Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
PURPOSE AND GOALS
In procedural sedation, the goals are to:
1) maintain safety throughout the intervention
2) minimize pain and/or anxiety, and
3) facilitate the procedure or the investigation.
The patient must be able to respond rationally to commands and to maintain his/her own
airway. The ability to maintain a patent airway is not only dependent on the amount of
sedation given, but is also impacted by the patient’s underlying medical problems,
debilitation, and body habitus. Every physician must thoroughly evaluate these critical
factors prior to a sedation procedure. Deep sedation is not to be provided under any
circumstance by a physician who is only credentialed to deliver procedural sedation.
These guidelines are not intended to manage patients with other known medical
conditions (such as pain management patients, patient with seizure disorders, patients in
labor and/or patients being managed by an anesthesiologist. When procedural sedation is
used, it is crucial to understand and appreciate the different levels of sedation and general
anesthesia:
DEFINITIONS
Light Sedation/Anxiolytic: Route of medication can be oral, intramuscular (IM) or
intravenous (IV). These patients are basically awake. There is essentially no anesthesia.
Amnesia may or may not be present. All bodily functions are normal and their protective
reflexes are intact.
Procedural Sedation (previous terminology, Conscious Sedation): A minimal level of
depressed consciousness that retains the patient’s ability to maintain a patent airway
independently. The patient would be able to respond spontaneously to physical and
verbal stimuli. The drug and the dosage are not intended to produce loss of
consciousness. An ideal level of sedation is when one achieves the clinical presentation
of the patient’s slurring of speech.
Deep Sedation: A controlled state of depressed consciousness or unconsciousness from
which the patient is not easily aroused and is unable to respond purposefully to physical
stimuli or verbal commands. This may be accompanied by partial or complete loss of
protective airway reflexes and the patient’s inability to maintain a patent airway
independently.
General Anesthesia: A controlled state of unconsciousness accompanied by a loss of
protective reflexes, including loss of the ability to maintain a patent airway independently
or to respond purposefully to physical stimulation or verbal command.
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
GUIDELINES
1. Patient Education and Participation
Staff will educate patients about treatment or diagnostic procedures, including
moderate sedation expectations so they can participate in their care plans to determine
appropriate use of sedation and analgesia and promote best patient outcomes.
2. Personnel:
A. The practitioner supervising the administration of drugs for procedural
sedation shall be appropriately trained in the following:
1) Airway management including: positioning of the airway, use of a oral
pharyngeal airway, application of positive pressure ventilation with a bag
and mask
2) Safe use of drugs with recognition of their effects with patient variability
3) Basic arrhythmia recognition course
B. The practitioner (nurse) will complete competencies as defined and monitored
by each department.
C. The practitioner (nurse) monitoring the patient shall have no other assigned
duties while the patient is under procedural sedation.
2. Quality Monitoring:
A. The Department of Anesthesiology will monitor and evaluate procedural
sedation practices throughout the hospital to promote uniform standard of
care. The Anesthesia Department will review, on and on-going basis, cases
that are identified by the Procedural Sedation Indicators.
B. Procedural Sedation Indicators are defined as the following:
1) Cardiopulmonary arrest
2) Unanticipated admission to the hospital or the ICU
3) Use of Narcan or Romazicon
4) Oxygen saturation less that 90% despite supplemental oxygen
5) Respiratory rate less than 8 per minutes for duration of greater than five
minutes
6) Any patient requiring any assisted ventilation.
3. Comprehensive Patient Assessment:
Each patient should be assessed prior to a procedure. Assessment should include:
1) History and a physical
2) Medications
3) Allergies
4) Adverse reaction with prior anesthesia
5) Vital signs
6) NPO status
7) Proper consent signed
8) ASA classification (See ASA Classification Table.)
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
American Society of Anesthesiology Patient Classification Table
Class
Description
ASA I
Healthy patient without problems
ASA II
Mild systemic disease or conditions that need to be treated
Examples: Diabetes Mellitus, smoking, asthma, thyroid
disease.
ASA III
Severe systemic diseases that limit activity but are not
incapacitating
Examples: Complicated or uncontrolled Diabetes Mellitus,
uncontrolled hypertension, coronary artery disease (CAD),
chronic obstructive pulmonary disease (COPD), cardiovascular
vascular accident (CVA).
ASA IV
Severe systemic disease that is incapacitating and is a constant
threat to life
Examples: Severe CAD, congestive heart failure (CHF), end
stage renal disease (ESRD), and steroid-dependent COPD.
ASA V
A moribund patient not expected to survive 24 hours with or
without intervention.
“E”
Added category if any of the above categories are an
emergency
4. Airway assessment
A. Each patient must be assessed for potential airway complications prior to any
procedural sedation.
B. A Mallampati airway classification assessment must be documented.
The Mallampati classification relates tongue size to pharyngeal size. The test is
performed with the patient in the sitting position, the head held in a neutral
position, the mouth wide open, and the tongue protruding to the maximum. The
subsequent classification is assigned based upon the pharyngeal structures that are
visible.
1) Look at the size of the tongue relative to the size of the oral cavity. If the
tongue obscures much of the pharynx, the patient is more likely to obstruct
under sedation.
2) Sit the patient upright and ask him or her to open their mouth as widely as
possible and protrude their tongue. A good Mallampati airway assessment
can be obtained without patients saying, AAAAAHH!
A difficult airway may be recognized on a very gross and obvious level.
However the potential difficult airway may be very subtle and requires careful
examination. The basis of a difficult airway are numerous and are only briefly
discussed here. Extreme caution (especially in selection of sedation level) is
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
required for the patient that presents with any of these conditions, especially if the
patient is in the lateral or prone position.
Mallampati Classification
Class I
Class II
Class III
Class IV
Visualization of the soft palate, fauces, uvula, anterior and posterior pillars
Visualization of the soft palate, fauces, and uvula
Visualization of the soft palate, and the base of the uvula
Soft palate is not visible at all.
The classification assigned by the clinician may vary if the patient is in the supine
(instead of sitting) position. If the patients phonates, this will falsely improve the view.
If the patient arches his or her tongue, the uvula will be falsely obscured. A Class I view
suggests ease of intubation (correlates laryngoscopic view, grade I) with a 99-100%
occurrence rate. Class IV view (correlates a poor laryngoscopic view, grade III or IV)
with a 100% occurrence rate. Beware of the intermediate Classes which may result in all
degrees of difficulty in laryngoscopic visualization.
5. Clinical Considerations and Interventions
If a patient has a small mouth, receding chin, and a short or immobile neck, management
of the airway could be difficult. These patients should be kept extremely light. It is
essential to constantly monitor these patients who have been given sedation. Be alert for
problems with ventilation and be cognizant of the fact that restlessness can be sign of
excessive sedation, as well as inadequate sedation. If the patient is breathing but the
oxygen saturation falls, it may only be necessary to stimulate the patient and instruct
him/her to take a deep breath. Hold sedation until saturation rises. Varying degrees of
stimulation during the procedure will result in comparable patient response. During the
periods of relative low level of stimulation, the patient can become more somnolent.
If the patient has some discomfort, it will be important to distinguish between pain and
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
pressure. The administered intravenous anesthetic provides some pain relief, but it
cannot be totally relied upon for complete analgesia. Pain should be controlled by local
anesthetic administered by the surgeon. Narcotic analgesics can cause some degree of
respiratory depression and must be given judiciously.
If the patient's airway becomes obstructed during sedation, the chin should be lifted until
the tongue is lifts up from the pharynx allowing air to pass at the base of the tongue. If
the patient does not breathe with the now open airway, an Ambu bag must be used to
provide positive pressure ventilation until spontaneous ventilation returns. It is very
important to maintain an open airway with chin lift/jaw thrust and maintaining a tight fit
with the mask for ventilation.
Complications of procedural sedation can occur as with general anesthesia (including
cardiac arrest, pulmonary arrest, drop in blood pressure, aspiration, arrhythmia, allergic
reaction or shock). In the event, that the patient stops breathing and does not respond
to stimulus (such as: turning the patient supine, surgical stimuli, jaw thrust or chin
lift), a Code Blue must be called.
PROCEDURAL REQUIREMENTS
1. Practitioner/Nurse (with no other assigned duties) will continuously monitor and
assess the patient under procedural sedations and will record (every 15 minutes or
more frequently if needed) the following and communicate any abnormal conditions
immediately:
A. Blood pressure
B. Heart rate
C. Pulse oximetry
D. Respiratory rate
E. EKG
F. Level of consciousness (Note: A patient starting to slur speech is an indication of
ideal level of procedural sedation.)
G. Temperature (for procedures lasting more than one hour).
2. Physician must be present or “immediately” available for any procedural sedation that
involves the administration of a controlled substance.
