Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol

Abstract

Background Palliative sedation involves the intentional lowering of consciousness at the end of life. It can be initiated to relieve a patient’s burden caused by refractory symptoms at the end of life. The impact of palliative sedation needs to be clinically monitored to adjust the proper dose and regimen of sedative medication to ensure that patients are at ease and comfortable at the end of their lives. Although there is consensus among health care professionals and within guidelines that efficacy of palliative sedation needs to be closely monitored, there is no agreement about how, when, and by whom, this monitoring should be performed. The aim of this study is to evaluate the effects of palliative sedation by measuring the discomfort levels and sedation/agitation levels of the patients at regular timepoints. In addition, the clinical trajectories of those patients receiving palliative sedation will be monitored and recorded. Methods The study is an international prospective non-experimental observational multicentre study. Patients are recruited from in-patient palliative care settings in Belgium, Germany, Italy, Spain and the Netherlands. Adult patients with advanced cancer are monitored by using proxy observations of discomfort (DS-DAT) and depth of sedation/agitation levels (RASS-PAL) during palliative sedation. After the palliative sedation period, the care for the specific participant case is evaluated by one of the attending health care professionals and one relative via a questionnaire. Discussion This study will be the first international prospective multicenter study evaluating the clinical practice of palliative sedation including observations of discomfort levels and levels of sedation. It will provide valuable information about the practice of palliative sedation in European countries in terminally ill cancer patients. Results from this study will facilitate the formulation of recommendations for clinical practice on how to improve monitoring and comfort in patients receiving palliative sedation. Trial registration This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

Sedação Paliativa Em Pacientes Oncológicos Terminais Em Cuidados Paliativos: Uma Revisão De Literatura

“…A sedação intermitente é aquela que permite períodos de alerta do paciente; enquanto, a sedação contínua, diminui o nível de consciência permanentemente. Já a sedação superficial, mantém um nível consciência no qual o paciente ainda pode se comunicar; enquanto, na sedação profunda, o paciente mantém-se em estado de inconsciência (RIJPSTRA et al, 2023).…”

“…A sedação paliativa é a administração deliberada de fármacos sedativos para induzir diferentes graus de redução do nível de consciência em pacientes portadores de doenças progressivas e irreversíveis e que estejam em cuidados de fim de vida, com o intuito de aliviar sintomas intoleráveis e refratários (CARACENI et al, 2018). Considerase presente sintoma refratário quando: todas as medidas farmacológicas e não farmacológicas para controlá-lo foram ineficazes; ou todas as medidas farmacológicas e não farmacológicas para controlá-lo geraram efeitos adversos excessivos ou intoleráveis; ou após consenso de equipe não existem métodos para alívio do sintoma em um tempo tolerável (RIJPSTRA et al, 2023). Nesse aspecto, no fim da vida é muito comum os pacientes apresentam alguns sintomas sendo um deles, a dor; por isso, a analgesia se faz tão necessária associado à sedação paliativa (WON et al, 2019).…”