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TITLE / DESCRIPTION: SOP NUMBER:

SOP For Preparation and use of anaesthetic mixtures and in procedural CNH /OT/002
sedation Version 2.0

Applies to CNH HEAD/RESPONSIBLE PERSON: EFFECTIVE DATE:

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RUTH GICHUKI 20/02/2024

Next Review 19/02/2026

PROCEDURE CHANGE HISTORY:

Replaced Prepared by Reviewed by Approved by

Version
Name RUTH GICHUKI LAZARUS ROTICH LUIZA KISORIO
1.0
Signature
Date 19/02/2024 19/02/2024 19/02/2024
Location of Master Copy: Master File Date of discontinuation: 20/02/2024

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Version # Effective Date Description of Changes Revised by
1.0 20/02/2022 Layout, Training Log, Bibliography, Content RUTH GICHUKI

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Area of application
Operating Theater
Staff involved
 Anesthesiologist
 OT nurses
Objective / Purpose
To ensure the use and preparation of anesthetic mixtures in procedural sedation is effectively
utilized.
Relevant / Related documents
 Anaesthetic chart
Equipment/Supplies
Equipment
 Desk for record-keeping
 Lockable Shelves for filing
 Informed consent with anaesthetic chart

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 GUIDELINE PROCEDURE

1. Introduction
Sedation as a means to facilitate challenging or painful procedures, or as a safe, cost-
effective
and time-saving alternative to general anaesthesia, is a popular addition to modern medical
care.
These guidelines are compiled to ensure safe Procedural Sedation Analgesia (PSA) for
adult
patients. They are intended for use by all medical practitioners and their teams, who
participate
in sedation for diagnostic and therapeutic procedures, either painful or non-painful. They
apply to PSA before, during and after the procedure. The objective is to develop the
guidance
provided by the South African Society of Anaesthesiologists (SASA) published in 2015.
They are
not intended to substitute supervised clinical training, nor are they intended as a recipe for
the
administration of sedatives, dissociative agents, and analgesics. These guidelines are
designed
to be applicable to procedures performed in a variety of settings i.e. hospitals, freestanding
clinics, physician, dental, and other surgeries.
The guidelines are not applicable to:
• Patients requiring intensive care sedation.
• The prescription of sedation and analgesia for palliative care.
• Sedation and analgesia for use in the home setting.

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• Premedication for patients undergoing general anaesthesia.
• Night sedation.
• Analgesia during labour and delivery.
• Postoperative analgesia.
1.1 Evidence
The guidelines are based on existing consensus statements, expert opinion, professional
regulations and peer-reviewed published research studies and reports.
1.2 Objectives of procedural sedation and analgesia (PSA)
The objectives of procedural sedation and analgesia are to:
• Respect the rights of the patient at all times.
• Reduce the patient’s fear, anxiety and distress.
• Minimise physical discomfort and pain.
• Minimise psychological trauma.
• Pose minimal threat to the patient’s safety.
• Allow the procedure to be completed safely, reliably and effectively

• Maintain consciousness and patient cooperation.

• Maintain control of physiological parameters.
• Maintain a patent airway.
• Return the patient to a state in which safe discharge is possible.
Good sedation practice requires the use of pharmacological and non-pharmacological
methods to manage pain and anxiety. Most procedures require the use of local, regional, or
systemic analgesia. However, pharmacological methods alone do not negate the need for
good
communication skills and a sympathetic attitude. Patient reassurance at all times is crucial
for a
successful sedation technique.

1.3 Indications for sedation

PSA is standard practice in most countries, to facilitate the performance of various

diagnostic and therapeutic procedures. Procedures that do not require neuromuscular
blockade and
where pain can be controlled either locally or systemically, without compromising patient
safety, are suitable for a PSA technique. PSA is currently used by various disciplines, such
as

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cardiology, gynaecology, dentistry, gastroenterology, radiology, dermatology, plastic
surgery,
and emergency medicine. The decision to perform PSA should be made by the primary
clinician
and the patient, not the sedation practitioner, and is determined by:
• behavioural indicators (e.g. anxiety),
• procedural indicators, and
• treatment complexity.