3. All medication being used must be properly labeled, handled, stored, and documented
when administered.
4. In accordance with the hospital policy, all patients having procedural sedation must
have intravenous access. (The only exception would be in the pediatric or ER
population.)
5. Medication must be administered according to State statutes (given by a physician or
a registered nurse).
6. Supplemental oxygen is required for patients with saturation levels less than 90% on
room air. Supplemental oxygen prior to sedation will provide extra time for the
health care provider to respond in the event that a patient experience apnea or signs of
impending respiratory arrest.
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
7. The practitioner (nurse) will provide and document a post procedural clinical
assessment based on the Aldrette Scoring System.
ASSESSED
FUNCTION
Activity
Respiration
Circulation
Consciousness
Color
ALDRETTE SCORING SYSTEM
DESCRIPTION
Voluntary movements of all limbs to command
Voluntary movements of 2 extremities to command
Unable to move
Breathe deeply and cough
Dyspnea, hypoventilation
Apneic
BP 20% of preanesthesia level
BP 20-50% of preanesthesia level
BP 50% of preanesthesia level
Fully awake or pre-procedure level
Arousable
Unresponsive
Pink
Pale, blotch, jaundice
Cyanotic
SCORE
2
1
0
2
1
0
2
1
0
2
1
0
2
1
0
ROOM SET-UP, EQUIPMENT, AND SUPPLIES REQUIREMENTS
The following is the required list of equipment and supplies that should be immediately
available in the procedural sedation room:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Ambu bags and airway supplies
Oxygen
Suction equipment with Yankauer tip
Monitoring equipment
Pulse oximetry
EKG
Blood pressure monitor
Crash cart unit
Reversal agents
POST ANESTHESIA CARE UNIT (RECOVERY) REQUIREMENTS:
1. Monitor, assess, and document the following:
A. Level of consciousness (including response to verbal interaction, commands)
B. Level of comfort
C. Level of knowledge, understanding
D. Nature of a procedure and any complications
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
2. Intervene appropriately based on results of continuous monitoring and assessment
(i.e. repositioning, administering of meds, education, comfort, physician
communication, etc.)
3. Explain procedure and educate patient as to expectations in the recovery and post
recovery phase.
4. Be vigilant to the signs, symptoms of complications of procedural sedation (that are
the same as general sedation)—including cardiac arrest, pulmonary arrest,
hypotension, aspiration, arrhythmia, allergic reaction, and shock.
5. Provide a comprehensive, meaningful report (SBAR—situation, background,
assessment, and recommendation—communication ) to the caregiver assigned to
follow the patient’s care.
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
DRUGS USAGE GUIDELINES:
Sedation Drugs and Reversal Agents
Romazicon
Narcan
Diluadid
Drugs
Morphine
Versed
Fentanyl
Ketamine
Etomidate
0
50
100
150
200
250
300
350
Minutes
Duration of Clinical Effect
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
1
**These guidelines are derived from published resources.
Doses in excess of these guidelines are at the discretion of the physician.**
ADULT SEDATION DRUG DOSAGE GUIDELINES
Approved Medications
Fentanyl (Sublimaze)
Hydromorphone (Dilaudid)
Midazolam (Versed)
Morphine Sulfate
Etomidate (Amidate) **ANESTHESIA AND ED ONLY**
Ketamine (Ketalar) **ANESTHESIA AND ED ONLY**
Naloxone HCL (Narcan)
Flumazenil (Romazicon)
2
A.
Drug Administration Guidelines
Fentanyl (Sublimaze)
Route:
IV, IM
Initial Dose:
Administer 0.5 – 1.0 micrograms/kilogram (Give
slow IV over 3-5 minutes; inject into infusing
line.)
Recommended Total Dose:
50-250 micrograms
Onset:
1-1.5 minutes
Peak:
5-15 minutes
Duration:
30-60 minutes
Half-life:
2-4 hours
Potential Adverse Reactions: Respiratory depression, apnea, rigidity, bradycardia,
hypotension, hypertension, dizziness, blurred vision, nausea, emesis, laryngospasm,
diaphoresis, hypersensitivity, sedation, drowsiness, convulsions, respiratory
depression,
peripheral circulatory collapse, cardiac arrest, allergic reactions, suppression of
cough reflex.
B.
Hydromorphone (Dilaudid)
Route:
IV
Initial Dose:
1-2 mg slow IV push
Recommended Total Dose:
4 mg (DO NOT EXCEED 0.1 mg/kg)
Onset:
15-30 minutes
Peak:
0.5–1 hour
Duration:
4-5 hours
Half-life:
2-3 hours
Potential Adverse Reactions:
Drowsiness, thrombosis, and phlebitis at the site of injections, slurred speech,
nausea, bradycardia, hypotension, respiratory depression, skin rash, blurred vision,
nystagmus, fluctuations in vital signs, apnea, hiccoughs, vomiting, coughing, over
sedation, and headache, increased CSF pressure.
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
C.
**These guidelines are derived from published resources.
Doses in excess of these guidelines are at the discretion of the physician.**
ADULT SEDATION DRUG DOSAGE GUIDELINES
Midazolam (Versed)
Route:
Initial Dose:
IV
0.5 mg – 2 mg slow IV over at least 2 min.; slowly
titrate every 2-3 minutes;
Recommended Total Dose: 2.5-5 mg (decrease dose in elderly)
IV:
Onset:
1 minute-5 minutes (IV)
Peak:
2-4 minutes (IV)
Duration:
1-4 hours; increased in cirrhosis, CHF, obesity,
elderly and acute renal failure)
IM:
Onset:
Within 15 minutes
Peak:
0.5-1 hour
Duration:
2 hours mean, up to 6 hours
Potential Adverse Reactions: Drowsiness, thrombosis, and phlebitis at the site of
injection, slurred speech, nausea, bradycardia, hypotension, respiratory depression,
skin rash, blurred vision, nystagmus, fluctuations in vital signs, apnea, hiccough,
nausea, vomiting, coughing, over sedation and headache. May potentiate the action
of other CNS depressants including opiate agonists or other analgesics, barbiturates,
other sedatives or anesthetics.
D.
Morphine Sulfate
Route:
Initial IV Dose:
IV
Administer 2-5 mg over at least 5 minutes into an
infusing IV line.
Recommended Total Dose: 15 mg (Do not exceed .15 mg/kg)
Onset:
1-7 minutes
Peak:
20 minutes
Duration:
4-5 hours
Half-life:
2-4 hours
Potential Adverse Reactions: Respiratory depression, hypotension, bradycardia,
CNS depression, nausea and vomiting, urinary retention.
E.
Etomidate (Amidate) – General Anesthetic
(**NOT RECOMMENDED FOR CHILDREN UNDER 10 YEARS**)
Route:
IV
Initial Dose:
0.2 – 0.6 mg/kg over 30-60 seconds
Recommended Total Dose:
Onset :
1 minute
Peak:
2-3 minutes
Duration:
3-5 minutes
Half-life:
75 minutes
Potential Adverse Reactions: nausea, vomiting, respiratory depression (15% of
patients), muscle twitching, adrenal suppression, hypotension
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
F.
**These guidelines are derived from published resources.
Doses in excess of these guidelines are at the discretion of the physician.**
ADULT SEDATION DRUG DOSAGE GUIDELINES
Ketamine (Ketalar) – Anesthetic Adjunct
Route:
IM / IV (**ADMINISTER OVER MINIMUM OF 60 SECONDS**)
Initial Dose:
ADULT
PEDIATRIC
IV :
1 - 4.5 mg/kg
0.2 – 1 mg/kg
IM:
0.5 - 4 mg/kg
2 – 10 mg/kg
Onset:
IV: 1 minute; IM: 5 minutes
Peak:
4-5 minutes
Half life:
10-15 minutes
Duration:
IV: 10-20 minutes
IM: 15-45 minutes
Potential Adverse Reactions: Contraindicated in patients with increased intracranial
pressure, Coronary Artery disease, increased blood pressure, convulsion, delirium,
hallucinations, amnesia, flashbacks possible for several weeks after use, agitation,
transient laryngospasm, ptyalism, respiratory depression, oxygen desaturation <
85% in < 1% of patients.
G.
Naloxone HCL (Narcan)
Route:
Initial Dose:
IV
Administer 0.1-2 mg every 2-3 minute intervals; Inject
into infusing line; may repeat every 20-60 minutes.
Onset:
Within 2 minutes
Half-life:
1-1.5 hours
Duration:
20-60 minutes
Recommended Total Dose: 10 mg
Potential Adverse Reactions: Excitement, hypotension, hypertension, ventricular
tachycardia and fibrillation, pulmonary edema, seizures, nausea, vomiting,
sweating, circulatory stress.
H.
