Comparison of the efficacy of hypertonic saline 5% with mannitol 20% on cerebral edema in ischemic and hemorrhagic stroke patients: a randomized clinical trial

To compare of the efficacy of hypertonic saline 5% with mannitol 20% on cerebral edema in ischemic and hemorrhagic stroke patients

This is a Phase III randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.

This study will be conducted at the Besat Hospital in Hamadan city, involving 100 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not feasible in this trial.

Inclusion criteria: Age 18 to 80 years Stroke GCS score between 3 and 8 Systolic blood pressure greater than 90 mmHg Having at least one pupillary reaction Exclusion criteria: Anuria or creatinine higher than 2.5 Convulsions Hypoxia

Intervention group: Mannitol 20% first with a dose of 1.5 gr/kg, then 100 ml every 4 hours within 15 to 20 minutes and repeating it until the patient regains consciousness Control group: Hypertonic saline 5% with a dose of 3 to 5 ml/kg and the same dose every 6 hours within 15 to 20 minutes and repeating it until the patient regains consciousness

Primary outcome: Cerebral edema

In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.