Transcript Rules and Regulations of Enteral Sedation

ENTERAL CONSCIOUS
SEDATION
CHAPTER 110
Now All Sedation Rules and
Regulations Will Be in Chapter
108
THAT WE CAN DO AN
OFFICE ANESTHETIC DOES
NOT MEAN THAT WE MUST
Rule 110.1 Definitions…
Conscious Sedation
– A minimally depressed level of consciousness that
retains the pt’s ability to independently and
continuously maintain an airway and respond
apppro. to physical stimulation and verbal
command…
Rule 110.1 Definitions…
Conscious Sedation
– …drugs and/or techniques used should carry a margin of
safety wide enough to render unintended loss of
consciousness unlikely
– …response is reflex withdrawal from repeated painful
stimuli would not be considered to be in a state of
conscious sedation
New Definitions—ADA Guidelines
Conscious sedation term no longer exists
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Minimal
Moderate
Deep
General anesthesia
TSBDE Proposed New Rules
Five levels of anesthesia and sedation permits
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Nitrous Oxide/Oxygen Inhalation Sedation
Level 1—Minimal sedation
Level 2—Moderate Sedation (enteral only)
Level 3—Moderate Sedation (Parenteral
sedation)
– Level 4—Deep Sedation or General
Anesthesia
What do the Rule Changes Mean
Regarding Permitting?
Any dentist with an existing enteral permit
prior to date of implementation (6/1/2011)
will automatically have the permit
reclassified to a Level 1 Minimal Sedation
permit on 6/1/2011
Reclassified Level 1 permit holders may
continue to administer enteral sedation until
1/1/2013
What do the Rule Changes Mean
Regarding Permitting?
On or before 1/1/2013 dentist shall either
provide proof that adequate education has
been obtained by submitting an application
for a Level 2 permit on or before that date,
or shall comply with the requirements of a
Level 1 permit after that date.
Minimal Sedation
“A minimally depressed level of consciousness,
produced be a pharmacological method, that retains
the patient’s ability to independently and
continuously maintain an airway and respond
normally to tactile stimulation and verbal command.
Although cognitive function and coordination may be
modestly impaired, ventilatory and cardiovascular
functions are unaffected.”
Minimal Sedation
“In accord with this particular definition, the
drug(s) and/or techniques used should carry a
margin of safety wide enough never to render
unintended loss of consciousness. Further,
patients whose only response is reflex
withdrawal from repeated painful stimuli
would not be considered to be in a state of
minimal sedation”
Minimal Sedation
“When the intent is minimal sedation for
adults, the appropriate initial dosing of a
single enteral drug is no more than the
maximum recommended dose (MRD) of a drug
that can be prescribed for unmonitored home
use.”
Minimal Sedation
“The use of preoperative sedatives for
children (aged 12 and under) except in
extraordinary situations must be avoided due
to the risk of unobserved respiratory
obstruction during transport by untrained
individuals”
Minimal Sedation
“Children (aged 12 and under) can become
moderately sedated despite the intended
level of minimal sedation; should this occur,
the guidelines for moderate sedation apply”
Minimal Sedation
Supplemental dosing
– “During minimal sedation, supplemental dosing is a single
additional dose of the initial dose of the initial drug that
may be necessary for prolonged procedures. The
supplemental dose should not exceed one-half of the
initial dose and should not be administered until the
dentist has determined the clinical half-life of the initial
dosing has passed. The total aggregate dose must not
exceed 1.5x the MRD on the day of treatment”
Standard of Care Requirements…
….continuous direct supervision of auxiliary
personnel…
Maintain BLS for the assistant staff
No CRNA supervision for a level of sedation
that the dentist does not have current
permitting
Clinical Requirements…
Patient Evaluation
– ASA I, II
Review of their current medical history and medication
use
– ASA III, IV
May require medical consultation with PCP or specialist
Clinical Requirements…
Pre-Procedure Preparation and Informed Consent
– …..must provide written informed consent for the
proposed sedation
– Adequate oxygen supply
– Baseline vital signs must be obtained
– Focused physical evaluation must be performed as deemed
appropriate
– Pre-procedure dietary restriction….
