2- Materials and methods:
2-1 Study design
This single-centre, prospective, randomized, single-blind, controlled clinical trial was conducted on 20 patients with TBI admitted to the neurosurgical ICU of Shahid Kamyab Hospital (Mashhad, Iran) from October 2018 to August 2019. The study was retrospectively registered in the Iranian Registry of Clinical Trials (IRCT; registry number: IRCT20180515039674N1). The study protocol (18) was approved by the Research Ethics Committee of Mashhad University of Medical Sciences, Mashhad, Iran (reference approval number: IR.MUMS.REC.1397.149).