BIDMC Conscious Sedation Manual

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Beth Israel Deaconess Medical Center
BIDMC Manual
Title: Conscious Sedation (Non-Anesthetist Moderate Sedation)
Policy #: CP-03
Purpose:
 To establish one standard of care for administering and monitoring conscious
sedation for all patients throughout the medical center.
 To delineate the practice for the safe and effective administration of conscious
sedation (IVCS) in the absence of an anesthesia provider.
Procedure(s) for Implementation:
I.
AUTHORITY
 Authority for the application of the Beth Israel Deaconess Medical Center policy
resides with the Beth Israel Deaconess Medical Center Medical Executive
Committee.
 Privileging of operators and monitors is under the authority of the BIDMC
Medical Executive Committee. Individual practitioners and department leaders
are responsible for ensuring that those who provide conscious sedation are
privileged to do so.
 Appropriate Quality Improvement efforts and complications review will be
performed and reported to PCAC annually.
II.
INTENT
These guidelines are intended to address patients who receive moderate
sedation (see below) by non-anesthesiologists. The following populations are
excluded from this policy:
 Patients sedated by a qualified anesthesia provider.
 Intubated patients receiving intravenous conscious sedation (IVCS) for
diagnostic and therapeutic procedures.
 The care of the pediatric patient. (Neonatal sedation is discussed in the
policies of the Neonatal Intensive Care Unit).
III.
DEFINITIONS
Sedation progresses on a continuum. The following definitions illustrate that
continuum.
 Minimal sedation (anxiolysis)
A drug-induced state during which patients respond normally to verbal
commands. Although cognitive function and coordination may be
impaired, ventilatory and cardiovascular functions are unaffected;

CP-03
Moderate sedation/analgesia (“conscious sedation”)
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A drug-induced depression of consciousness during which patients
respond purposefully to verbal commands, either alone or accompanied
by light tactile stimulation. No interventions are required to maintain a
patent airway, and spontaneous ventilation is adequate. Cardiovascular
function is usually maintained.
IV.

Deep sedation/analgesia
A drug-induced depression of consciousness during which patients
cannot be easily aroused but respond purposefully following repeated or
painful stimulation. The ability to independently maintain ventilatory
function may be impaired. Patients may require assistance in
maintaining a patent airway and spontaneous ventilation may be
inadequate. Cardiovascular function is usually maintained.

General Anesthesia
Consists of general anesthesia and spinal or major regional anesthesia.
It does not include local anesthesia. General anesthesia is a druginduced loss of consciousness during which patients are not arousable,
even by painful stimulation. The ability to independently maintain
ventilatory function is often impaired. Patients often require assistance
in maintaining a patent airway, and positive pressure ventilation may be
required because of depressed spontaneous ventilation or drug-induced
depression of neuromuscular function. Cardiovascular function may be
impaired.
SEDATION RATING SCALE
In order to assess a patient’s response to sedative or analgesic use, the
following rating scale is applied:
The patient experiences:
0- No sedation, awake
S- Sleepy (normal to arouse)
1- Mild sedation (occasionally sleepy, easy to arouse, responds to verbal
stimuli)
2- Moderate sedation (frequently drowsy, responds to gentle shake)
3- Severe or deep sedation (somnolent, difficult to arouse, responds to
sternal rub)
4- Unresponsive
V.
PERSONNEL
 At least two clinicians (Operator and Monitor) privileged in IVCS shall be
present whenever IVCS is administered. Both of these two personnel will be
available to the patient from the time of sedative/analgesic medication
administration until recovery is judged adequate, or the care of the patient is
transferred to personnel performing recovery care.
CP-03
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 Operator
The physician who administers the conscious sedation must have clinical
privileges to perform IVCS. Privileging requires training in the safe use of
these drugs and appropriate “rescue training.” Documentation of training will
be maintained in the physician’s credentialing and reappointment file.
 Monitor
The monitor must also have privileges in IVCS. S/he must have knowledge and
experience in the use of oximetry, cardiac monitoring equipment and in the
recognition of cardiac arrhythmias. The Nurse Manager shall certify that the
nurse monitor is trained in the safe use of these drugs and appropriate rescue
training. Documentation of biannual training will be maintained in the nurse’s
educational record. During the administration of IVCS, the monitor should
have no other significant responsibilities.

When IVCS is administered by non-anesthetists without ACLS or ATLS
training, a physician with current training in advanced cardiac life support
should be readily available (i.e., in the same or contiguous building) in case of
medical complications and emergencies.

The means for notifying additional support services such as Respiratory
Therapy and for calling cardiac arrest pages should be clearly identified in
procedure/sedation areas.

