Investigating the effect of modafinil, methylphenidate and aminophylline in weaning from mechanical ventilation in patients with acute traumatic brain injury.

Comparing the effects of modafinil, methylphenidate and aminophylline on the level of consciousness and weaning from mechanical ventilation in patients with acute traumatic brain injury in intensive care unit

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130719014056N14

Enrollment

189

Registered

2024-06-29

Start date

2024-08-25

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute traumatic brain injury.

Interventions

Intervention 1: Intervention group: Modafinil. Intervention 2: Intervention group: Methylphenidate. Intervention 3: Intervention group: Aminophylline.

Eligibility

Sex/Gender

All

Age

16 Years to 50 Years

Inclusion criteria

Inclusion criteria: GCS less than 10 Intubated Age between 16 and 50 years Both genders History of acute traumatic brain injury Absence of space-occupying lesion in brain CT scan (chronic hematoma, tumor) Absence of seizure history No addiction to psychoactive substances and narcotics No history of amphetamine use No history of hypertension, ischemic heart disease, diabetes mellitus, and liver and kidney disease Heart rate less than 120 times per minute Absence of sepsis or infection in any part of the body

Exclusion criteria

Exclusion criteria: Convulsions Arrhythmia Evidence of drug sensitivity Death Lack of consent of the patient to participate in the study

Design outcomes

Primary

Measure	Time frame
The time required to weaning patients from the ventilator, GCS on consecutive days 1 to 9 (odd days) and check the severity of the disease based on the Apachi II criteria on consecutive days 1 to 9 (odd days) . Timepoint: Consecutive days from 1 to 9 (odd days). Method of measurement: The criteria for Weaning the patient from the ventilator is based on the completion of the isolation criteria questionnaire, and the evaluation of GCS and Apachi II criteria is also based on the completion of the questionnaire.	—

Measure

Time frame

The time required to weaning patients from the ventilator, GCS on consecutive days 1 to 9 (odd days) and check the severity of the disease based on the Apachi II criteria on consecutive days 1 to 9 (odd days) . Timepoint: Consecutive days from 1 to 9 (odd days). Method of measurement: The criteria for Weaning the patient from the ventilator is based on the completion of the isolation criteria questionnaire, and the evaluation of GCS and Apachi II criteria is also based on the completion of the questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHesameddin Modir

Arak University of Medical Sciences

he_modir@arakmu.ac.ir+98 86 3313 9680

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026