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).