Efficacy of oral modafinil on accelerating consciousness recovery in adult patients with moderate to severe acute traumatic brain injury admitted to intensive care unit: a randomized double-blind clinical trial.

Abstract

Background: Traumatic Brain Injury (TBI) is a leading cause of hospitalization and disability in young and middle-aged adults. This study aims to survey the efficacy of oral modafinil, a low-side-effect central nervous system stimulant, in the enhancement of consciousness recovery in moderate to severe TBI patients in the ICUs of a referral trauma center.

Materials and methods: All ICU patients meeting inclusion criteria between April 2021 and April 2023 were screened. Eligible patients had a motor Glasgow Coma Score(GCS) of 4 or 5 and did not receive continuous intravenous sedatives within 24 h before screening. They were randomly assigned to receive 200mg of enteral modafinil or placebo daily for 7 days. Motor GCS and total GCS scores, ICU/hospital stay duration, mechanical ventilation requirement, tracheal tube removal time, and tracheostomy needs were recorded.

Results: Among the included 85 eligible patients, there was no significant difference between the modafinil and placebo groups in the median days between the intervention and the time of a 2-unit increase in total GCS (P = 0.25) or a 1-unit increase in motor GCS (P-value = 0.31). The group assignment also had no impact on the mean GCS (P-value = 0.533) and mean motor GCS (P-value = 0.167) over time. The only significant difference was in the proportion of patients with an increase in total GCS by 2 units, which was 54% for the modafinil vs. 32% for the placebo group (P-value = 0.04), and an increase in motor GCS by 1 unit, with 56% in the modafinil vs. 34% in the placebo group (P-value = 0.04).

Conclusion: The administration of modafinil appears to be safe and beneficial for patients with severe TBI during their stay in the ICU.