Table 2 Approved recommendations

Indication

1

Before sedating medication is used, the indication must be defined and documented.

SIPC, SPHC

2

Sedating medication can be used to relieve symptoms that patients find distressing, such as anxiety and agitation, without intending to alter consciousness.

SIPC, SPHC

3

Sedating medication can be used to relieve insomnia, if experienced as distressing by the patient. In this context, a temporary and reversible change in consciousness is intended (RASS-PAL < 0)^a.

SIPC, SPHC

4

Sedating medication can be administered to prevent suffering during or upon termination of medical measures.

SIPC, SPHC

5

In the case of distressing symptoms which, despite all proportionate measures to relieve them (measures administered on expert level), have not been sufficiently alleviated and remain unbearable for the patient, intentional sedation is indicated.

SIPC, SPHC

6

In medical crisis situations, such as acute haemorrhage or acute obstruction of the respiratory tract, in addition to opioid treatment of possible dyspnoea, intentional - if necessary deep - sedation is indicated.

SIPC, SPHC

7

Existential suffering is not an indication for deep continuous sedation until death without prior temporary sedation.

SIPC, SPHC

8

In general, the maintenance of deep sedation until death is only indicated when it can be assumed - with almost complete certainty - that a reduction in the level of sedation would lead to unbearable suffering again.

SIPC, SPHC

9

The wish to die is not an indication for the administration of potentially sedating medication and therefore also not for intentional sedation.

SIPC, SPHC

10

The desire for sedation should result in an assessment whether intentional sedation is indicated.

SIPC, SPHC

Intent/ Purpose

11

Sedating medication should be administered for the purpose of relieving symptoms, relieving suffering, or preventing imminent suffering during or upon termination of medical measures.

SIPC, SPHC

12

Before and during intentional sedation, the team ensures that the suffering of the patient remains the central focus and that the sedating medication is not used for the purpose of reducing the burden on the family or the team.

SIPC, SPHC

13

Intentional sedation must not be administered to hasten the death of the patient.

SIPC, SPHC

14

Intentional sedation which results in a limitation of mobility, may (only) be administered without judicial authorisation if the prevention of leaving the place of residence is not the primary purpose but a side effect of the primary intended relief of suffering.

SIPC, SPHC

Decision-making

15

The decision to use intentional sedation will be made in accordance with the (presumed) will of the patient.

SIPC, SPHC

16

Before intentional sedation, the patient or their legal representative and the treatment team must determine who is involved in the decision-making process.

SIPC, SPHC

17

In the case of diseases in which severe respiratory distress and/or a haemorrhage can be expected (e.g. tumours of the head or neck, motor neurone disease, COPD, pulmonary fibrosis), the option of symptom-relieving intentional sedation should be discussed in advance with the patient or their legal representative.

This conversation should be documented in the patient’s record or health care planning documentation for the last phase of life.

SIPC, SPHC

18

The assessment of whether symptoms remain refractory and unbearable for the patient, despite all proportionate (expert delivered) measures to relieve symptoms, takes place during a multi-professional case conference. In cases of existential suffering, psychological and pastoral competencies should be included in the case conference.

SIPC, SPHC

19

In cases of ethical conflict, the decision-making process relating to whether or not intentional sedation is to be administered should be supported by ethics counselling/an ethics case conference. Ethics counselling/ethics case conferences must be transparently documented in the patient’s record.

SIPC, SPHC

20

If intentional sedation is initiated during acute episodes of symptom exacerbation, when multi-professional discussion of the case is not possible, then this must be retrospectively carried out as soon as possible to confirm or revise the course of treatment.

SIPC, SPHC

21

If the use of a medication results in an unwanted reduction in consciousness, then an adjustment to the medication (dose, substance) to reverse the reduction in consciousness is to be considered or a decision must be made promptly at a case conference as to whether intentional sedation is indicated and corresponds to the (presumed) will of the patient. Only then intentional sedation - using suitable medication - is deemed appropriate.

SIPC, SPHC

22

The decision-making process for intentional sedation, the parties involved in the decision-making process, and the results of the decisions must be transparently documented in the patient’s record.

SIPC, SPHC

Information/Consent

Preliminary remark

Consent must be given by the patient. If the patient is unable to provide consent, a legal representative should be consulted to determine the will of the patient.

23

Before intentional sedation, the patient or their legal representative will be informed of all relevant indications, intentions, effects, planned duration, adverse effects, risks, potential effects on length of life (both in regard to shortening or prolongation), possible course without sedation, and voluntary nature of consent to the sedation.

