RecruitingPhase 2ACTRN12621001499875

Dexmedetomidine versus standard of care for the management of severe agitation in patients at end of life.

A randomized feasibility study comparing dexmedetomidine with standard of care drug therapy in the management of agitation patients with a palliative diagnosis in a hospice setting.

Sponsor

Dr Lana Ferguson

Enrollment

20 participants

Start Date

Dec 1, 2021

Study Type

Interventional

Conditions

Agitation

Summary

The purpose of this pilot study determine if dexmedetomidine provides more rapid control of all-cause agitation than standard of care (SOC) drug therapy for patients at end of life. The study hypothesis is that dexmedetomidine achieves more rapid and sustained control of all cause agitation than current SOC. While several overseas centres are using dexmedetomidine, there is currently no published randomised controlled trial evaluating the efficacy or superiority of dexmedetomidine over current SOC. The results of this and subsequent collaborative trials with NZ and overseas palliative care colleagues have the potential to significantly change the current management and SOC for patients with agitation in the palliative care setting, both in New Zealand and internationally.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

During the final stages of life, some patients experience severe agitation — a deeply distressing state of restlessness and anxiety — that is difficult to manage with standard medications. Dexmedetomidine is a sedative agent used in intensive care that may provide more rapid and sustained calm without causing the profound sedation that can prevent meaningful communication and dignity in dying. This pilot trial compares dexmedetomidine to the standard drug approach in palliative care patients experiencing severe agitation. This study aims to find out whether dexmedetomidine controls agitation faster and more reliably than current standard medications, and whether it is safe to use in this fragile population. Results from this and related studies could change how end-of-life agitation is managed in New Zealand and internationally, potentially bringing more comfort to patients and their families during a profoundly difficult time. This study is open to adults aged 18 or older who have a palliative diagnosis with a prognosis of 6 months or less, and who are experiencing significant agitation requiring medication to manage it. People with certain heart conditions (including AV block without a pacemaker, very slow heart rate, severe heart failure, or very low blood pressure) and those who do not speak English are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1 Dexmedetomidine infusion as per department guidelines (as per Waikato DHB Subcutaneous dexmedetomidine infusion guideline) starting at 0.4 mcg/kg/hr subcutaneously via continuous ambulatory del

Arm 1 Dexmedetomidine infusion as per department guidelines (as per Waikato DHB Subcutaneous dexmedetomidine infusion guideline) starting at 0.4 mcg/kg/hr subcutaneously via continuous ambulatory delivery device (CADD-solis) or Alaris infusion pump, titrated to acceptable symptom control. Titration to a maximum of 1.4mcg/kg/hr over a duration fo 72 hours (treatment may continue beyond 72 hours, but data will not be collected after this time point) Arm 2 Standard of care, which, for the purposes of this study, refers to the use of antipsychotic and/or benzodiazepine medication as per the treating clinician with reference to department guidelines Treatment Failure and Subsequent Management: Treatment failure is defined as the addition of, or change to, drug therapy different to the initial starting strategy. If agitation is not adequately controlled (i.e., RASS-PAL score of 0 to -2 is not achieved), the treating clinician can initiate other treatment as clinically appropriate, including treatment included in the other study arm. This would be deemed a failure of the original treatment arm. The patient will not be withdrawn from the study if treatment failure occurs, data on second-line therapy will continue to be collected. Assessment Tools: Agitation in the palliative care setting will be assessed using the Richmond-Agitation-Sedation Scale (RASS-PAL). This is a validated tool used to assess levels of agitation and sedation, modified for palliative care inpatients.. Use of the scale allows consistent measurement of sedation level in line with the aim to achieve a RASS-PAL score of </=0 in the management of problematic agitation. All patients will have appropriate care in other respects, as per the treating clinician, including: - Analgesia; - Attempts to reverse any underlying cause of agitation, if consistent with the patient’s goals of care (e.g., antibiotics for an infection causing agitation, if the patients accepts this); - Usual non-pharmacological management of agitation (e.g., low stimulus environment, safety partner if required). - Attention to pressure areas and elimination; - The patient’s usual medication, if consistent with their goals of care and remains appropriate to the clinical situation. Participants will be assessed routinely (nursing ratio maximum of 1:2), data will be collected as follows: In the first 24 hours after starting treatment, data collected will include: • hourly RASS-PAL assessment; • 4-hourly vital signs (if clinically appropriate); • adverse effects (modified-CTCAE); • bolus medications given (drug, dose, rationale, effect). Data collected from 24-72 hours will include: • 4-hourly RASS-PAL assessment; • adverse effects (modified-CTCAE); • bolus medications given (drug, dose, rationale, effect).