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Nocturnal Dexmedetomidine for prevention of delirium in high risk patients admitted to ICU after non-cardiac surgery: a Randomised, Double-Blind, Placebo-Controlled Trial

Nocturnal Dexmedetomidine for prevention of delirium in high risk patients admitted to ICU after non-cardiac surgery: a Randomised, Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210217001
Enrollment
114
Registered
2021-02-17
Start date
2021-03-08
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postoperative delirium Delirium Dexmedetomidine Postoperative delirium Nocturnal dexmedetomidine

Interventions

All management is the same to the nocturnal dexmedetomidine group, except the change from nocturnal dexmedetomidine to equivalent milliliters per hour of the placebo is administered to the patients (i
Active Comparator No treatment,Experimental Drug
0.9% NaCl,Dexmedetomidine

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older undergoing non-cardiac surgery 2. Admitted to SICU immediately after surgery (before 6 PM on the day of surgery) 3. A predictive score of postoperative delirium of 115 or more 4. Expected to stay in SICU for more than 24 hours

Exclusion criteria

Exclusion criteria: 1. Unable to communicate in Thai 2. Preoperative history of schizophrenia, epilepsy, Parkinsonism, myasthenia gravis 3. Inability to communicate in the preoperative period (coma, profound dementia, or language barrier) 4. Admitted with a primary neurologic condition or injury 5. Known preoperative LVEF less than 30% 6. Sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second-degree or greater atrioventricular block without pacemaker 7. Child-Pugh class C 8. Serious renal dysfunction (undergoing dialysis before surgery) 9. Known allergies or anaphylaxis of dexmedetomidine, propofol, midazolam, haloperidol 10. Expected death within 48 hours after surgery 11. Inability to obtain informed consent 12. Pregnancy

Design outcomes

Primary

MeasureTime frame
Postoperative delirium 7 AM and 7 PM from postoperative day 1 to ICU discharge/ 7 days/ death Thai CAM-ICU

Secondary

MeasureTime frame
Bradycardia continuously throughout ICU admission ECG,Hypotension every hour NIBP or invasive arterial blood pressure,Episodes of nosocomial infection Review at ICU discharge Chart review,Duration of mechanical ventilation Review at ICU discharge Chart review,ICU length of stay Review at ICU discharge Chart review,Hospital length of stay Review at hospital discharge Chart review,In-hospital mortality Review at hospital discharge Chart review,amount of sedative and analgesic drugs Review at ICU discharge Chart review

Countries

Thailand

Contacts

Public ContactOnuma Chaiwat

Mahidol University

onuma.cha@mahidol.ac.th0843882104

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026