SIPC, SPHC

24

When using medication that is not specifically used for sedation but may cause sedation as a side effect, the patient or their legal representative will be informed of this risk.

SIPC, SPHC

25

The treatment team must involve the patient’s relatives in the process of providing information on the intentional sedation if this is the wish of the patient or their legal representative.

SIPC, SPHC

26

The patient, and with the patient’s consent, their relatives are to be informed that the patient’s ability to communicate during the use of sedating medication will be limited, especially in cases of intentional sedation. If the patient no longer possesses the capacity to consent, the legal representative of the patient should receive the necessary information.

SIPC, SPHC

27

To ensure the patient’s right to self-determination, after providing the relevant information and a suitable time window, the patient will be asked to consent to administration of intentional sedation (informed consent).

If the patient no longer possesses the capacity to consent, the legal representative of the patient should be asked to provide the necessary consent.

SIPC, SPHC

28

Before the administration of intentional sedation, decisions to be made during the period of (potential) incapacity to consent should be discussed with the patient (if the patient is unable to consent, then with the patient’s legal representative). The discussion covers aspects such as rituals, nursing measures, duration of sedation, targeted level of sedation, possible attempts to awaken the patient (including the possible foregoing of the same), the management of other medications, and (artificial) hydration and nutrition.

SIPC, SPHC

29

If intentional sedation is initiated during acute episodes of symptom exacerbation, and it is not possible to provide the necessary information, this should be provided as soon as possible, if necessary, by retrospectively informing the patient’s legal representative.

SIPC, SPHC

30

The information process and the type of information provided are to be transparently documented in the patient’s record.

SIPC, SPHC

Medication and types of sedation

31

When using sedating medication, the substance selection is based on the indication, intention, effect, and duration of the treatment and possible adverse effects.

SIPC, SPHC

32

Intentional sedation uses the lowest possible dose of the medication to achieve the level of sedation necessary to relieve the patient’s suffering. Therefore, the dose should always ensure that the patient’s suffering is reduced to a level tolerable for the patient and that the sedation level is no deeper than necessary.

SIPC, SPHC

33

Generally, on initiation a medication dose is chosen to achieve light to moderate sedation (RASS-PAL − 1 to -2) [26]. Subsequently, the dose is adjusted in accordance with the recommendation in 2).

SIPC, SPHC

34

In case of acute crisis (e.g. acute respiratory tract obstruction, severe haemorrhage), an initial medication dose to achieve a deep level of sedation (RASS-PAL ≤ -3)^a can be selected.

SIPC, SPHC

35

In the event of changes in respiratory activity (bradypnea, hypoventilation) during intentional sedation, it should be critically assessed whether these changes are due to the dying phase or the medication dose. If the medication dose is found to be the cause of the change in respiration, then a dose reduction adapted to the relief of suffering should be considered. If the reduction in respiratory activity is due to the dying phase, then no dose reduction is necessary.

SIPC, SPHC

36

Intentional sedation should initially be administered as temporary sedation and then re-evaluated after a predefined time period.

SIPC, SPHC

37

Intentional sedation in case of existential suffering is initially administered as temporary sedation for a predefined time period (up to a maximum of 24 h).

SIPC, SPHC

38

Benzodiazepines, e.g. midazolam, are suitable for intentional sedation. Generally, these medications are the first choice, especially for patients requiring a reduction in anxiety levels and/or anti-epileptic effects. In the case of delirium, they should only be administered in combination with antipsychotic medication.

SIPC, SPHC

39

Antipsychotics with sedating (secondary) effects, e.g. levomepromazine, are a suitable second choice medication for intentional sedation. They can be administered in combination with benzodiazepines in cases in which benzodiazepines alone are inadequate to achieve sufficient relief of suffering.

SIPC, SPHC

40

Propofol is suitable for intentional sedation in cases in which other types of medication have not resulted in sufficient relief of suffering.

SIPC

41

Propofol is not suitable for intentional sedation in the home care setting.

SPHC

42

Opioids are not suitable for use in intentional sedation. Increasing the dose of an existing opioid therapy is also not a suitable means of intentional sedation. During intentional sedation, opioid treatment to reduced pain levels and/or treat dyspnoea is continued and the dose is adjusted as needed to ensure relief of pain and/or dyspnoea.

SIPC, SPHC

Monitoring

43

During sedation, the situation is re-evaluated by the person administering treatment and the dose adjusted to ensure the suffering is relieved to an acceptable level and that the level of sedation is no more than that required to relief the suffering.

SIPC, SPHC

44

The criteria for regular re-evaluation of the overall situation are intensity of suffering (most important criterion), level of sedation, and adverse effects.