1.4 Risks to patient safety

Publications have highlighted a lack of formal training as contributing to sedation-related
adverse events, and sedation training is supported by all international sedation guidelines.1
The
sedation practitioner must undergo theoretical training, as well as supervised clinical
training.
Regular update of knowledge is essential.
Although the procedure itself usually poses little risk to the patient, the addition of
sedation,
administering sedatives/analgesics/dissociative agents, may add to the risk. The use of
combination therapy may further increase the risk of adverse events. Respiratory
depression is
the most significant adverse event following administration of sedatives/analgesics,
therefore
the maintenance and protection of the airway is a crucial part of safe sedation practice.
During
sedation the patient is taken from maintaining his/her own airway to depending on the
sedation
practitioner to preserve the airway. A focused airway examination is therefore mandatory.

Sedation endpoints

The American Society of Anesthesiologists (ASA) defines three levels of sedation:4

2.1.1 Minimal sedation/anxiolysis
Minimal sedation/anxiolysis is a drug-induced state during which the patient responds
normally

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to verbal commands. This level is sometimes referred to as ‘changing the mood’ of the
patient.
Cognitive function and physical coordination may be impaired, but airway reflexes,
ventilatory
and cardiovascular functions are unaffected.

2.1.2 Moderate sedation/analgesia

Moderate sedation/analgesia is also termed “conscious sedation”. This is a drug-induced

depression of consciousness during which purposeful response to verbal commands (either
alone, or accompanied by light tactile stimulation) is maintained. Interventions are not
usually
required to maintain a patent airway, and spontaneous ventilation is adequate.
Cardiovascular
function is usually maintained.
There are societies which believe that dissociative sedation, i.e. using ketamine, should be
part
of the sedation continuum, falling between moderate and deep sedation/[Link]
African Journal of Anaesthesia and Analgesia 2020; 26(2)(Supplement 1):S1-75

2.1.3 Deep sedation/analgesia

Deep sedation/analgesia is a drug-induced depression of consciousness during which

patients cannot easily be roused, but may respond purposefully following repeated or
painful
stimulation. Reflex withdrawal from a painful stimulus is not considered to be a purposeful
response. Deep sedation/analgesia may be accompanied by clinically significant ventilatory
depression, assistance with maintaining a patent airway, and positive pressure ventilation.
Cardiovascular function is usually maintained. This level of sedation is termed Monitored
Anesthesia Care by some international sedation guidelines.
In South Africa, deep sedation and analgesia should only be performed by doctors trained,
and
with experience in the field of anaesthesia, in accordance with the Guidelines for Practice
issued
by SASA.

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Transitioning through the planes of sedation/analgesia results in increased depression of
the
cardiovascular and respiratory systems and an increase in the likelihood of adverse events.
The sedation practitioner must be able to recognise and manage such complications both
promptly and effectively.

2.1.4 General anaesthesia

A drug-induced loss of consciousness during which patients cannot be roused, even by

painful
stimulation. The ability to maintain independent ventilatory function is impaired. Patients
require assistance in maintaining a patent airway, and positive pressure ventilation may be
required, because of depression of spontaneous ventilation or a drug-induced depression of
neuromuscular function. Cardiovascular function may be impaired.
Guidance on the care of the patient under general anaesthesia is provided in the
publication
Guidelines for Practice issued by SASA, and is not addressed in this document.
The following statement by the American Society of Anesthesiologists (ASA) must be taken
into
consideration with every sedation procedure:
“Because sedation is a continuum, it is not always possible to predict how an individual
patient
will respond. Hence, practitioners intending to produce a given level of sedation should
be able to rescue patients whose level of sedation becomes deeper than initially intended.
Individuals administering Moderate Sedation/Analgesia (‘Conscious Sedation’) should be
able
to rescue patients who enter a state of Deep Sedation/Analgesia, whilst those administering
Deep Sedation/Analgesia should be able to rescue patients who enter a state of General
Anesthesia. Rescue of a patient from a deeper level of sedation than intended is an
intervention
by a practitioner proficient in airway management and advanced life support. The
qualified
practitioner corrects adverse physiological consequences of the deeper-than-intended level
S6Guidelines for the safe use of procedural sedation and analgesia for diagnostic and
therapeutic procedures in adults: 2020–2025
of sedation (i.e. hypoventilation, hypoxia and hypotension), and returns the patient to the

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originally intended level of sedation.”4
It must be remembered that the level of consciousness is independent of the route of
administration. Any level of PSA may be achieved via any route of administration.

