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IRCT20160523028010N2 IRCT 2022-09-04 Hamedan University of Medical Sciences The effect of crystalloid infusion containing 2% glucose on blood pressure and heart rate in cesarean section with spinal anesthesia The effect of crystalloid infusion containing 2% glucose on hemodynamic status in cesarean section with spinal anesthesia 2022-08-06 anticipated 20 Complete https://irct.ir/trial/64306 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For this purpose, the envelope method will be used. For this purpose, four sheets of paper were prepared. The letter I will be written on two sheets and the letter C will be written on the other two sheets. The leaves are placed in the envelope and after mixing, we will put them in the table drawer. Upon referral to any of the eligible patients, one of the sheets will be randomly pulled out and based on this sheet, I or C will be assigned to one of the two intervention groups (I and control (C)). When all four sheets are accidentally pulled out, all the sheets will be returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached, Blinding description: In both groups I and C, serums containing glucose and distilled water are prepared and injected by the nurse, so the anesthesiologist who will measure and record the study outcome, also the person undergoing cesarean section will not know the type of drug prescribed did not have. N/A Hemodynamic change during cesarean. Intervention 1: Intervention group: pregnant women receiving Ringer's serum containing 2% glucose20 grams of glucose are added per liter of Ringer's serum, after the pregnant woman is placed on the surgical bed, the infusion of Ringer's serum containing glucose starts and continues until the end of the surgery. The mother's blood sugar is measured before and after the surgery.The baby's blood sugar is checked immediately after birth and one hour after that.Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate are measured before the start of spinal anesthesia, immediately after spinal anesthesia, every two minutes to ten minutes, and then every ten minutes until the end of the surgery. Shivering, nausea and vomiting, if any, are recorded until the end of the operation. If the systolic pressure is less than 90 mmHg, 20-5 mg of ephedrine and the heart rate is less than 50 per minute, 0.5 mg of atropine is injected. Intervention 2: Control group: pregnant women receiving Ringer's serum Normal saline is added per liter of Ringer's serum, equivalent to the volume of glucose added in the intervention group. After the pregnant woman is placed on the surgical bed, Ringer's serum infusion starts and continues until the end of the surgery. The mother's blood sugar is measured before and after the surgery. The baby's blood sugar is checked immediately after birth and one hour after that, systolic, diastolic and average blood pressure and heart rate are measured before starting spinal anesthesia, immediately after spinal anesthesia, every two minutes to ten minutes, and then every ten minutes until the end of surgery. Shivering, nausea, and vomiting, if any, are recorded until the end of the procedure. If the systolic pressure is less than 90 mmHg, 20-5 mg of ephedrine and the heart rate is less than 50 per minute, 0.5 mg of atropine is injected. 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 The possibility of adding a new participant
public Pouran Hajian
Hamadan university of medical sciences Faculty of medicine ,Shahid Fahmideh Blvd
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 hajian@umsha.ac.ir Hamedan University of Medical Sciences scientific Pouran Hajian
Hamadan University of Medical Science,Faculty of medicine; Shahid Fahmideh Blvd
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 hajian@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age between 18 -45 year Gestational age (38-42 week) Single tone pregnancy Elective cesarean under spinal anesthesia ASA I Consent to participate in the study 18 years 45 years Female psychotic disorders BMI>35kg/m2 Emergency cesarean Systemic diseses(renal,cardiac,pulmonary,hepatic, musculoskeletal ,... disorders) Intolerance to glucose Taking drugs that affect glucose metabolism Contraindications to spinal anesthesia Allergy to bupivacaine Prevention Prevention Intervention group: pregnant women receiving Ringer's serum containing 2% glucose20 grams of glucose are added per liter of Ringer's serum, after the pregnant woman is placed on the surgical bed, the infusion of Ringer's serum containing glucose starts and continues until the end of the surgery. The mother's blood sugar is measured before and after the surgery.The baby's blood sugar is checked immediately after birth and one hour after that.Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate are measured before the start of spinal anesthesia, immediately after spinal anesthesia, every two minutes to ten minutes, and then every ten minutes until the end of the surgery. Shivering, nausea and vomiting, if any, are recorded until the end of the operation. If the systolic pressure is less than 90 mmHg, 20-5 mg of ephedrine and the heart rate is less than 50 per minute, 0.5 mg of atropine is injected. Control group: pregnant women receiving Ringer's serum Normal saline is added per liter of Ringer's serum, equivalent to the volume of glucose added in the intervention group. After the pregnant woman is placed on the surgical bed, Ringer's serum infusion starts and continues until the end of the surgery. The mother's blood sugar is measured before and after the surgery. The baby's blood sugar is checked immediately after birth and one hour after that, systolic, diastolic and average blood pressure and heart rate are measured before starting spinal anesthesia, immediately after spinal anesthesia, every two minutes to ten minutes, and then every ten minutes until the end of surgery. Shivering, nausea, and vomiting, if any, are recorded until the end of the procedure. If the systolic pressure is less than 90 mmHg, 20-5 mg of ephedrine and the heart rate is less than 50 per minute, 0.5 mg of atropine is injected. Changes in blood pressure. Timepoint: Upon arrival, before and immediately after the spinal and every 2 minutes to the first ten minutes and then every 10 minutes until the end of the operation was recorded. Method of measurement: Standard monitoring device. Changes of Heart rate. Timepoint: Upon arrival, before and immediately after the spinal and every 2 minutes to the first ten minutes and then every 10 minutes until the end of the operation was recorded. Method of measurement: Standard monitoring device. Percent of patient with blood pressure less than 90 mmHg. Timepoint: none. Method of measurement: Standard monitoring device. Percent of patient with heart rate less than 50 per minute. Timepoint: none. Method of measurement: Standard monitoring device. Nausea and vomiting. Timepoint: Every two minutes for ten minute and then every ten minute until end of surgery. Method of measurement: through observation. Chills through observation. Timepoint: Every two minutes for ten minute and then every ten minute until end of surgery. Method of measurement: through observation. Hypoglycemia or hyperglycemia in mother. Timepoint: before surgery and at the end of surgery,. Method of measurement: based on Glucometery measurements. Hypoglycemia or hyperglycemia in infant. Timepoint: immediately after birth and one hour after birth. Method of measurement: based on Glucometery measurements. Hamedan University of Medical Sciences Approved 2022-05-08 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Science, Shahid Fahmideh Blvd Hamadan Hamadan Iran (Islamic Republic of)