Phase 4
N=285
Dexmedetomidine and Delirium in Patients After Cardiac Surgery
Delirium · C.Surgical Procedure; Cardiac · Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT02267538 ↗Enrolled (actual)
285
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Incidence of Postoperative Delirium — 7; 11 Participants — p=0.341
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- dexmedetomidine hydrochloride for injection (Drug); 0.9% sodium chloride for injection (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Peking University First Hospital
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Postoperative Delirium |
7; 11 | 0.341 |
| SECONDARY Cognitive Function |
29; 29; 34; 34 | 0.830 |
| SECONDARY Incidence of Non-delirium Complications After Surgery |
3; 3; 42; 51; 15; 27 | 0.214 |
Summary
Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery. Its occurrence is associated with worse outcomes of patients, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. It is also associated with long-term cognitive decline and decreased quality of life. However, until recently, pharmacological interventions that can effectively prevent its occurrence are still limited. The purpose of this study is to investigate whether perioperative dexmedetomidine use can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.
Eligibility Criteria
Inclusion Criteria
Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery)
Exclusion Criteria
Patients will be excluded if they meet any of the following criteria:
- Refuse to participate;
- Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
- Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
- History of brain injury or neurosurgery;
- Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker;
- Severe hepatic dysfunction (Child-Pugh class C);
- Severe renal dysfunction (requirement of renal replacement therapy);
- Other conditions that are considered unsuitable for participation.
Data sourced from ClinicalTrials.gov (NCT02267538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.