drugset / Trial / NCT07620912

Sedation vs No Sedation in Mechanically Ventilated COPD Patients

NCT07620912

Phase 2 Completed 100 enrolled Al-Azhar University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the safety and efficacy of no-sedation compared to daily interruption of sedation (DIS) in mechanically ventilated patients with chronic obstructive pulmonary disease (COPD). Mechanical ventilation is associated with discomfort, anxiety, and agitation, often requiring sedation. However, excessive sedation may worsen outcomes, especially in COPD patients with respiratory failure. This randomized controlled trial will include 100 adult COPD patients admitted to the respiratory ICU and requiring invasive mechanical ventilation. Patients will be randomly assigned into two groups: one managed with daily interruption of sedation and the other managed with a no-sedation protocol. The primary outcome is ventilator-free days, while secondary outcomes include ICU length of stay, complications, difficulty of weaning, and nursing workload.

Timeline

Start
2025-04-14
Primary completion
2026-04-07
Completion
2026-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule