POLICY FOR THE USE OF CONSCIOUS SEDATION IN
PORTSMOUTH HOSPITALS NHS TRUST
Version
5
Name of responsible (ratifying) committee
Formulary and Medicines Group
Date ratified
17th January 2014
Document Manager (job title)
Matthew Wood. Consultant Anaesthetist
Date issued
31st January 2014
Review date
January 2016
Electronic location
Clinical Policies
Related Procedural Documents
See section 9 of this policy
Key Words (to aid with searching)
Sedation; Conscious sedation; Sedationists; Sedatives;
Drug administration; Patient monitoring; Risk
management; Training needs; Patients; Medical Staff
Version Tracking
Version
Date Ratified
4
14th January
2014
Brief Summary of Changes



The WHO checklist to be used in all cases
undergoing sedation
Monitoring of processes, training, complications
and patient satisfaction to be carried out by
department sedation leads
Transferred into new Trust template
Author
Matthew Wood
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust. Issue Number version 4 Issue
Date January 2014
(Review date: January 2016)
Page 1 of 9
CONTENTS
QUICK REFERENCE GUIDE
1.
2.
3.
4.
5.
6.
7.
8.
9.
3
INTRODUCTION
4
PURPOSE
4
SCOPE
4
DEFINITIONS
4
DUTIES AND RESPONSIBILITIES
5
PROCESS
5
TRAINING REQUIREMENTS
7
REFERENCES AND ASSOCIATED DOCUMENTATION
8
MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF PROCEDURAL
DOCUMENTS
9
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust .
Issue Date January 2014
(Review date: January 2016) Page 2 of 9
Issue Number version 4
QUICK REFERENCE GUIDE
1. Departments carrying out procedures under sedation should be aware of and follow this
policy.
2. Each department carrying out procedures under sedation should develop their own set of
local guidelines in line with Trust and national guidance.
3. There should be a named specialty consultant and consultant anaesthetist responsible for the
development, implementation and monitoring of the local sedation techniques and guidelines.
4. All staff involved in administering sedation should have undergone formal training in use of
sedation techniques, identification and management of the complications of those techniques.
5. Sedation should be administered by a dedicated, suitably trained member of the team who is
different from the clinician performing the procedure.
6.
Operator sedationists should only be responsible for patients undergoing defined procedures.
7.
Appropriate levels of monitoring defined by local guidelines should be available for all cases.
8.
Functioning resuscitation equipment and tilting trolleys should be available in all treatment
and recovery areas wherever sedation techniques are used.
9. The WHO checklist should be used in all cases where procedures are carried out.
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust .
Issue Date January 2014
(Review date: January 2016) Page 3 of 9
Issue Number version 4
1. INTRODUCTION
Several bodies have published guidelines for the provision of sedation services. Concerns have
been raised both nationally and locally, in the light of large national studies and local adverse
incident reports, about the safety of current practice that sometimes ignores guidelines and
recommendations. More recent recommendations made in NCEPOD (Scoping our Practice,
2004) report on endoscopy made explicit recommendations about training in sedation techniques.
This policy, an update of an original produced in 2002, describes how Portsmouth Hospitals NHS
Trust (PHT) will ensure the implementation of safe sedation practice in all clinical areas.
The latest version of this policy reflects the recent adoption of the WHO checklist (January 2009)1
and recent Rapid Response Reports from the National Patient Safety Agency regarding high
concentration preparations of Midazolam2.
2. PURPOSE
This policy has been written in response to Trust Risk Management Review systems and
Anaesthetic Morbidity and Mortality (M&M) meeting. These systems along with department Risk
Management Review systems will be used to monitor outcomes.
The purpose of the document is to set out the responsibilities of departments who carry our
procedures under sedation to ensure maximum patient safety undergoing such procedures.
3. SCOPE
This policy applies to all Portsmouth Hospitals NHS Trust departments and their staff using
sedation techniques.
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises
that it may not be possible to adhere to all aspects of this document. In such circumstances,
staff should take advice from their manager and all possible action must be taken to
maintain ongoing patient and staff safety’
4. DEFINITIONS
Conscious sedation
A technique in which the use of a drug or drugs produces a state of depression of the central
nervous system enabling treatment to be carried out, but during which verbal contact with the
patient is maintained throughout the period of sedation.
Deep sedation
A more profound depression of the central nervous system such that the patient is no longer able
to maintain verbal contact and may not be able to protect their airway.
General Anaesthesia
A temporary state of depression of the central nervous system, during which the subject is
unaware and unable to respond to their external environment, is unable to protect their airway
and may exhibit profound depression of the cardiac and respiratory systems.
Operator
A practitioner responsible for carrying out a diagnostic or therapeutic procedure
Operator Sedationist
Someone performing a diagnostic or therapeutic procedure while administering a sedation
technique on a patient.
1
WHO Surgical Safety Checklist. NPSA January 2009.
Rapid Response Report RRR011.-Reducing the risk of overdose with Midazolam injection in adults.
NPSA December 2008.
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust . Issue Number version 4
Issue Date January 2014
(Review date: January 2016) Page 4 of 9
2
