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IRCT20120915010841N13 IRCT 2019-03-04 Hamedan University of Medical Sciences The effect of Patient's position on post spinal anesthesia hypotension Comparison of sitting and lateral position during spinal anesthesia on maternal Sensory block Level and hemodynamics effect in cesarean section 2018-12-22 anticipated 106 Complete https://irct.ir/trial/37586 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study , a randomized block design with four replications is used. we provide four paper sheets . We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and will be assigned to one of the two sitting or lateral position groups, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume, Blinding description: Patients in Group A are in the sitting position and patients in Group B are placed in the right lateral position and they are under spinal anesthesia by anesthesiologist .Then the patients are immediately placed in supine position and evaluate by assessing who does not know the patients' classification and status of patients during spinal anesthesia in the two groups that analyzes the outcomes.In this study, the evaluator and analyzer do not know the type of patient s position drug spinal anesthsia. N/A Hypotension & sensory block level during spinal anesthesia under different positions in c/s. Intervention 1: Control group: After measuring and recording the initial vital signs, the patients in group A are placed in a sitting position and under spinal anesthesia by an anesthetist in L4-L3 (mid line) with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg (2 ml) of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and then the patient is placed immediately in the supine position and the vital signs will be registered. Intervention 2: Intervention group: After measuring and recording the initial vital signs, the patients in group B are placed in a right lateral position and under spinal anesthesia by an anesthetist in L4-L3 (mid line) with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg (2 ml) of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and then the patient is placed immediately in the supine position and the vital signs will be registered. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the study is not finished yet.
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) parturients aged 18 to 45 years old Candidates for cesarean section under spinal anesthesia ASA Physical Class 1 and 2 18 years 45 years Female Heart disease Hypertension Eclampsia & pre-eclampsia Diabetes Those who are reluctant to continue to participate in the study Patients who have failed spinal anesthesia and undergo general anesthesia Spinal anesthesia Contraindications (High ICP, coagulation problems, shock, anemia) 074.6 En Other complications of spinal and epidural anaesthesia during labour and delivery Prevention Prevention Control group: After measuring and recording the initial vital signs, the patients in group A are placed in a sitting position and under spinal anesthesia by an anesthetist in L4-L3 (mid line) with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg (2 ml) of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and then the patient is placed immediately in the supine position and the vital signs will be registered. Intervention group: After measuring and recording the initial vital signs, the patients in group B are placed in a right lateral position and under spinal anesthesia by an anesthetist in L4-L3 (mid line) with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg (2 ml) of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and then the patient is placed immediately in the supine position and the vital signs will be registered. Maximum sensory level. Timepoint: Every minute to 5 minutes. Method of measurement: Determination of sensory level by needle (Pinprick). Onset time of sensory block. Timepoint: Every minute until the sensory block is fixed. Method of measurement: In minutes using the clock. Systolic and Diastolic Blood Pressure. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minute. Method of measurement: Non-invasive automatic barometric device. Heart Rate. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minute. Method of measurement: Non-invasive automatic barometric device. Nausea and Vomiting. Timepoint: During surgery. Method of measurement: View and ask the patient. Satisfaction. Timepoint: End of surgery. Method of measurement: Question from the patient. Need for ephedrine. Timepoint: End of surgery. Method of measurement: Calculate consumed ephedrine. Need for atropine. Timepoint: End of surgery. Method of measurement: Calculate consumed atropine. Hamedan University of Medical Sciences Approved 2018-09-01 Ethics Committee of Hamadan university of medical sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)