Dexmedetomidine for Sedation in Patients Requiring Mechanical Ventilation is Associated With a Lower Incidence of Delirium

NCT07806188 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-6-16PD
• Study Type: observational
• Target: 412
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective cohort study will include 412 adults mechanically ventilated \>24 hours in intensive care unit in sohag university hospital between 2024 and 2026). Participants will be assigned to either, EGDS group ( equal to 208 ) or conventional sedation group (equal to 204 ). The main endpoint will be measured is the incidence of delirium in ICU , measured by the Confusion Assessment Method for the ICU (CAM-ICU). Secondary endpoints will be the number of the days free from ventilation at 28 days (VFDs), ICU length of stay (LOS) in the ICU, and the death during hospitalization.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• occurrence of delirium during the ICU admission

  main end point: occurrence of delirium during the ICU admission , defined as at least one positive CAM-ICU assessment.

  Within 12 hours of intubation

Secondary Outcomes (2)

• Number of Ventilator-free days (VFDs)

  6 months

• duration of ICU stay (LOS)

  6 months

Study Arms (2)

EGDS Group: Patients managed per the institutional EGDS protocol initiated within 12 hours of intuba

· EGDS Group: Patients managed per the institutional EGDS protocol initiated within 12 hours of intubation. The protocol mandated: a) Primary sedative: Dexmedetomidine infusion (loading dose optional, maintenance 0.2-1.5 µg/kg/hr). b) Goal: Target Richmond Agitation-Sedation Scale (RASS) score of 0 to -2. c) Adjunct Analgesia: Scheduled acetaminophen and opioid infusion (e.g., fentanyl) for pain control (CPOT target \<3). d) Protocol Deviations: Propofol was allowed as a rescue for refractory agitation (RASS \>+2) after optimizing analgesia

Conventional Sedation Group: Patients managed at the discretion of the treating intensivist without

Conventional Sedation Group: Patients managed at the discretion of the treating intensivist without a mandated protocol. This typically involved continuous infusions of propofol and/or midazolam, with or without dexmedetomidine, with variable RASS targets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

this retrospective observational trial was conducted in a 40-bed intensive care unit at sohag university hospital between January 2024, to ,march 2026. The Institutional Review Board granted approval for the trial protocol and informed consent was waived

You may qualify if:

• Consecutive adult patients aged 18 years or older who required invasive mechanical ventilation for more than 24 hours.

You may not qualify if:

• Neurological primary admission such as stroke or traumatic brain injury.
• Active seizures or alcohol withdrawal at admission.
• Prior dementia or severe cognitive impairment.
• Mechanical ventilation \<24 hours.
• Death within 48 hours of admission.
• Missing essential sedation or delirium data.

Sponsors & Collaborators

• Sohag University: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 8, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-08