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IRCT20181107041590N1 IRCT 2019-01-05 Gorgan University of Medical Sciences Comparison the effect of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases Comparison the effect of interathecal injection of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases of women undergoing cesarean delivery under spinal anesthesia 2019-01-10 anticipated 82 Complete https://irct.ir/trial/36382 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block balanced randomization method will be used. Randomization sequence will be generated by free website available from: www.randomization.com, in which letter A and B will be considered for intervention and control group, respectively. For random allocation concealment, cards containing blocks will be inserted in standard envelopes, Blinding description: In this double blind study, patient and pain assessor are not aware of allocated groups. Main investigator is not aware of the pain pump content. 3 Cesarean delivery. Intervention 1: Intervention group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) plus 5 μg of Dexmedetomidine (Pfizer company, US) (total volume of 3.0 ml). Intervention 2: Control group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) with half a milliliter of 0.9 % saline (Shahid Ghazi pharmaceutical company) (total volume of 3.0 ml). Yes - There is a plan to make this available What will be shared: After making data unrecognizable, all data will be shared. When: Starting in January 2020 To whom: It will be available for researchers working in academic institutions. Conditions: For people who have academic education and those data can be useful for their research Where to obtain: Dr. Ali Jabbari: Amir_a_72@yahoo.com How to obtain: Email to "Amir_a_72@yahoo.com" and comment that why he/she wants to access to these data Comments:
public Monireh Jahani
5th Azar street, 5 Azar tertiary hospital, Gorgan town
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3232 0370 jahani.mn@goums.ac.ir Gorgan University of Medical Sciences scientific Ali Jabbari
5th Azar street, 5 Azar tertiary hospital, Gorgan town
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3232 0370 Amir_a_72@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Pregnant women with repeated cesarean delivery and more than 39 gestational age Age between 18 to 40 years old Candidate for elective cesarean delivery underwent spinal anesthesia American Society of Anesthesiologists (ASA) physical status classification system I and II Without history of asthma, cardiovascular diseases, diabetes, acute and chronic renal failure, deep vein thrombosis, pulmonary embolism, peripheral vascular diseases, preeclampsia, eclampsia, seizure, convulsion, and cancers Without history of drug abuse or sedative & hypnotic drugs Without congenital malformation Without history of airway problems and systemic diseases, and preterm labor Without history of medication allergy Without coagulopathy Hemoglobin level above 10 g/dl Normal level of clotting time (CT), bleeding time (BT), prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR) Having at least two clinical visit with obstetrician and one blood test and 2 control sonography during pregnancy in pregnancy record Filling the informed consent form 18 years 40 years Female Use of sedative and hypnotic drugs before surgery Use of anticoagulants 48 hours before surgery With psychiatric disorders O75.82 Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section Treatment - Drugs Treatment - Drugs Intervention group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) plus 5 μg of Dexmedetomidine (Pfizer company, US) (total volume of 3.0 ml) Control group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) with half a milliliter of 0.9 % saline (Shahid Ghazi pharmaceutical company) (total volume of 3.0 ml) Hemodynamic parameters (heart rate and blood pressure). Timepoint: Before and 1, 5,15, 30 and 60 minute after surgery. Method of measurement: Vital-signs monitoring device. Maternal pain. Timepoint: Before and 1, 6, 12 and 24 hours after surgery. Method of measurement: Visual analogous scale. Neonatal APGAR. Timepoint: 1st and 5th minute after birth. Method of measurement: APGAR scale. Arterial blood gases. Timepoint: After birth. Method of measurement: Arterial blood gases analysis. Gorgan University of Medical Sciences Approved 2018-11-18 Ethics committee of Golestan University of Medical Sciences Hirkan Blvd., Beginning of Shastkola road, Falsafi Educational Campus of Golestan University of Medical Sciences, Gorgan town Gorgan Golestan Iran (Islamic Republic of)