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IRCT20160307026950N39 IRCT 2022-01-13 Esfahan University of Medical Sciences The effect of Atropine-Neostigmine mixture and Ondansetron on headache after Cesarean section under spinal anesthesia Comparison of the effectiveness of Atropine-Neostigmine mixture and Ondansetron injection in preventing headache after Cesarean section under spinal anesthesia 2022-01-21 anticipated 60 Complete https://irct.ir/trial/55552 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs are placed in the desired number in sealed opaque and uniformly sealed bags. Each of the codes is also written on a piece of paper, folded, and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups, Blinding description: This is a double-blind clinical trial; In this way, before obtaining consent, patients are studied but do not know which group they will be in and therefore are blind. Also, the nurse who injects the drug and the researcher who records the patient's symptoms do not know the type of drug and are blind. 3 Headache after spinal anesthesia in cesarean. Intervention 1: Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive about 2cc/kg/hr serum 1/3-2/3 then 10µg/kg Atropine and 20µg/kg Neostigminr will be injected 15 minutes before the spinal. Then the patient will be positioned in a seating or lateral and spinal anesthesia will be performed. Then patients receive 4-6 liters of oxygen per minute through a face mask and after sensory and motor block surgery will perform. During the operation and in recovery, the patient is monitored for vital signs and related complications. Intervention 2: Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 2cc/kg/hr of 1/3-2/3 serum, then they are given 4 mg of Ondansetron 15 minutes before the spinal Is injected. Then the patient will be positioned in a seating or lateral and spinal anesthesia will be performed. Then patients receive 4-6 liters of oxygen per minute through a face mask and after sensory and motor block surgery will perform. During the operation and in recovery, the patient is monitored for vital signs and related complications. Intervention 3: Control group C: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 2cc/kg/hr of serum 1/3-2/3, then they are given 5 ml of distilled water as a placebo 15 minutes before Spinal injection is performed. Then patients receive 4-6 liters of oxygen per minute through a face mask and after sensory and motor block surgery will perform. During the operation and in recovery, the patient is monitored for vital signs and related complications. 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 There is no more information
public Behzad Nazemroaya
Ostandari
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3224 7233 b.nazemroaya@khuisf.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Ostandari
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3224 7233 b.nazemroaya@khuisf.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Pregnant woman candidate for cesarean section under spinal anesthesia Age 18 to 45 years ASA class I and II Patient consent to study 18 years 45 years Female Consumption of anticoagulants Existence of nerve damage in limbs, spine and CNS Having coagulation diseases History of spinal surgery, spinal stenosis and MS Having heart conduction disorders Have a history of migraine headaches O29 Complications of anesthesia during pregnancy Prevention Prevention Placebo Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive about 2cc/kg/hr serum 1/3-2/3 then 10µg/kg Atropine and 20µg/kg Neostigminr will be injected 15 minutes before the spinal. Then the patient will be positioned in a seating or lateral and spinal anesthesia will be performed. Then patients receive 4-6 liters of oxygen per minute through a face mask and after sensory and motor block surgery will perform. During the operation and in recovery, the patient is monitored for vital signs and related complications. Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 2cc/kg/hr of 1/3-2/3 serum, then they are given 4 mg of Ondansetron 15 minutes before the spinal Is injected. Then the patient will be positioned in a seating or lateral and spinal anesthesia will be performed. Then patients receive 4-6 liters of oxygen per minute through a face mask and after sensory and motor block surgery will perform. During the operation and in recovery, the patient is monitored for vital signs and related complications. Control group C: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 2cc/kg/hr of serum 1/3-2/3, then they are given 5 ml of distilled water as a placebo 15 minutes before Spinal injection is performed. Then patients receive 4-6 liters of oxygen per minute through a face mask and after sensory and motor block surgery will perform. During the operation and in recovery, the patient is monitored for vital signs and related complications. The headache after spinal anesthesia in Cesarean. Timepoint: Patients are followed up for headaches for up to seven days after the spinal block. In case of headache in the first 24 hours every 6 hours and then daily, its amount is measured by VAS scale. Method of measurement: VAS Pain Intensity Scale. Esfahan University of Medical Sciences Approved 2021-04-07 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)