahoo.com How to obtain: Applicants will have access to the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Masoud Parish
Shohada Hospital, Gholshahr Avenue, Yaghchian, tabriz, Iran
Tabriz Iran (Islamic Republic of) 5167846171 +98 41 3385 5842 parishm@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masoud Parish
Shohada Hospital, Golshahr Avenue, Yaghchian, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5167846171 +98 41 3385 5842 parishm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Orthopedic lower limb surgeries Having an indication for spinal anesthesia Patients with ASA class I and II 18 years 60 years Both Patient discontent with spinal anesthesia Uncontrolled blood pressure in the patient Uncontrolled diabetes in the patient History of previous neurological problems in the patient Presence of coagulation problems in the patient Hypersensitivity to anesthetics Septicemia or local infection at the site of needle entry T88.59 Other complications of anesthesia Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group A: Three groups named A, B and C, which are defined based on the dose of hyperbaric bupivacaine 0.5% injection into the intrathecal space. In all three groups, in order to homogenize the interventions, the temperature of the solutions is the same and spinal anesthesia will be performed in sitting position and in sterile condition with a 23G Quincke spinal needle from the L4-L5 space. The surgeries will be the same and with a fixed duration. Immediately after the injection, patients will be in the supine position, and vital signs and incidence of nausea and vomiting will be recorded at regular intervals. For intervention group A, 12.5 mg of bupivacaine will be injected to intrathecal space. Intervention group B: 15 mg of hyperbaric bupivacaine 0.5% will be injected to intrathecal space. Intervention group C: 20 mg of hyperbaric bupivacaine 0.5% will be injected to intrathecal space. Blood pressure. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: In millimeters of mercury using a non-invasive method of measuring blood pressure by the device. Heart rate. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Beat Per minute using a non-invasive heart rate monitor. Hypoventilation and hypoxia. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Monitoring the respiratory rate per minute and measuring oxygen saturation by pulse oximetry. Nausea and vomiting. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Asking the patient. Tabriz University of Medical Sciences Approved 2021-11-29 Ethics committee of Tabriz University of Medical Sciences Faculity of Medicine, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)