Clonidine at Low dosage postOperatively to Nocturnally Enhance Sleep
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
The University of Queensland
120 participants
May 8, 2019
Interventional
Conditions
Summary
Postoperative delirium is a common surgical complication associated with major long-term morbidity and mortality. No single pharmacological agent has been conclusively shown to reduce or prevent postoperative delirium, but recent trials with dexmedetomidine – a highly selective alpha2- adrenoreceptor agonist – have been promising. A low-dose infusion on the night of surgery appears to have a lasting effect at reducing delirium for the week post infusion, and improved both the quantity and quality of sleep. If these findings could be replicated with clonidine (the prototypical alpha2-adrenoreceptor agonist), this – and subsequent – studies could have substantial implications for future perioperative delirium risk management.
Eligibility
Inclusion Criteria2
- Post-operative elective surgical patients admitted to the RBWH Elective Surgery High Dependency Unit (ESHDU).
- ESHDU doctor (registrar or consultant) agrees to the subject’s participation.
Exclusion Criteria14
- Age less than 18 years.
- Pregnancy or breastfeeding.
- Patients admitted to ICU (instead of ESHDU).
- ICU research coordinators not be available for enrolment (e.g. after 20:00) or completion of study assessments (Saturday morning – i.e. Friday admissions).
- Patients who are expected to be discharged home directly from ESHDU the day after surgery.
- Patients who take clonidine as a regular medication prior to surgery.
- 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.
- Advanced dementia (in the premorbid state requiring professional nursing care)
- The patient has previously been enrolled in a clinical trial of a sedative, antipsychotic or anti-delirium medication during this admission.
- Severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of second or third degree.
- Known allergy to alpha2-agonists including clonidine or dexmedetomidine.
- End-stage kidney disease or use of dialysis (prior to or during current admission).
- 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).
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Interventions
Single intravenous infusion of clonidine hydrochloride at 0.3 mcg/kg/hr (up to a maximum dosing weight of 100 kg) from 20:00 on the evening of surgery until 06:00 the following morning (10 hours total). Subjects will be followed from admission to the high dependency unit until discharge from the high dependency unit.
Locations(1)
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ACTRN12619000669190