Basic/standard sedation

Basic/standard sedation is induced by a single agent and not a combination of agents, for
example:
• oral, transmucosal or rectal drugs, e.g. benzodiazepines, or
• inhalation of nitrous oxide (N2 O) in oxygen, where the concentration of N2 O must not
exceed
50% in oxygen, or
• titrated intravenous doses of midazolam, to a maximum dose of 0.1 mg/kg.
NB. The use of propofol (or any anaesthetic induction agent) is by definition an advanced
sedation technique (see 2.5.2).
If the above drugs are used in combination, basic/standard sedation ceases, and the
sedation
technique is classified as an advanced sedation technique. When a standard sedation
technique
proves to be insufficient, the depth of sedation must not be advanced, unless the patient is
fasted and a dedicated sedation practitioner is employed.
Standard sedation techniques can include the use of concomitant simple analgesics, for
example paracetamol.
The Academy of Medical Royal Colleges acknowledge that systemic analgesia in the form
of
a short-acting opioid, e.g. fentanyl, may be required in some patients to facilitate
administration
of local anaesthesia. Midazolam should carefully be titrated once the full effect of the
opioid is
clear and subsequent doses of opioid should be avoided.5
2.5.2 Advanced sedation

Advanced sedation can be defined as sedation induced by any one of the following
techniques:
• any combination of drugs, administered via any route, or
• any sedation administered via the intravenous route, e.g. propofol, etomidate,

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dexmedetomidine (with the exception of titrated doses of midazolam to a maximum of
0.1 mg/kg), or
• any inhalational sedation (with the exception of N2 O used as the sole agent in a
concentration
of less than 50% in oxygen), or
• infusion techniques, i.e. target controlled infusions (TCI).
2.6 Failed sedation
Failed sedation is defined as the failure to achieve a desired level of sedation for the
procedure
to be completed safely, and such that the procedure has to be abandoned, or the need arises
to convert to general anaesthesia. Possible reasons for failed sedation include inadequate

Prolonged sedation

The aim to reduce costs and avoid long theatre waiting time has resulted in an escalation
in the demand for procedures to be performed outside the operating theatre. Frequently
these procedures are quite lengthy and may require the provision of moderate sedation
and analgesia, or even deep sedation. Sedation practitioners are increasingly faced with
decisions as to how long a patient can be kept safely under sedation outside the operating
theatre. Prolonged sedation for lengthy procedures may involve risks, and mechanisms
must
be instituted to ensure the safety of patients. Currently there is no guidance for sedation
practitioners regarding the definition of prolonged sedation. Sedation experts recommend
that any sedation procedure lasting more than four hours for procedures performed
outside
the hospital should be defined as prolonged sedation. Any procedure lasting longer than
four
hours is probably best staged into two different procedures, although this approach may
not
be practical. The recommendation for a procedure expected to last more than four hours is
to
perform the procedure under general anaesthesia in-hospital.

3. Environment and clinical setting

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Sedation practitioners must understand the limitations of working in the relative isolation
of
the out-of-hospital setting. The premises and supporting facilities where sedation is
performed,
must meet the requirements of safe sedation practice. Pre-procedure assessment and
selection
of patients will determine if the facility fulfils the requirements for each individual patient.
The
minimal required facilities, equipment and drugs for procedures to be performed outside
the
operating room, must include those detailed in Basic equipment and drugs for procedural
sedation and analgesia in adults (Appendix 1).
Treatment areas must be large enough to enable adequate access for the sedation team.
Furthermore, sedation should only be performed in an environment where staff, facilities,
equipment and drugs meet requirements to manage emergencies. There must be enough
room for managing medical emergencies. Resuscitation equipment must be available,
maintained and regularly checked, especially before the start of the procedure. The
equipment
must be in working order and the drugs within their expiry date. Records of the
maintenance
of equipment must be retained and be made available for formal inspections. All surgeries
are
expected to have filled oxygen cylinders with appropriate attachments, as well as access to
a
defibrillator in case the patient needs resuscitation. The clinical setting must permit access
for
emergency services and the transfer of the patient, if necessary. Irrespective of the setting,
the
sedation team should have access to an intensive care setting,

