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Observational Study
. 2024 Dec 31;22(1):608.
doi: 10.1186/s12916-024-03829-7.

Assessment of the efficacy of palliative sedation in advanced cancer patients by evaluating discomfort levels: a prospective, international, multicenter observational study

Maaike Rijpstra  1   2 , Kris Vissers  3 , Alazne Belar  4   5 , Michael Van der Elst  6 , Séverine Marie Surges  7 , Claudio Adile  8 , Rocío Rojí  4   9 , Yasmine Grassi  8 , Ewald Bronkhorst  10 , Sebastiano Mercadante  8 , Lukas Radbruch  7 , Johan Menten  6 , Carlos Centeno  4   5   9 , Evelien Kuip  3 , Jeroen Hasselaar  11   3
Affiliations
Observational Study

Assessment of the efficacy of palliative sedation in advanced cancer patients by evaluating discomfort levels: a prospective, international, multicenter observational study

Maaike Rijpstra et al. BMC Med. .

Abstract

Background: Palliative sedation involves the intentional proportional lowering of the level of consciousness in patients with life-limiting disease who are experiencing refractory suffering. The efficacy of palliative sedation needs to be monitored to ensure patient comfort. The aim of this study was to evaluate the efficacy using discomfort levels combined with sedation/agitation levels.

Methods: In this prospective observational study, adult patients with advanced malignancies were recruited from hospice units, palliative care units, and hospital wards in five European countries. Health care professionals used proxy observations of discomfort levels (Discomfort Scale-Dementia of Alzheimer Type, range 0-27) and sedation/agitation levels (Richmond Agitation-Sedation Scale modified for palliative care inpatients), range - 5 to + 4) to evaluate the efficacy of palliative sedation.

Results: In 78 participants, discomfort levels were monitored during palliative sedation. The mean discomfort score before start was 9.4 points (95% CI 8.3-10.5), which showed a significant decrease of 6.0 points (95% CI 4.8-7.1) after start of sedation for the total sedation period. In the multivariable analysis, no significant factors influencing baseline discomfort levels were identified. The discomfort and depth of sedation scores were found to be positively correlated, with an r of 0.72 (95% CI 0.61-0.82). The internal consistency of the discomfort scale was good (0.83), but the "Noisy breathing" item was less informative of the total discomfort score.

Conclusions: The efficacy of palliative sedation can be evaluated by measuring discomfort levels combined with sedation/agitation levels. The measurement of discomfort levels might provide a more specific and detailed evaluation of adequate sedation.

Trial registration: This study is registered at ClinicalTrials.gov since January 22, 2021, registration number: NCT04719702.

Keywords: Advanced cancer; End-of-life care; Monitoring; Observational study; Palliative sedation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study has been approved by the Research Ethics Committee (REC) of the Radboud University Medical Centre in Nijmegen (ref.nr. 2019/6016, June 2020), the REC of the University Hospital Navarra in Pamplona (ref.nr.2020.044, June 2020), the REC of the Rheinische Friedrich-Wilhelm’s University in Bonn (ref.nr. 300/20, July 2020), the REC of the University Hospital of Palermo (ref.nr. 7/2020, July 2020), and the REC of the University Hospitals in Leuven (ref.nr.S64008, August 2020). Written informed consent was obtained before participation in the study, both in the participants and in the relatives and health care professionals for completing questionnaires. All methods were conducted in accordance with relevant guidelines and applicable regulations. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
a Effect of palliative sedation at discomfort levels (DS-DAT). PS, palliative sedation; DS-DAT, Discomfort Scale-Dementia Alzheimer Type. Measurement before start PS (n = 77): mean 9.4 points (95% CI 8.0; 10.9) Measurement within 6 h after start (n = 74): mean 3.8 points (95% CI 2.4; 5.3). b Effect of palliative sedation at sedation/agitation levels (RASS-PAL). PS, palliative sedation; RASS-PAL, Richmond Agitation-Sedation Scale modified for palliative care. Measurement before start PS (n = 77): mean 0.15 points (95% CI -0.27; 0.58); measurement within 6 h after start (n = 73): mean -2.69 points (95% CI -3.11; -2.27)
Fig. 2
Fig. 2
Effects of palliative sedation (PS) and other variables at discomfort levels. PS, palliative sedation; PCU, palliative care unit; 95% CI, 95% confidence interval. Model 1. Repeated measurements model: mean discomfort before start: 9.4 (95% CI 8.3–10.5). Model 2. Multivariable model: repeated measurements model corrected for gender (ref = female), setting PCU and Hospice (ref = Hospital), Age (ref = mean age 69 years), Form: Intermittent sedation (ref = Continuous), mean discomfort before start: 10.0 (95% CI 8.3–11.6)
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References

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