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Dexmedetomidine versus Chlorpromazine for Patients in ICU with Hyperactive Delirium: A Single-Center, Prospective, Double-Blind, Randomized Controlled Trial

Dexmedetomidine versus Chlorpromazine for Patients in ICU with Hyperactive Delirium: A Single-Center, Prospective, Double-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114067
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Hyperactive Delirium

Interventions

Dexmedetomidine group:Dexmedetomidine, a maintenance infusion of 0.2-1.4 µg/kg/h was continued until 6:00 AM the next day after achieving the target sedation level.
Chlorpromazine group:Chlorpromazine, a maintenance infusion of 2-15mg/h was continued until 6:00 AM the next day after achieving the target sedation level.

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients were enrolled if they (1) were aged 18 years or older, and (2) were non-cardiac surgical patients admitted to the ICU who had a positive CAM-ICU assessment and a RASS score ranging from +1 to +4.

Exclusion criteria

Exclusion criteria: ?(1) History of severe dementia or language impairment?; ??(2) History of alcohol abuse?; ??(3) Known left ventricular ejection fraction (LVEF) < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or type II/III heart block without a pacemaker?; ??(4) Expected survival time < 24 hours?; ??(5) History of brain injury or neurosurgery?; ??(6) Pregnancy or lactation?; ??(7) Known contraindications to dexmedetomidine or chlorpromazine.

Design outcomes

Primary

MeasureTime frame
Delirium-free time within 5 days;

Secondary

MeasureTime frame
This study recorded ?the time to reach the target sedation depth? following drug administration.;Daily SOFA scores within 5 days after treatment;Evaluate the longitudinal changes in inflammatory factor levels after administration of the trial drug (measured on Days 1, 3, and 5) and to determine their correlation with the duration of delirium-free time during the study period.;Need for concomitant sedatives and antipsychotics during the ICU period?;Length of ICU stay and Post-ICU hospital stay;30-day all-cause mortality after surgery;

Countries

China

Contacts

Public ContactTong Wu

Huashan Hospital Fudan University

840500790@qq.com+86 183 0055 0602

Outcome results

None listed

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