The recovery facility may be either a dedicated recovery area or the treatment area may be
used as such. Monitoring of patients must continue in the recovery area until patients have
recovered from the effects of sedation. The recovery area must be equipped to facilitate the
management of any sedation-related adverse events.
All providers of procedural sedation services are responsible to ensure that the sedation
facility

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in which care is delivered, is appropriate for the needs and safety of the sedation
practitioners,
patients, and staff and that it is in line with guidelines and standards of care. The practice
appraisal protocol (Appendix 2) serves as a benchmark for sedation practitioners to
determine
whether the location they work in, fulfils the requirements as set out in the guidelines.
The sedation practitioner, together with the owner of the premises, must also ensure that
the
premises are inspected and accredited by an independent recognised sedation authority.
The
focus should review the procedures, sedation techniques, and processes. Records of the
audit
process and outcomes must be maintained and be available for inspection. Regular audits
should be considered as a core requirement for sedation providers involved in patient care.
It
is recommended that the Society of Sedation Practitioners of South Africa (SOSPOSA), or
the
equivalent body be contacted for evaluation of the sedation facility.

4. Valid informed consent to sedation and analgesia for medical/dental

procedures
Valid, informed consent is a complex process. The GDC (General Dental Council, UK)
gives
valuable principles and standards for the dental team regarding consent for dental
procedures.6
It should be documented that appropriate consent was obtained from the patient, or a
responsible person (parent/guardian), according to local and international requirements.
Before the process can be completed, information about the sedation and procedure must
be
provided in a clear and understandable way. This should happen at an appropriate time in
order
for the patient to be able to digest the information and formulate questions. The discussion
should therefore, if possible, not occur immediately before the procedure or even on the
day of
the operation. It must never be obtained after administration of sedative and analgesic
drugs.

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The nature of the procedure to be performed may also not be changed after sedative and/or
analgesic drugs were administered to the patient.
Patients must understand the risks of sedation before consenting. Therefore, an
explanation of
the procedure, the proposed sedation technique and an explanation of the risks and
benefits
of the proposed technique should be explained. Patients must be aware of the possibility
that
the sedation may fail and that the procedure may have to be abandoned or performed
under
general anaesthesia at a later date.

Patient assessment
Appropriate selection of patients for sedation is the first step of safe sedation practice. Each
patient must specifically be assessed to determine his or her suitability for sedation outside
the operating room. While the operator has the privilege of evaluating the patient
beforehand,
most sedation practitioners only meet the patient on the day of the procedure. The sedation
practitioner should therefore assist and guide the operator in the evaluation of patients’
suitability for sedation. It may be helpful to provide some guidance in the form of written
notes
to assist the operator in this process. Inappropriate patient selection is a recurring factor in
sedation-related adverse events and poor outcomes.
Patient selection includes obtaining information from the patient as well as providing
information to the patient. Whenever possible, pre-assessment should include retrieval and
examination of previous records, i.e. medical, sedation, anaesthesia and surgical history.
The evaluation should include:
• A recent medical history questionnaire (Appendix 4). Details of previous sedations are
vital,
as previous failed attempts at sedation may indicate the need for general anaesthesia for
future procedures. Enquire about previous problems with airway management as part of
the
suitability check for out-of-hospital procedures.
• Special attention to the drug history of the patient:
◦ Chronic medication, e.g. antihypertensive drugs, anticoagulants, anti-diabetic drugs.
◦ Psychotropic drugs (e.g. sedatives, anxiolytics, antidepressants, antipsychotics, anti

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epileptics, and drugs used in the treatment of mania) may cause adverse drug reactions,
particularly when used in combination with opioids and local anaesthetic agents during
sedation.
◦ Recreational drugs, especially since the relaxation of legislation on the use of marijuana.

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Expected Outcome
To ensure effective use of anaesthesia and its dosage

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TRAINING LOG:
By signing this log is an acknowledgement that I have read and understood the attached
document
DATE NAME SIGNATURE

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