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IRCT20210324050762N1 IRCT 2021-09-24 Esfahan University of Medical Sciences Effect of Neostigmine and Atropine on post dural puncture headache in spinal anesthesia in cesarean Effect of pre-administration with Neostigmine and Atropine on the occurrence of post dural puncture headache in patients undergoing spinal anesthesia in cesarean 2021-08-22 anticipated 62 Complete https://irct.ir/trial/57508 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 62 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: In this study, the drug combination of "neostigmine and atropine" and normal saline were prepared by the operating room nurse in the same volume and marked with labels A and B. It is then given daily to the researcher and will be administered accidentally for patients. Therefore, the patient and the researcher will not have any information about the two prescribed drugs. 3 Cesarean section. Intervention 1: Intervention group: All patients will undergo spinal block. After performing the spinal block and confirming its accuracy, patients will be prescribed a combination of 0.5 mg of neostigmine and 0.5 mg of atropine. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously. Intervention 2: Control group: All patients will undergo spinal block. After performing the spinal block and confirming its accuracy, normal saline will be prescribed to patients. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Lili Adineh Mehr
Anesthesiology Department, Al-Zahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 liliadineh@yahoo.com Esfahan University of Medical Sciences scientific Lili Adineh Mehr
Anesthesiology Department, Al-Zahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 liliadineh@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Pregnant woman candidate for cesarean section with spinal anesthesia American anesthesiologists association classification I and II Age 18-45 years No neurological deficit in limb, spinal cord and CNS No coagulation diseases No history of spinal cord surgery, spinal canal stenosis and MS Duration of surgery less than 2 hours No heart conductive disorder No history of migraine headaches No anticoagulant drug consumption Consent for spinal block Patient consent to participate in the study 18 years 45 years Female Spinal block failure Change in anesthesia method to general anesthesia Bleeding more than 20 cc/kg More than 3 punctures O82.9 Delivery by caesarean section, unspecified Treatment - Drugs Placebo Intervention group: All patients will undergo spinal block. After performing the spinal block and confirming its accuracy, patients will be prescribed a combination of 0.5 mg of neostigmine and 0.5 mg of atropine. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously. Control group: All patients will undergo spinal block. After performing the spinal block and confirming its accuracy, normal saline will be prescribed to patients. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously. Headache severity. Timepoint: From first day to five days after surgery. Method of measurement: Visual Analogue Scale (VAS). Duration of headache. Timepoint: From first day to five days after surgery. Method of measurement: Counting the number of days suffering from headache. sfahan University of Medical Sciences Approved 2020-11-24 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave, Azadi Square. Isfahan Isfehan Iran (Islamic Republic of)