Sedation techniques
Sedative drugs can be administered by inhalation, enteral (oral and sublingual) and parenteral
(intra-muscular and intravenous) routes. Benzodiazepines (midazolam, diazepam), intravenous
anaesthetics (propofol, ketamine) and opioids (fentanyl or pethidine) are the commonly used
agents.
5. DUTIES AND RESPONSIBILITIES
Elements of the process may be delegated to a suitably trained and qualified professional but
the ultimate responsibility for the quality of medical care lies with the Consultant responsible for
the patients.
Each department performing procedures requiring a sedation service should nominate a
consultant with explicit responsibility for establishing department guidelines for sedation. A
consultant anaesthetist will also be nominated to assist in this process.
The nominated clinicians should liaise to discuss common issues such as: assessment,
training, drug regimens, monitoring required, discharge criteria, monitoring of standards and
complications as well as operational implications.
The Trust will ensure provision of appropriate training opportunities in sedation practice to all
professionals involved.
The author of the policy has responsibility and authority to audit compliance with the Policy
among all departments.
6. PROCESS
ACTION
Assessment of all
patients should take
place before any
sedation technique
is contemplated.
Appropriate
sedation techniques
should be used
Operatorsedationists should
only be responsible
for patients
undergoing defined
procedures
RATIONALE
Establish need for sedation.
Identify:
 risk factors
 need for further investigations
 contra-indications or technical
difficulties of particular
sedation technique.
 Provide information to patient.
Some procedures are painful.
Most sedative drugs do not have
analgesic properties and
analgesics would be more
appropriate
Operators responsible for the
safe performance of a procedure
cannot administer, monitor or
treat the complications of
sedation in a timely manner
EVIDENCE
Reference4
POTENTIAL
RISKS/HARMS
Unnecessary use of
sedation.
Increased risk of
complications of
sedation techniques
Inadequate consent
acquired with risk of
litigation
Overdose of sedative
drugs to overcome
response to painful
stimulus causing cardiorespiratory depression
Delayed recognition and
treatment of
complications of
sedation by a distracted
operator may result in
cardiopulmonary
decompensation hypoxic
injury and death
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust .
Issue Date January 2014
(Review date: January 2016) Page 5 of 9
Issue Number version 4
Generally only one
sedative drug
should be used
according agreed
protocols defining
increments and
maximum doses.
The synergy of different types of
drug significantly reduce the
margin of safety between
conscious sedation and general
anaesthesia
Sedative and opioid
analgesic drugs
should be stored
and handled in line
with Trust Policy on
Controlled Drugs
Most of the drugs used in
sedation techniques are
controlled and there are legal
restrictions on their use and
storage
Correct low
concentration
solutions of
midazolam used
High concentration solutions of
Midazolam are reported by NPSA
to have lead to inadvertent
overdose with attendant
complications.
Each Department
should have a
Sedation Lead who
works with a named
Consultant
Anaesthetist
The two clinicians should develop
appropriate sedation regimens
and ensure training for all
members of the team providing
sedation
Sedationists should
have formal training
in sedation and
should only use
defined techniques
that they have
received training in.
Familiarity with a technique
optimizes safety.
Use of WHO
Checklist
The levels of
monitoring
equipment should
be defined
according to agreed
guidelines.
Because of the use of sedation
can obtund patients response the
use of the WHO Checklist can
contribute to ensuring that the
correct procedure on the correct
site is carried out and the team is
made aware of any patient
specific concerns.
Appropriate levels of monitoring
are needed for different patients
with varying levels of
dependency.
The state of anaesthesia
carries risk of death and
require greater levels of
support and intervention
Controlled
Drugs Policy
Reference2
Reference 4,5
Reference4
Failure to comply with
the Policy puts the Trust
at risk of prosecution
under the Misuse of
Drugs Act, 1971
Overdose of Midazolam
can cause complications
including respiratory
depression and death.
Lack of appropriate safe
sedation regimens for
the procedures carried
out in the department
that all staff are familiar
with.
Inadequate training of
staff in administration of
sedation and
management of the
complications
Increased risk of
complications, failure to
recognise complications
and inadequate
treatment of them puts
patients at risk.
Clinicians failing in their
professional
responsibilities and
makes Trust vulnerable
to litigation
Reference1
Reduced risk of incorrect
procedure being
performed and improved
patient safety
Reference3
Risk of failure to
recognise complications
of sedation technique.
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust .
Issue Date January 2014
(Review date: January 2016) Page 6 of 9
Issue Number version 4
Functioning
resuscitation
equipment, tilting
trolleys should be
available in
treatment and
recovery areas
whenever sedation
techniques are
used.
.
Resuscitation may be required at
any time during or after a
sedative technique is used.
Inadequate treatment of
complications of
sedation cause worse
outcomes.
7. TRAINING REQUIREMENTS
All members of the team involved providing sedation need to have knowledge of sedation
techniques and be aware of their role in the event of serious complications. Those members of
the team who are sedationists need further training in the provision, monitoring and treatment of
the complications of conscious sedation.
What will that training comprise?









