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Investigating the Neuroprotective Effects of Sedative Drugs in ICU

Comparative Investigation of Sodium Thiopental Infusion with Midazolam and Fentanyl Combination on S 100-B blood Level in Brain Trauma Patients under Mechanical Ventilation in ICU.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120430009593N17
Enrollment
85
Registered
2024-09-16
Start date
2019-01-30
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Traumatic Brain Injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Patients who underwent sodium thiopental infusion (Elixir Pharmaceutical) for 3 days after admission to the ICU, the initial loading dose of sodium thiopental was 3 mg/kg for 30 minute

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Brain trauma Patients Who Undergo Neurosurgery Requiring Post Operation Mechanical Ventilation in ICU ASA1,2 Stable Hemodynamic

Exclusion criteria

Exclusion criteria: Concurrent Trauma Allergy to Midazolam, Fentanyl, Thiopental Systemic Infections

Design outcomes

Primary

MeasureTime frame
Plasma Level of S100B in Both Groups. Timepoint: Base, Third Day and Fifth Day. Method of measurement: ELIZA Measuring Kit(DiaMetra, UK).

Secondary

MeasureTime frame
Determining the Duration of Dependence on Mechanical Ventilation in the Group under Thiopental Infusion. Timepoint: Daily. Method of measurement: Patient Extubation Time Based on Clinical and Laboratory Criteria.;Determining the Duration of Dependence on Mechanical Ventilation in the Group under Fentanyl and Midazolam Infusion. Timepoint: Daily. Method of measurement: Patient Extubation Time Based on Clinical and Laboratory Criteria.;Determining the Length of Stay in ICU in the Group under Fentanyl and Midazolam Infusion. Timepoint: Daily. Method of measurement: The number of Days the Patient Stays in the ICU.;Determining the Length of Stay in ICU in the Ggroup under Sodium Thiopental infusion. Timepoint: Daily. Method of measurement: The number of Days the Patient Stays in the ICU.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Memary

Shahid Beheshti University of Medical Sciences

drmemary@gmail.com+98 21 7743 7580

Outcome results

None listed

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