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IRCT20120915010841N23 IRCT 2020-06-29 Hamedan University of Medical Sciences Evaluation of the effect of elastic bandage on Post spinal hypotension Evaluation of the effect of leg wrapping with elastic bandage for the prevention of Post spinal hypotension in cesarean section : A randomized clinical trial 2020-06-21 anticipated 64 Complete https://irct.ir/trial/48986 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 elastic bandage and control 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: In group A, immediately before spinal anesthesia, each lower limb is covered by an elastic bandage and covered by clothes. Since the bandage is performed by an anesthesiologist, the assistant who will measure and record the study result will not know if the bandage has been performed or not. N/A Post spinal anesthesia hypotension in C/S. Intervention 1: Intervention group: Immediately before the spinal anesthesia, first lower limbs are high held for 1 minute at a 45-degree for venous derenage, second elastic bandages(a length of 4 meters and a width of 15 centimeters) are tied from ankles to the knees and limbes will be covered by clothes. Intervention 2: Control group: They are subjected to spinal anesthesia without the use of elastic bandages. 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) Patients aged 18 to 46 years With term pregnancy (37 weeks and more) Physical Status (ASA) Class 1 and 2 Candidate for cesarean section under spinal anesthesia Satisfaction to participate in the research 18 years 46 years Female Patients with respiratory disease Hypertension Diabetes Heart failure and cardiac arrhythmia Multiple pregnancies Eclampsia and preeclampsia Emergency cesarean section Prevention Prevention Intervention group: Immediately before the spinal anesthesia, first lower limbs are high held for 1 minute at a 45-degree for venous derenage, second elastic bandages(a length of 4 meters and a width of 15 centimeters) are tied from ankles to the knees and limbes will be covered by clothes. Control group: They are subjected to spinal anesthesia without the use of elastic bandages Hypotension. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15minutes, then every 10 minutes until the end of the surgery. Method of measurement: Automatic non-invasive blood pressure device. Systolic and Diastolic Blood Pressure. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery. Method of measurement: En Automatic non-invasive blood pressure device. Heart Rate. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery. Method of measurement: pulse oximetry. Nausea and Vomiting. Timepoint: During and after surgery. Method of measurement: Observation. New born Apgar. Timepoint: 1&5 minutes after delivery. Method of measurement: Apgar Score. The amount of ephedrine have been consumed. Timepoint: During surgery. Method of measurement: mg. The amount of atropine have been consumed. Timepoint: During surgery. Method of measurement: mg. Hamedan University of Medical Sciences Approved 2020-06-13 Ethics Committee of Hamadan University of Medical Sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)