Background to local and national regulations
Assessment of patients
Cardio-respiratory and neurological physiology
Clinical pharmacology
Applied Anatomy
Cannulation skills
Airway management skills
Function and limitations of monitoring equipment
Basic and advanced life support
OUTCOMES OF TRAINING
Teams working within the Trust offering a sedation service should be able to:
i.
ii.
iii.
iv.
v.
State the indications and contra-indications for the use of sedation techniques and methods of
assessment of patients
Describe the sedation techniques provided by the service
Define the number of staff and their skills, present during procedures carried out under
conscious sedation
Ensure staff administering the sedation techniques are appropriately and adequately trained
and describe how they will maintain their skills
Ensure systems are in place for monitoring of patients, record keeping, monitoring of the
outcomes of the use of sedation and demonstrate that local and national guidelines are being
followed
Who will deliver it?
Recognised ‘trainers’ within the Trust
Who will ensure those that need to have it have it?
The nominated clinician within each department will be responsible
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust .
Issue Date January 2014
(Review date: January 2016) Page 7 of 9
Issue Number version 4
8. REFERENCES AND ASSOCIATED DOCUMENTATION
1.
WHO Surgical Safety Checklist. NPSA January 2009.
2.
Rapid Response Report RRR011.-Reducing the risk of overdose with Midazolam
injection in adults. NPSA December 2008.
3.
Association of Anaesthetists of Great Britain and Ireland Recommendations for
Standards of Monitoring during Anaesthesia and Recovery. 4th Edition 2007
4.
UK Academy of Medical Royal Colleges and their Faculties-Implementing and
ensuring Safe Sedation Practice for healthcare procedures in adults-2002
5.
Academy of Medical Royal Colleges - Safe Sedation Practice for Healthcare
Procedures: Standards and Guidelines. October 2013
9. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably
practicable, the way we provide services to the public and the way we treat our staff reflects
their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
Our values are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They
are beliefs that manifest in the behaviours our employees display in the workplace.
Our Values were developed after listening to our staff. They bring the Trust closer to its vision
to be the best hospital, providing the best care by the best people and ensure that our patients
are at the centre of all we do.
We are committed to promoting a culture founded on these values which form the ‘heart’ of our
Trust:
Respect and dignity
Quality of care
Working together
No waste
This policy should be read and implemented with the Trust Values in mind at all times.
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust .
Issue Date January 2014
(Review date: January 2016) Page 8 of 9
Issue Number version 4
MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
The compliance with this policy will be responsibility of the Clinical Director of the specialty area.
Monitoring of compliance will be the responsibility of the author of the policy and will involve site visits and observational audits which will
occur annually. The key indicators of compliance (see table below) will include:




Identity of named clinician and anaesthetist responsible for the department guidelines for sedation.
Evidence of completed training by staff involved in the provision of sedation.
Evidence of collection of adverse incident reports and discussion at mortality and morbidity meetings.
Documentary evidence of outcomes including patient satisfaction.
Minimum requirement to
be monitored
Lead
Tool
Identity of named clinician
and anaesthetist responsible
for the department guidelines
for sedation.
Department
Sedation Lead
Evidence
of
completed
training by staff involved in
the provision of sedation.
Department
Sedation Lead
Self reporting tool
Biannual
Policy audit report to:

Trust Sedation Lead

Trust Clinical Governance
Group
Department Clinical Director
Evidence of collection of
adverse incident reports and
discussion at mortality and
morbidity meetings.
Department
Sedation Lead
Self reporting tool
Monthly
Policy audit report to:
•
Trust Sedation Lead
•
Trust Clinical Governance
Group
Department Clinical Director
Documentary evidence of
outcomes including patient
satisfaction.
Department
Sedation Lead
Patient satisfaction
survey
Annual
Policy audit report to:
•
Trust Sedation Lead
•
Trust Clinical Governance
Group
Department Clinical Director
Self reporting tool
Frequency of Report
of Compliance
Reporting arrangements
Annual
Policy audit report to:

Trust Sedation Lead

Lead(s) for acting on
Recommendations
Department Clinical Director
Trust Clinical Governance
Group
Reporting of these results will be to the Trust Governance Committee.
In the event of a major flu epidemic or major incident compliance with this policy may be difficult or impossible and will require a risk
assessment of the ability to provide safe sedation for procedures carried out by the department.
Policy for the Use of Conscious Sedation in Portsmouth Hospitals NHS Trust . Issue Number version 4
January 2016)Page 9 of 9
Issue Date January 2014
(Review date: