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IRCT20180826040869N3 IRCT 2023-12-12 Mazandaran University of Medical Sciences Investigating the effect of memantine in preventing vasospasm in SAH patients with consciousness level 9-15 Investigating the effect of memantine in preventing vasospasm in SAH patients with consciousness level 9-15 2023-12-09 anticipated 88 Complete https://irct.ir/trial/74044 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The number of 30 patients diagnosed with subarachnoid hemorrhage was selected as available and by block randomization method One of two intervention groups (15 people) and placebo (15 people) will take place. For random arrangement of samples in blocks of Random Allocation software version 2 was used. In this software, the number of groups is 2 (1: intervention and 2: placebo), the number of samples is 30, the size of the blocks is equal, and the coding is a combination of letters and numbers and random put. The statistically significant level was also set at 0.05. Next, for random allocation from the SNOSE method was used This method is one of the common methods in hiding random allocation. In this method, the first sequence It is randomly created using the mentioned software, then based on the sample size of the study, a number of envelopes with wrappers aluminum (in order not to clarify the contents of the envelopes), preparation and each of the random sequences created (intervention group or Placebo) is recorded on a card and the cards are placed in the envelopes in order. in order to preserve The random sequence is also named on the outer surface of the envelopes in the same order as it was produced by the software take Finally, the lids of the envelopes are glued and placed in a box. At the time of registration Participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: The participants in this study were unaware of the type of drug received (memantine or placebo). For this purpose, memantine and placebo were prescribed to the patients on a daily basis with the same shape and size in both groups. Nurses who were responsible for providing medicine to patients during hospitalization were not aware of the type of medicine and the assigned group of each patient. The research associate of the project, who was responsible for collecting the signs and symptoms of the patients for the final review of the clinical results, was unaware of the assigned group of patients in order to minimize the bias in the study. Finally, the person analyzing the results of the study using coding was blinded to the type of treatment group. 3 vasospasm. Intervention 1: Intervention group: Memantine (manufactured by Subhan Co.) 10 mg (2 tablets of 5 mg), twice a day, for 7 days. Intervention 2: Control group: Plasboza, according to appearance characteristics, without active ingredients, twice a day for 7 days. 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 further information
public Misagh Shafizad
Amir Mazandrani Blvd, Sari
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 mi.shafizad@gmail.com Mazandaran University of Medical Sciences scientific Misagh Shafizad
Amir Mazandarani Blvd ,Sari
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 mi.shafizad@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Visit within the first 24 hours of the onset of symptoms Confirmation of subarachnoid hemorrhage by the plan's neurosurgeon (based on history, clinical findings and CT scan or brain MRI) Patients with consciousness level 9 to 15 Consent of the patient or her legal guardian (in case of consciousness disorder) to participate in the study 18 years no limit Both Lack of patient consent to participate in the study Patients with a history of SAH or cerebral infarction Patients diagnosed with hydrocephalus Patients with secondary cerebral hemorrhage History of allergy to memantine Kidney failure stage 4 or 5 based on Acute Kidney Injury Network criteria (27) Moderate to severe liver disease (Child-Pugh criteria, grade B and C) (28) Having a history of epilepsy History of dementia The patient has a history of taking memantine in the last 6 months of pregnancy or breastfeeding I67.848 Other cerebrovascular vasospasm and vasoconstriction Treatment - Drugs Placebo Intervention group: Memantine (manufactured by Subhan Co.) 10 mg (2 tablets of 5 mg), twice a day, for 7 days Control group: Plasboza, according to appearance characteristics, without active ingredients, twice a day for 7 days GCS. Timepoint: After surgery for 1 week. Method of measurement: Visual analog scale. Vasospasm. Timepoint: Before surgery and 1 week after surgery. Method of measurement: angiography. Mazandaran University of Medical Sciences Approved 2019-12-25 Ethics Committee in Organizational Research of Imam (RA) Sari Educational and Therapeutic Hospital Imam Hospital, Amirmazandarani boulevard Sari Mazandaran Iran (Islamic Republic of)