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IRCT2016110730770N1 IRCT 2017-03-18 Vice chancello forresearch, Zahedan university of Medical Sciences Comparison the effect of serum therapy(Ringer,D/S&HES) before spinal anesthesia in elective cesarean section on patients' hemodynamic with out acronym Comparison the effect of serum therapy(Ringer,D/S&HES) before spinal anesthesia in elective cesarean section on patients' hemodynamic 2017-01-19 anticipated 90 Complete https://irct.ir/trial/24346 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: 2. The study population (inclusion and exclusion criteria are listed): The study population consisted of all mothers pregnant first parity cesarean elective surgery during 1395 in Imam Ali hospital and placed under spinal anesthesia. 2-3 Effects of intravenous therapy with D/S’ringer or hydroxi ethyl starch in spinal anesthesia for elective cesarean section on patient’s hemodynamic. Intervention 1: Random, double-blind study designed and After approval by the university ethics committee and recorded in clinical studies in the Iranian system Refer to all pregnant women for elective cesarean section and are part of the inclusion criteria Offering fully explained consent form and the trial is conducted and from them satisfaction. In this study, 90 women with normal pregnancy 40-20 years with ASA class 1 and 2 and a height of 160-180 cm are now. This clinical trial, in which each group of 30 selected and matched undertaking uncomplicated elective cesarean section after informed consent of the patients in this study are. This is a double-blind study, the researcher is a person who collects information relevant group are totally unaware. After a full explanation and written informed consent from the patient eligible patients will be enrolled in the study. And the timely arrival of the patient to the operating room the patient's Put a wedge under the right side of the patient to prevent pressure on the lower venacava. The standard monitoring, including ECG (electrocardiogram) and NIBP (Non-Invasive Blood Pressure) and HR (heart rate) and SPo2 (percentage of oxygen in arterial blood) are placed. The patient is placed in the supine on a bed operating room and placed in such a way that the right hip 15-degree wedge up. Vital signs include BP-HR-MAP is assorted LoginRegister. Serum interest at a rate of 10cc/kg. injected into 15 to 30 minutes. Vital signs (HR-MAP-BP) is recorded. Then the patient in the sitting position after preb with bethadine; space L3-L4 or L4-L5 using 12/5 mg of bupivacaine 0/5% plus 25 micrograms fentanyl with needle number Gage24 or 25 Gage (needle type is Quincke) under spinal anesthesia by a person qualified or project is. (If the number of attempts for spinal anesthesia (injection) is more than 3 times patient out of the study). The patient is placed supine position immediately. Vital signs are recorded immediately. This operation is repeated for 2 hours every 2 minutes to 15 minutes, then every 10 minutes until the end of the second hour trademarks. In the period after spinal anesthesia if the systolic blood pressure lower than 100 mm Hg or 25% compared to the initial pressure drop immediately treated with ephedrine 5 mg IV start until the patient's blood pressure is higher than 100 mm Hg reach every 2 minutes, repeat. Three times after treatment begins with ephedrine treatment with epinephrine. Interventions,is the injection of 10 ml per kilogram of body weight of the serum before spinal anesthesia (only medication is the sugar-salt or hydroxi ethyl starch 6% or ringer only once.). There is no control group. Intervention 2: The first intervention: an injection of 10 cc of Dexteros-salin serum per kg of body weight before spinal anesthesia (only once) for 15 minutes. Then measure the blood pressure numbers mean arterial blood pressure and heart rate, arterial blood oxygen saturation by anesthesia machine. Measuring is every 2 minutes to 15 minutes, then every 10 minutes until 2 hours after the onset of spinal anesthesia .no control group . Intervention 3: Second intervention: an injection of 10 cc of Ringer per kg of body weight before spinal anesthesia (only once) for 15 minutes. Then measure the blood pressure numbers mean arterial blood pressure and heart rate, arterial blood oxygen saturation by anesthesia machine. Measuring is every 2 minutes to 15 minutes, then every 10 minutes until 2 hours after the onset of spinal anesthesia .no control group . Intervention 4: Third intervention:an injection of 10 cc of Hydroxi ethil estarch 6% per kg of body weight before spinal anesthesia (only once) for 15 minutes. Then measure the blood pressure numbers mean arterial blood pressure and heart rate, arterial blood oxygen saturation by anesthesia machine. Measuring is every 2 minutes to 15 minutes, then every 10 minutes until 2 hours after the onset of spinal anesthesia .no control group .
