Evidence map›Paper›PMID 39724479›Full record

Trial reportNeurosurgical review2024

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.

Z Zand, F Zand, N Asmarian, G Sabetian, M Masjedi, Z Beizavinejad, M Banifatemi, O Yousefi, R Taheri, A Niakan and 1 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Neurosurgical review, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Z ZandDepartment of Critical Care Medicine, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
F ZandDepartment of Critical Care Medicine, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
N AsmarianResearch Consultation Center, Shiraz University of Medical Sciences, Shiraz, Iran.
G SabetianTrauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Chamran Blvd, Shiraz, 7194815711, Iran.
M MasjediDepartment of Critical Care Medicine, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Z BeizavinejadEmtiaz Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
M BanifatemiDepartment of Critical Care Medicine, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
O YousefiDepartment of Neurosurgery, Trauma Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
R TaheriDepartment of Neurosurgery, Trauma Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
A NiakanTrauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Chamran Blvd, Shiraz, 7194815711, Iran.
H KhaliliTrauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Chamran Blvd, Shiraz, 7194815711, Iran. khalilih@yahoo.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTraumatic 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

methodsAll 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.

resultsAmong 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).

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

Indexed as

Brain Injuries, TraumaticIntensive Care UnitsModafinilAdministration, OralAdultAgedConsciousnessDouble-Blind MethodFemaleGlasgow Coma ScaleHumansMaleMiddle AgedRecovery of FunctionTreatment OutcomeWakefulness-Promoting AgentsModafinilWakefulness-Promoting AgentsConsciousnessIntensive Care UnitModafinilTraumatic Brain Injury

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.