Clonidine at Low dosage postOperatively to Nocturnally Enhance Sleep

Phase 2

Recruiting

• Conditions: Postoperative sleep disturbance; Postoperative delirium; Anaesthesiology - Anaesthetics; Neurological - Other neurological disorders; Surgery - Other surgery

• Registration Number: ACTRN12619000669190
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-06
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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.

10. Severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of second or third degree.

11. Known allergy to alpha2-agonists including clonidine or dexmedetomidine.

12. End-stage kidney disease or use of dialysis (prior to or during current admission).

13. Comorbidities that will prevent or interfere with sleep measurement via the FitBit Alta HR, i.e. disease or condition such that wearing the device is either not possible (e.g. bilateral amputee, burns, loss of skin, etc), or will not be effective due to abnormal limb movement (e.g. quadriplegia, severe motor neuron disease, etc).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total sleep time (hours) assessed using a FitBit Alta HR[Night of surgery]