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IRCT20160208026447N2 IRCT 2021-04-07 Tehran University of Medical Sciences The Evaluation of the effect of Atropine administration on parturients' hemodynamics undergoing cesarean section under spinal anesthesia The Evaluation of the effect of preoperative(spinal Anesthesia) Atropine administration on maternal hemodynamics and PH of neonatal umbilical cord blood in parturients undergoing cesarean section under spinal anesthesia 2016-03-20 anticipated 80 Complete https://irct.ir/trial/32945 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this clinical trial, two groups, including intervention group (I) and placebo (P), were randomly assigned based on a table of even and odd random numbers (including a chain of 80 numbers) designed by a statistical consultant. At the time of the patient's entry into the operating room, based on the sequence of the even and odd random number chain, if it was an even number, the envelope containing a prepared atropine syringe delivered to the injector, and if it was an odd number, the envelope containing prepared normal saline delivered to the injector, Blinding description: Drugs and placebo are prepared in similar envelopes. Each drug envelope is given a code. Each patient is given a code as well. Patients receive an envelope in order of arrival. This envelope is returned on the day of surgery by an unrelated person. Only the analyzer knows which drug and patient belong to which group. Researchers and patients are unaware of the type of code and the content of the codes. 4 Hemodynamic changes after spinal anesthesia in elective cesarean section. Intervention 1: Intervention group: Administration of 10 microgram/kg atropine intravenously prior to performing spinal anesthesia. Intervention 2: Control group: administration of normal saline in equivalent volume of drug used in case group. Yes - There is a plan to make this available What will be shared: The results of the study will be published without any name. When: 1year To whom: The researcher and his supervisor ( professor) Conditions: In order to publish in medical journals, without any name of participants. Where to obtain: researcher and supervisor( professor) How to obtain: sending an appropriate written request to the supervisor Comments:
public Amirhossein Orandi
Keshavarz Blvd- Imam Khomeini Hospital Complex
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2828 horandi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr.Amirhossein Orandi
Imam Khomeini hospital, end of Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2828 horandi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Pregnant females 18 to 45 years old undergoing cesarean section under spinal anesthesia Pregnant females without cardiac or other systemic diseases Pregnant females who have filled written informed consent to perform spinal anesthesia 18 years 45 years Female disagreement in participating in study any history of cardiac diseases Prevention Placebo Intervention group: Administration of 10 microgram/kg atropine intravenously prior to performing spinal anesthesia. Control group: administration of normal saline in equivalent volume of drug used in case group Maternal hemodynamic parameters. Timepoint: After administering Atropine as premedication or normal saline as a placebo the maternal vital signs would be checked and recorded, thereafter spinal anesthesia will be provided, and after repositioning to the supine position the vital signs would be checked instantly and would be repeatedly checked every 3 minutes. After delivery, the Ph of neonatal umbilical cord blood sample would be checked instantly and will be recorded. Method of measurement: Vital signs monitoring system. Ph of umbilical cord blood sample. Timepoint: After administering Atropine as premedication or normal saline as a placebo the maternal vital signs would be checked and recorded, thereafter spinal anesthesia will be provided, and after repositioning to the supine position the vital signs would be checked instantly and would be repeatedly checked every 3 minutes. After delivery, the Ph of neonatal umbilical cord blood sample would be checked instantly and will be recorded. Method of measurement: Using Blood Gas Analysis. The number of drugs used during surgery. Timepoint: At the end of surgery. Method of measurement: the number of drugs used at the end of procedure. Tehran University of Medical Sciences Approved 2017-04-21 Ethics committee of Tehran University of Medical Sciences- Imam Khomeini Hospital Complex keshavarz boulvard- Imam Khomeini Hospital Complex Tehran Tehran Iran (Islamic Republic of)