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ACTIVE NOT RECRUITING
NCT03624595
NA

Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery

Sponsor: Dong-Xin Wang

View on ClinicalTrials.gov

Summary

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.

Official title: Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial

Key Details

Gender

All

Age Range

60 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

502

Start Date

2019-04-16

Completion Date

2025-08

Last Updated

2025-04-09

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery in the intensive care unit; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.

DRUG

Placebo

Placebo (normal saline) infusion is administered in the same rate for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.

Locations (2)

Beijing University First Hospital

Beijing, Beijing Municipality, China

Fuwai Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China