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COMPLETED
NCT07620912
PHASE2

Sedation vs No Sedation in Mechanically Ventilated COPD Patients

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Official title: Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-04-14

Completion Date

2026-04-10

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

Midalozam

Midazolam will be given as needed in bolus doses if agitation occurs.

Locations (1)

Al-Azhar University Hospital, Assiut

Asyut, Egypt