SIPC, SPHC

45

The person administering intentional sedation is expected to use the patient’s relatives as an important supplementary source of information during regular re-evaluation.

SIPC, SPHC

46

During intentional sedation, depending on the illness situation and the treatment goals, selected vital signs (e.g. respiratory rate, oxygen saturation, heart rate, and blood pressure) could additionally be monitored to ensure a stable clinical status of the patient within the framework of the agreed objectives and limits of treatment. Threshold values and corresponding consequences and reactions must be defined for monitored vital signs.

SIPC, SPHC

47

During deep sedation outside of the dying phase, appropriate (vital) signs and parameters should be monitored to ensure that shortening of life is avoided as far as possible.

SIPC, SPHC

48

The frequency of re-evaluation should be determined (and adjusted, as necessary) by the physician responsible for the intentional sedation, taking into consideration the planned type of sedation and the pharmacokinetic properties of the sedating medication. Differences between titration phase and maintenance phases have to be considered.

SIPC, SPHC

49

As far as possible, the intensity of suffering should be assessed by directly asking the patient or their relatives, as well as by clinical observation (e.g. facial expression, sounds like groaning and screaming, body language, movements, agitation, tachycardia, and sweating).

SIPC, SPHC

50

The depth intentional sedation is assessed based on reactions to being addressed and light, non-painful touching e.g. using RASS-PAL [26].

SIPC, SPHC

51

The results of the re-evaluation of intentional sedation and the resulting consequences must be transparently documented in the patient’s record.

SIPC, SPHC

Management of fluids and nutrition

52

The decision to administer artificial hydration and/or nutrition must be made before or during sedation if the patient will no longer be able to eat and drink sufficiently on their own.

SIPC, SPHC

53

The decision to determine whether the artificial administration of fluids and/or nutrition is indicated must be made separately from the decision on intentional sedation.

SIPC, SPHC

54

In the case of intentional sedation, any decision on artificial hydration and/or nutrition is made with the patient or the patient´s legal representative or based on the presumed will of the patient and taking into consideration possible advantages and burdens as a result of these measures with regard to the treatment goals (relief of suffering).

SIPC, SPHC

55

The decision relating to artificial hydration and/or nutrition during intentional sedation should be transparently documented in the patient’s record.

SIPC, SPHC

Continuing other measures

56

During intentional sedation, the patient will continue to be treated in the same dignified manner as before sedation. This includes addressing the patient (also in phases during which the patient is not conscious), announcing in advance actions that involve touching the patient, and adapting the surroundings to the given situation and, if necessary, in accordance with the previously discussed wishes of the patient.

SIPC, SPHC

57

All nursing and medical measures are to be regularly evaluated and orientated towards the well-being of the patient. The measures should be adjusted to the changing conditions during intentional sedation and in accordance with the stated or presumed will of the patient.

SIPC, SPHC

58

Measures to ensure symptom relief and patient well-being that were implemented before the intentional sedation are normally continued, regularly re-evaluated, and adjusted if necessary.

SIPC, SPHC

Support for relatives

59

With the consent of the patient, the relatives should be included from the beginning in the decision-making process related to intentional sedation.

SIPC, SPHC

60

With the consent of the patient, relatives will be regularly informed of the patient’s current clinical situation and the expected course throughout the intentional sedation.

SIPC, SPHC

61

The team offers support to the relatives regarding their emotional or spiritual needs resulting from the intentional sedation.

SIPC, SPHC

62

The relatives are advised and, if necessary, instructed on how to support the patient during the intentional sedation and remain close to them, e.g. by talking, touching, creating a comforting atmosphere for the patient (e.g. favourite music, smells, singing well-known songs, reading aloud) and, if desired - are involved in the nursing care (e.g. mouth care).

SIPC, SPHC

63

Before deep sedation, which is expected to continue until death, or sedation which may become deep continuous sedation, the patient and their relatives should be given the opportunity to say goodbye to one another if the situation allows it.

SIPC, SPHC

64

After the death of the patient, the relatives will be given the opportunity to talk to members of the treatment team to discuss any remaining doubts concerning the intentional sedation.

SIPC, SPHC

Team support

65

All team members must fully understand the indications and treatment objectives of intentional sedation. The necessary discussions can take place at team meetings or during case conferences.

SIPC, SPHC

66

The discussion of stressful situations relating to intentional sedation, e.g. a retrospective case review or conference, is recommended. The aim of these meetings is to discuss the factual and emotional challenges, help the team process stress, and continuously improve the care provided.

SIPC, SPHC