Flumazenil (Romazicon)
Route:
Initial Dose:
IV
Administer 0.2 mg; administer over 15 seconds;
inject into infusing line; wait additional 45 seconds
before repeating, if necessary.
Recommended Total Dose: 1 mg.; administer additional dosages at 0.2 mg
(four additional times) at 1 minute intervals.
Onset:
1-3 minutes
Peak:
6-10 minutes
Half-life:
41-79 minutes
Potential Adverse Reactions: Nausea and vomiting, dizziness, injection site pain,
agitation, headache, sweating, flushing, hot flashes paresthesia, emotional liability,
inflammation at injection site, abnormal vision, fatigue, convulsions for patients on
benzodiazepines for seizure control.
**Duration: Resedation can occur usually within 1 hour; duration is usually
related to dose given.**
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
**These guidelines are derived from published resources.
Doses in excess of these guidelines are at the discretion of the physician.**
PEDIATRIC DRUG DOSAGE GUIDELINES
Drug Administration guidelines: For pediatrics > 2 years. (Neonates and Adolescents excluded)
MEDICATION
Sedatives ƒ
Midazolam
(Versed)
ROUTE
DOSE mg/kg
ONSET
DURATION*
COMMENTS
1-2 hours
•IV maximum
concentration—
1 mg/ml
•Decrease dose by 30% if
narcotics and other CNS
depressants are administered
concomitantly
•Rapid onset; amnesic;
Allow 3-5 min between
doses to decrease the chance
of oversedation.
•Maximum IM/IV dose—10
mg
20-30 min
1-2 hrs
0.3 mg/kg
20-30 min
1-2 hrs
0.2-0.3 mg/kg
5 min
30-60 min
•Concomitant use of
barbiturates, alcohol or
other CNS depressants may
increase the risk of
hypoventilation, airway
obstruction, desaturation, or
apnea and may contribute to
profound and/or prolonged
drug effect.
•Contraindicated in patients
with a known
hypersensitivity to the drug
or allergies to cherries or
formulation excipients.
•Rectal route: Dilute in 5
ml NS; administer rectally
•Nasal route: Use a 1 ml
needleless syringe into the
nare over 15 sec; use 5
mg/ml concentration; ½
dose may be given into each
nare
Deep IM
0.08 mg/kg0.1 mg/km
IM: 15 min.
IV
0.08-0.15 mg/kg
given over 10-20
min.
IV: 1-5 min.
PO
(Syrup)
0.4-0.5 mg/kg with
a maximum oral
dose of 15 mg
PR
IN (Nasal
Spray)
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Sonoma Valley Hospital – Medical Staff
Self-Study Guide for Procedural Sedation Credentialing
**These guidelines are derived from published resources.
Doses in excess of these guidelines are at the discretion of the physician.**
PEDIATRIC DRUG DOSAGE GUIDELINES
Drug Administration guidelines: For pediatrics > 2 years. (Neonates and Adolescents excluded)
MEDICATION
Ketamine
(Ketalar)
Analgesics
Fentanyl
(Sublimaze)
Morphine
Sulfate
ROUTE
IV
DOSE mg/kg
1-2 mg/kg
ONSET
1 min
DURATION*
10-20 min
COMMENTS
Requires IV be in place
before use in other then
emergent situations in the
Emergency Department.
Must have 1:1 nurse to
patient ratio.
IM
2-4 mg/kg
5 min
15-45 min
Requires IV be in place
before use in other then
emergent situations in the
Emergency Department.
Must have 1:1 nurse to
patient ratio
IV, IM
1-3 mcg/kg
May repeat at 3060 minute intervals
IV: immediate
IV: 30-60 min
IM: 7-15 min
IM: 1-2 hrs.
•Titrate in 1 mcg/kg doses
•Inject slowly 3-5 min
Rapid IV infusion may
result in skeletal muscle and
chest wall rigidity leading to
impaired ventilation and
apnea
0.05-0.2 mg/kg
5-15- min
IM: 3-5 hours
IV: 2-5 hours
IV, IM
•Administer IV for at least 5
min
•Watch out for hypotension,
bradycardia, peripheral
vasodilation, histamine
release
Hypnotics No reversal agent
available
=
IV
ƒ
0
LEGEND FOR PEDIATRIC MEDICATIONS:
Duration will vary according to dosages
Intramuscular
PR
IM
Intravenous
Intranasal
SL
IN
reversible with Romazicon
Per mouth/orally
PO
Rectally
Sublingual
reversible with Naloxone
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