public DR. Birami. Faranak
Zahedan university of medical sciences، Janat pardis Blvd، DR، Hesabi square، Daneshgah Street
Zahedan Iran (Islamic Republic of) 9816743463 +98 543329571522 public@zaums.ac.ir Zahedan university of Medical sciences scientific DR.Birami، Faranak
Zahedan university of medical sciences، Janat pardis Blvd، DR، Hesabi square، Daneshgah Street
Zahedan Iran (Islamic Republic of) 9816743463 +98 543329571522 public@zaums.ac.ir Zahedan university of Medical sciences Iran (Islamic Republic of) Inclusion criteria: Twenty to forty years with normal pregnancy؛ with ASA class 1 and 2؛ with a height of 160-180 cm Exclusion criteria: neuromuscular disorders؛ and neurological diseases؛ heart disease؛ high blood pressure؛ diabetes؛ organ failure؛ drug abuse؛ coagulation disorders؛ BMI more than 30 before pregnancy" and pre-eclampsia or eclampsia. 20 years 40 years Female N/A N/A N/A N/A Random, double-blind study designed and After approval by the university ethics committee and recorded in clinical studies in the Iranian system Refer to all pregnant women for elective cesarean section and are part of the inclusion criteria Offering fully explained consent form and the trial is conducted and from them satisfaction. In this study, 90 women with normal pregnancy 40-20 years with ASA class 1 and 2 and a height of 160-180 cm are now. This clinical trial, in which each group of 30 selected and matched undertaking uncomplicated elective cesarean section after informed consent of the patients in this study are. This is a double-blind study, the researcher is a person who collects information relevant group are totally unaware. After a full explanation and written informed consent from the patient eligible patients will be enrolled in the study. And the timely arrival of the patient to the operating room the patient's Put a wedge under the right side of the patient to prevent pressure on the lower venacava. The standard monitoring, including ECG (electrocardiogram) and NIBP (Non-Invasive Blood Pressure) and HR (heart rate) and SPo2 (percentage of oxygen in arterial blood) are placed. The patient is placed in the supine on a bed operating room and placed in such a way that the right hip 15-degree wedge up. Vital signs include BP-HR-MAP is assorted LoginRegister. Serum interest at a rate of 10cc/kg. injected into 15 to 30 minutes. Vital signs (HR-MAP-BP) is recorded. Then the patient in the sitting position after preb with bethadine; space L3-L4 or L4-L5 using 12/5 mg of bupivacaine 0/5% plus 25 micrograms fentanyl with needle number Gage24 or 25 Gage (needle type is Quincke) under spinal anesthesia by a person qualified or project is. (If the number of attempts for spinal anesthesia (injection) is more than 3 times patient out of the study). The patient is placed supine position immediately. Vital signs are recorded immediately. This operation is repeated for 2 hours every 2 minutes to 15 minutes, then every 10 minutes until the end of the second hour trademarks. In the period after spinal anesthesia if the systolic blood pressure lower than 100 mm Hg or 25% compared to the initial pressure drop immediately treated with ephedrine 5 mg IV start until the patient's blood pressure is higher than 100 mm Hg reach every 2 minutes, repeat. Three times after treatment begins with ephedrine treatment with epinephrine. Interventions,is the injection of 10 ml per kilogram of body weight of the serum before spinal anesthesia (only medication is the sugar-salt or hydroxi ethyl starch 6% or ringer only once.). There is no control group. The first intervention: an injection of 10 cc of Dexteros-salin serum per kg of body weight before spinal anesthesia (only once) for 15 minutes. Then measure the blood pressure numbers mean arterial blood pressure and heart rate, arterial blood oxygen saturation by anesthesia machine. Measuring is every 2 minutes to 15 minutes, then every 10 minutes until 2 hours after the onset of spinal anesthesia .no control group . Second intervention: an injection of 10 cc of Ringer per kg of body weight before spinal anesthesia (only once) for 15 minutes. Then measure the blood pressure numbers mean arterial blood pressure and heart rate, arterial blood oxygen saturation by anesthesia machine. Measuring is every 2 minutes to 15 minutes, then every 10 minutes until 2 hours after the onset of spinal anesthesia .no control group . Third intervention:an injection of 10 cc of Hydroxi ethil estarch 6% per kg of body weight before spinal anesthesia (only once) for 15 minutes. Then measure the blood pressure numbers mean arterial blood pressure and heart rate, arterial blood oxygen saturation by anesthesia machine. Measuring is every 2 minutes to 15 minutes, then every 10 minutes until 2 hours after the onset of spinal anesthesia .no control group . Saturation Pressure of arterial oxygen. Timepoint: Every 10 minutes to two hours. Method of measurement: Is performed by anesthesia machine. Blood pressure, heart rate-MAP-spo2. Timepoint: Every 10 minutes to two hours. Method of measurement: All is done by anesthesia machine. Heart rate. Timepoint: Every 10 minutes to two hours. Method of measurement: Is performed by anesthesia machine. Mean arterial pressure. Timepoint: Every 10 minutes to two hours. Method of measurement: Is performed by anesthesia machine. No variable. Timepoint: does not have. Method of measurement: does not have. does not have does not have ندارد ندارد Vice chancello forresearch, Zahedan university of Medical Sciences Approved 2016-01-29 Ethics Committee of the Zahedan University of Medical Sciences Zahedan university of medical sciences، Janat pardis Blvd، DR، Hesabi square، Daneshgah Street Zahedan Iran (Islamic Republic of)