Dexmedetomidine 0.2 to 1.1 mcg/kg/hr by continuous subcutaneous infusion for up to 10 days

Midazolam 10 to 100 mcg/kg/hr by continuous subcutaneous infusion for up to 10 days

Pain Intractable

Delirium

Dyspnea

Nausea

Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.
The study drug will be started at a rate of 1.0 mL/hr.
The infusion rate is incremented by 0.5 ml/hr every 30 minutes until acceptable symptom control, bradycardia (heart rate < 40) or hypotension (systolic blood pressure < 80) prevent further increase or maximum infusion rate of 5.5 ml/hr, whichever comes first. Achievement of acceptable symptom control will be defined, for purposes of this trial, as a consensus between reports from patient, family care giver and attending registered nurse

Dexmedetomidine

Midazolam

Abbotsford Regional Hospital and Cancer Center

Pilot Study Comparing Treatment With Dexmedetomidine to Midazolam for Symptom Control in Advanced Cancer Patients

Dexmedetomidine Compared to Midazolam for Symptom Control in Advanced Cancer Patients: A Pilot Randomized Controlled Trial (RCT)

Sample size determination for significant improvement in:
Pain
Dyspnea
Nausea
Delirium
Rousability

Pain will be evaluated using the Edmonton Symptom Assessment Scale (ESASr)

Dyspnea will be evaluated using the Edmonton Symptom Assessment Scale (ESASr)

Nausea will be evaluated using the Edmonton Symptom Assessment Scale (ESASr)

Delirium will be assessed using the Delirium Rating Scale-Revised-98 (DRS-R-98)

Rousability will be measured using the Richmond Agitation and Sedation Scale (RASS)

Acceptable symptom control of the difficult to control or intractable symptoms of pain, dyspnea, nausea or delirium will be assessed by a two part question addressed to each of subject, family member and assigned palliative care nurse. Subjective responses will be collected from each as binary variables (0/1) with two positive responses indicating acceptable symptom control overall.

This information will be used to determine accrual rate. The accrual rate and the primary outcome measure of number needed to recruit will be used to determine the number of sites required for a multi-center double blind randomized controlled Phase III trial comparing dexmedetomidine to midazolam for symptom control in advanced cancer patients.

Fraser Health

Four component behavioral sleep intervention comprised of activity-rest, sleep-wake, phychological distress and symptom management. Four components of the Individual Sleep Promotion Plan are: stimulus control, sleep restruction, relaxation, and sleep hygiene.

Equal time and attention, information about healthy eating and general conversation

Breast Cancer

Four components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene

psychomotor agitation/kanceri i gjirit

Pilot Study Comparing Treatment With Dexmedetomidine to Midazolam for Symptom Control in Advanced Cancer Patients

Fatigue in Breast Cancer: A Behavioral Sleep Intervention

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