ACTRN12619000669190
Recruiting
Phase 2
A randomised, double-blind, single-centre, placebo-controlled trial of low-dose clonidine infusion to improve sleep in postoperative patients in the High Dependency Unit
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Postoperative sleep disturbance
- Sponsor
- The University of Queensland
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Post\-operative elective surgical patients admitted to the RBWH Elective Surgery High Dependency Unit (ESHDU).
- •2\. ESHDU doctor (registrar or consultant) agrees to the subject’s participation.
Exclusion Criteria
- •1\. Age less than 18 years.
- •2\. Pregnancy or breastfeeding.
- •3\. Patients admitted to ICU (instead of ESHDU).
- •4\. ICU research coordinators not be available for enrolment (e.g. after 20:00\) or completion of study assessments (Saturday morning – i.e. Friday admissions).
- •5\. Patients who are expected to be discharged home directly from ESHDU the day after surgery.
- •6\. Patients who take clonidine as a regular medication prior to surgery.
- •7\. Patients prescribed an a2 agonist (e.g. clonidine or dexmedetomidine) during the current admission (e.g. as premedication, perioperatively as an adjunct to anaesthesia, or as a PCA/PCEA adjunct)... except:
- •\* IV or oral clonidine up to maximum total dose of 1 mcg/kg administered either intraoperatively or in the Post Anaesthesia Care Unit will be permitted.
- •8\. Advanced dementia (in the premorbid state requiring professional nursing care)
- •9\. The patient has previously been enrolled in a clinical trial of a sedative, antipsychotic or anti\-delirium medication during this admission.
Outcomes
Primary Outcomes
Not specified
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