When the patient has been identified as “high risk,” or when the procedure to
be carried out is particularly complex, a member of the anesthesia care team
should be present to assist with the procedure. In elective cases, this must be
scheduled with an anesthesiologist at least 24 hours in advance by requesting
an Anesthesia Consultation (ext. 7-3112).
VI.
TRAINING AND PRIVILEGING OF PERSONNEL:
 The training requirements below pertain to the administration of moderate
sedation. No specific training is required to administer minimal sedation
(anxiolysis). Only clinicians with privileges in Anesthesia may administer deep
sedation or general anesthesia.

CP-03
Training requirements for privileging in moderated sedation include education
in the safe use of sedation drugs, appropriate rescue training and evidence of
clinical experience. As with all Medical Center privileging, the individual
practitioner and relevant department leaders are responsible to ensure that
those who provide moderate sedation are appropriately trained. The training
must be completed at least every 2 years in accordance with the recredentialing requirements. When these training requirements are met,
privileges to administer Moderate Sedation may be requested.
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
Training in airway management will be accomplished every two years through
completion of ACLS, ATLS, CCMALS or BCLS certification. Those who provide
sedation to ASA III or IV patients must obtain ACLS or ATLS certification as
cardiovascular instability during sedation is more common among these
patients. As an alternative, airway management skills can be obtained through
training provided by the Department of Anesthesia and approved by the MEC.

Training in the safe use of these drugs shall be achieved through a course
offered by the Department of Anesthesia and Critical Care in the use of drugs
and monitoring modalities used during conscious sedation. Alternatively, the
videotape of this training may be viewed to fulfill the course requirements or an
on-line training module can be completed.
VII.

EQUIPMENT
The room where the procedure USING IVCS is scheduled to take place should
have adequate, uncluttered floor space to accommodate emergencies.

CP-03
The following monitoring and emergency resuscitation equipment should be
available and in good working order prior to beginning the procedure.
1.
An airway and a self-inflating positive-pressure oxygen delivery system
capable of delivering 100% oxygen at a 15 liter/minute flow rate for at
least 60 minutes must be available. Various appropriate bag and mask
sizes must be available.
2.
Supplemental oxygen source
3.
Nasal prongs and non-rebreathing or rebreathing oxygen masks
4.
A source of suction (portable or wall)
5.
An emergency cart or kit including the necessary drugs (including
appropriate reversal agents) and equipment to resuscitate an apneic or
unconscious patient and provide continuous support while that patient is
being transported to another area
6.
A pulse oximeter with an alarm
7.
A manual or automatic device for measuring blood pressure
8.
Cardiac monitor with alarm. The Board of Registration in Medicine
recommends the use of cardiac monitors for patients with an ASA
classification of III or greater or with a history of cardio-pulmonary
disease.
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9.
All equipment shall be inventoried and maintained on a regularly
scheduled basis, in conjunction with policies established by the
hospital’s Biomedical Engineering Department.
VIII.

