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Clinical Trials/TCTR20210217001
TCTR20210217001
Recruiting
Phase 2

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

Faculty of Medicine Siriraj Hospital, Mahidol University0 sites114 target enrollmentFebruary 17, 2021
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ConditionsPostoperative deliriumDeliriumDexmedetomidineNocturnal dexmedetomidine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Postoperative delirium
Sponsor
Faculty of Medicine Siriraj Hospital, Mahidol University
Enrollment
114
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 17, 2021
End Date
March 1, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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