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

Phase 2

Recruiting

• Conditions: Postoperative delirium; Delirium; Dexmedetomidine; Nocturnal dexmedetomidine

• Registration Number: TCTR20210217001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-17
• Study Completion: 2022-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 114

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative delirium 7 AM and 7 PM from postoperative day 1 to ICU discharge/ 7 days/ death Thai CAM-IC

Secondary Outcome Measures

Name	Time	Method
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