INFORMED CONSENT
The informed consent for any short-term therapeutic, diagnostic or surgical
procedure
in which conscious sedation is to be administered should include the risks of
conscious sedation, benefits and alternative options.
IX.
PRE-PROCEDURE ASSESSMENT AND DOCUMENTATION
Prior to the procedure and the initiation of conscious sedation, it shall be
ascertained that the patient is an appropriate candidate for conscious sedation
utilizing the following criteria:
CP-03
1.
The patient’s state of consciousness and medical condition are
appropriate for the use of conscious sedation.
3.
Preparatory studies appropriate to the procedure and the patient have
been done, including a determination of the need for blood or blood
products or other additional diagnostic data.
3.
There is a sedation plan and order written by the physician with clinical
privileges to perform the procedure (or his designee), unless that
physician will be administering the medication him/herself.
4.
The patient has no known allergies or sensitivities to the prescribed
medication.
5.
The patient has been NPO for at least six hours prior to the planned
procedure except for clear liquids, which may be given up to two hours
before the procedure. Patients considered to be at risk for aspiration
may require a longer NPO period. Medications may be administered with
a sip of water. In cases of emergency, where the patient has not been
NPO, IVCS may be dangerous. It should either not be administered or
administered judiciously to avoid unconsciousness or suppression of
protective airway reflexes.
6.
The patient/guardian has been informed by the physician of the risks
and alternatives to sedation as a component of the planned procedure,
and documentation of the patient’s consent has been placed in the
patient’s record prior to the procedure.
7.
The patient has been instructed:
a.
In the concepts of conscious sedation and about the sedation
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b.
8.
A physical examination has been conducted which includes
assessing/measuring the patient’s:
a.
b.
c.
d.
e.
f.
g.
9.
planned for the procedure, and
To report any problems associated with the procedure or
conscious sedation (e.g., pain, tender site, itching, difficulty in
breathing) to the individual responsible for monitoring the patient.
Actual or estimated height and weight
Vital signs (baseline blood pressure; heart rate; respiratory rate,
pattern and quality)
Baseline oxygen saturation
Airway (i.e., an evaluation performed in anticipation of possible
intubation, e.g. checking condition of teeth; range of neck motion;
ability to open mouth)
Chest and cardiac status
General neurologic status (e.g., assessing mental status;
presence of stroke deficits) and
Physical status (ASA physical status category)
Health evaluation has been documented including:
a.
b.
c.
d.
e.
f.
Allergies and previous adverse drug reactions
Current medications
Diseases, disorders and abnormalities
Prior hospitalizations
Pertinent family history of diseases or disorders
Review of systems
10.
The patient has a functioning IV line or saline lock.
11.
The patient’s oxygen requirements are evaluated. The need for
administration of supplemental oxygen via nasal prongs should be
considered.
Patients who are over the age of 60 or who have a medical history
significant for heart, lung or kidney disease should be routinely given
supplemental oxygen unless specifically contraindicated.
12.
A rationale for sedation, sedative plan, and plan for post procedure care
are documented.
13.
Physician operator shall sign immediate preprocedure assessment and
include phone number or page ID.
Such an assessment may be abbreviated as appropriate in emergencies.
CP-03
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X.
MONITORING
The Board of Registration in Medicine recommends use of a standard real-time
form to be included in the medical record, in which the patient’s management
and monitoring during IVCS would be documented.
1.
2.
XI.
During the procedure the designated monitor shall record:
a.
Heart rate, respiratory rate, blood pressure, sedation score, pain
level. If the patient has been classified ASA III or greater, or has a
history of cardiopulmonary disease, heart rate, and rhythm should
be displayed continuously on a cardiac monitor. The oxygen
saturation should be continuously displayed and recorded at 5minute intervals.
b.
Medication given (route, site, time, drug, and dose), including
oxygen therapy in liters/minute and means of delivery (e.g., nasal
prongs).
c.
The patient’s head position should be checked frequently to
ensure a patent airway.
d.
If the patient becomes unstable during the procedure, appropriate
medical consultation should be sought immediately.
Following the procedure:
 The nurse in the post procedure area should continuously monitor
the patient, and document vital signs (heart rate, blood pressure,
respiratory rate, oxygen saturation, pain level) at 15-minute intervals
for a minimum of 30 minutes following the end of the procedure.
 Beyond this thirty minute period, and, if stable, the above parameters
should be monitored every 15 minutes until the patient has returned
to preprocedure condition, or is transferred to other personnel
performing recovery care.
 Functioning suction apparatus and capability for delivering more than
90% oxygen with bag and mask must be readily available in the post
procedure recovery area.
 The patient must be observed for a minimum of 30 minutes following
the procedure, and for two hours if reversal agents including
flumazenil or naloxone have been given to reverse
sedative/analgesics.
POST-PROCEDURE PATIENT CARE AND DISCHARGE PLANNING
1. Transfer to a nursing unit will only be permitted when the patient’s PAR
CP-03
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score is 8 or above or at baseline.
 Patient has stable vital signs (blood pressure, pulse, respiratory rate) and
oxygen saturation (Sa02).
 Patient’s swallow, cough, and gag reflexes are present as appropriate to
baseline.
 Patient is alert or appropriate to baseline.
 Patient’s activity level is at pre-sedation baseline.
2. Discharge to home will be permitted when the patient’s PADS score is 9 or
above or at baseline.
 Patient has stable vital signs.
 Patient can sit unaided if appropriate to baseline and procedure.
 Patient can walk with assistance if appropriate to baseline and
procedure.
 Nausea and dizziness are minimal.
 Hydration is adequate. Dressing/ procedure site have been checked if
applicable.
 Discharge order has been written by the physician, or readiness for
discharge has been determined by the RN using established criteria.
3.
For patients being discharged to return home, the following apply:
a.
The ambulatory care patient may not leave the premises unless
they are under the care of a competent adult.
b.
4.
Written patient instructions include an explanation of potential or
anticipated post sedation effects and limitations on activities and
behavior including dietary precautions. Patients should be
advised to refrain from operating heavy machinery, driving a car,
consuming alcohol, and making important decisions for 12 to 24
hours. A 24-hour emergency contact telephone number should be
provided.
If the patient is being transferred for further care within the facility,
standard criteria for inter-unit transfer should be met.
Vice President Sponsor: Ken Sands, MD, VP, Health Care Quality
Approved By:
 Medical Executive Committee: 5/26/04
Mary Anne Badaracco, MD
Chair, MEC
Requestor Name: Steven Pratt, MD
Date Original Approved: 10/01
CP-03
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Next Review Date: 05/01/07
Revised: 5/26/04
Eliminated:
References: See Conscious Sedation in the BIDMC Manual of Clinical Practice.
Changes made to this document must also be made in the Manual of Clinical
Practice.
CP-03
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