Investigating the effect of memantine in preventing vasospasm in SAH patients with consciousness level 9-15

Determining the effect of memantine in preventing vasospasm in SAH patients with consciousness level 9 to 15

This study is a double-blind, randomized clinical trial using the variable blocks method. In this study, the limited randomization method (according to the sample size) was used to generate a random sequence using the block method and the Random allocation software.

This study will be conducted as a clinical trial in Imam Khomeini Hospital, Sari, on patients referred with the diagnosis of subarachnoid hemorrhage (SAH) with level of consciousness 9 to 15. All patients who will enter the study will undergo a diagnostic CT scan and receive the usual treatment process. Patients will be randomly assigned during the study using random numbers in two control groups (Sham) and memantine group. This study will be double blind. A diagnostic CT scan will be performed on all patients enrolled in the study and the usual treatment process will begin for both groups. Also, the level of consciousness of the patients (GCS), signs and symptoms of the disease and assessment of behavioral disorders at the time of arrival and one week later, as well as the risk of vasospasm based on the Fisher scale at the time of arrival, will be evaluated by a neurosurgeon. The patient and the person examining the CT scan results will not know the type of medicine received.

Patients with SAH; Patients with consciousness level 9 to 15

Patients in the memantine group were treated double-blind with memantine (manufactured by Subhan company) 10 mg (2 tablets of 5 mg), twice a day, and the placebo group, treated with similar tablets in terms of appearance characteristics without the active ingredient, twice a day for 7 days are placed

Consciousness level of patients

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.

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.