]>
IRCT20220501054718N1 IRCT 2022-08-02 Gonabad University of Medical Sciences the efficacy of intravenous midazolam on maternal hemodynamic status and neonatal apgar score in cesarean section under spinal anesthesia the efficacy of intravenous midazolam on maternal hemodynamic status and neonatal apgar score in cesarean section under spinal anesthesia 2022-08-01 anticipated 108 Complete https://irct.ir/trial/63387 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation using permutation blocks. In this way, in the permutation block method of four, the letter A will represent the intervention group and the letter B will represent the control group. There are six possible states in blocks of four ABBA, AABB, BAAB, BBAA, ABAB, BABA, one number will be assigned to each block and each time one number will be selected by lottery and the patients will enter the study in order, Blinding description: Considering that this research compares the results of midazolam injection to the mother before and after the baby is born, a consent form explaining the possible positive and negative effects of midazolam will be given to the patient. However, the patient is not told which of the intervention groups (midazolam injection before the start of the spinal cord) and control (midazolam injection after the baby is discharged) will be placed, and in this sense the patient will be kept blind. 2-3 Condition 1: Hemodynamic status. Condition 2: Neonate Apgar score. Intervention 1: Intervention group: The intervention group will be intravenously injected with midazolam at a bolus dose of 0.02 miligram per kilogram 10 minutes before the start of spinal anesthesia (that is, at the start of fluid therapy). The ampoule of midazolam used in this research is 5 miligram per 1 milliliter and is a product of Tehran Chemical Company, which is diluted with 4 milliliter of distilled water. (concentration 5 miligram per 5 milliliter ). Intervention 2: Control group: This group will receive intravenous midazolam with a bolus dose of 0.02 miligram per kilogram after the birth of the baby. (common treatment). The ampoule of midazolam used in this research is 5 miligram per 1 milliliter and is a product of Tehran Chemical Company, which is diluted with 4 milliliter of distilled water. (concentration 5 miligram per 5 milliliter ). Yes - There is a plan to make this available What will be shared: The data related to the main outcome will be shared in the extracted article. When: After the publication of the results and probably in the winter of 1401 To whom: Available to other researchers Conditions: Meta-analysis and related statistical tests Where to obtain: Vice Chancellor for Research and Technology of Gonabad University of Medical Sciences How to obtain: Request to the Vice Chancellor for Research, Referral to the School of Paramedical, Referral to the Department of Anesthesiology and the relevant researcher Comments:
public Dr. Arash Hamzei
No. 48,Emam Ali Ave.
Gonabad Iran (Islamic Republic of) 9691986765 +98 51 5725 4222 Hamzeie.a@gmu.ac.ir Gonabad University of Medical Sciences scientific Dr. Arash Hamzei
No. 48, Emam Ali Ave.
Gonabad Iran (Islamic Republic of) 9691986765 +98 51 5725 4222 Hamzeie.a@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) Pregnant patient who is a candidate for cesarean section with spinal anesthesia Mother's satisfaction Term fetus Anesthesia class 1 or 2 Absence of history of mental disorders Body mass index less than 35 No history of preeclampsia Age range 45-18 years Absence of fetal distress No history of eclampsia No history of taking psychotropic drugs Fetus without anomalies 18 years 45 years Female Improper condition of the fetus during pregnancy (fetal distress) A fetus that is going to be born before the 37th week of pregnancy (preterm) Severe systemic disease (hepatitis, diabetes, Chronic obstructive pulmonary disease(COPD), End-stage kidney disease(ESRD), alcohol dependence) High blood pressure during pregnancy Emergency caesarean section The presence of any abnormality in the fetus History of seizures during pregnancy JB22.0 KB21 Delivery by elective caesarean section Birth asphyxia Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will be intravenously injected with midazolam at a bolus dose of 0.02 miligram per kilogram 10 minutes before the start of spinal anesthesia (that is, at the start of fluid therapy). The ampoule of midazolam used in this research is 5 miligram per 1 milliliter and is a product of Tehran Chemical Company, which is diluted with 4 milliliter of distilled water. (concentration 5 miligram per 5 milliliter ) Control group: This group will receive intravenous midazolam with a bolus dose of 0.02 miligram per kilogram after the birth of the baby. (common treatment). The ampoule of midazolam used in this research is 5 miligram per 1 milliliter and is a product of Tehran Chemical Company, which is diluted with 4 milliliter of distilled water. (concentration 5 miligram per 5 milliliter ) Hemodynamic factors. Timepoint: Before starting spinal anesthesia, every 5 minutes during the procedure. Method of measurement: monitoring. Neonatal Apgar. Timepoint: The first minute and the fifth minute after birth. Method of measurement: Neonatal Apgar score checklist. Gonabad University of Medical Sciences Approved 2022-05-07 Ethics committee of Gonabad University of Medical Sciences No. 0, Imam Khomeini Street, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)