– Pre-procedure verbal and written instructions must be
given to the patient, parent, escort, guardian, or caregiver
Clinical Requirements…
Monitoring
– DDS must remain in the operatory room to
monitor the patient until the patient meets
criteria for DC. Once the patient meets criteria
for DC the DDS may delegate monitoring to a
qualified dental auxiliary
Clinical Requirements…
Monitoring
– Oxygenation
Color of mucosa, skin or blood must be evaluated continually
Oxygen saturation via pulse oximetry should be used when a single
drug minimal sedation is performed….with the use of nitrous oxide
in combination pulse oximetry must be used
– Ventilation
DDS or qualified individual must observe chest excursions and
must verify respirations continually
– Circulation
BP an HR should be evaluated pre-, post- and intra-procedurally as
necessary
Clinical Requirements…
Documentation
– Names and dosages of all drugs administered and
individuals present during administration
– Time oriented sedation record may be considered
for documentation of all monitoring parameters
– SaO2, HR, RR and BP are the parameters which
may be documented at appropriate intervals of no
more than 10 minutes
Clinical Requirements…
Recovery and Discharge
– Oxygen and suction immediately available…
– DDS must monitor the patient during recovery
until the patient is ready for DC by the DDS.
May then delegate this task to an appropriately
qualified dental auxiliary
Clinical Requirements…
DDS must determine and document that the
patient’s level of consciousness, oxygenation,
ventilation and circulation are satisfactory
prior to discharge
DDS may not leave facility until the patient
meets the criteria for discharge and is
discharged from the facility
Clinical Requirements…
Post-procedure verbal and written instructions must
be given to the patient, parent, escort, guardian, or
care-giver. Post-procedure patients should be
accompanied by and adult caregiver for an
appropriate period of recovery.
Emergency management
Management of children
– AAP guidelines for monitoring and management of
pediatric patient
Moderate Sedation
“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”
Moderate Sedation
…drugs and techniques should carry a margin of
safety
…repeated dosing may result in a greater alteration
of consciousness
Withdrawal from only a painful stimulus not
considered moderate sedation
Titration
– Admin of incremental doses of a drug until a desired
effect is reached
Moderate Sedation
Knowledge of each drug’s time of onset, peak
response and duration of action is essential
to avoid over sedation. Although the concept
of titration of a drug to effect is critical for
patient safety, when the intent is moderate
sedation one must know whether the previous
dose has taken full effect before
administering an additional drug increment
Level 2 Permit..
Educational requirements
– BLS documentation
– ACLS or PALS or Board approved two-day
anesthesia emergency course
– Licensees with Level 2 Moderate Sedation
permits who provide anesthesia services to
children (<12) must document successful
completion of PALS course
Moderate Sedation…
Clinical Requirements
– ASA I, II vs. ASA III, IV unchanged
– …must provide written informed consent for the
proposed sedation
– Dietary restriction, baseline vitals, focused
physical examination—as per minimal
– Pre-procedure verbal or written instruction must
be given to the patient, parent, escort, guardian
or caregiver
Moderate Sedation…
Clinical requirements
– DDS and at least one other BLS certified
individual must be present
– Positive pressure oxygen
– Nitrous requirements
– Equipment necessary to establish intravenous
access must be available
Moderate Sedation…
Monitoring
– DDS must remain in the operatory to monitor
patient continuously until the patient meets the
criteria for recovery
– When treatment concludes and the patient
recovers to a minimally sedated level, DDS may
delegate a qualified dental auxiliary to remain
with the patient and continue to monitor until DC
Moderate Sedation…
Monitoring
– Consciousness
– Oxygenation
Skin color, mucosa or blood
Oxygen saturation must be evaluated by pulse oximetry
continuously
– Ventilation
Observation of chest excursions, auscultation of breath sounds,
end-tidal CO2, verbal communication with patient
– Circulation
BP and HR must be continually evaluated
Moderate Sedation…
Documentation
– Written time-oriented anesthetic record must be
maintained and must include names and dosages
of all drugs administered and names of individuals
present
– Pulse oximetry, HR, RR and BP must be continually
monitored and documented at appropriate
intervals of no more than ten (10) minutes
Moderate Sedation…
Recovery and Discharge
– Oxygen and suction immediately available
– While in recovery DDS/qualified staff must continually
monitor BP, HR, oxygenation and level of consciousness
– DDS must determine and document that the patient’s
level of consciousness, oxygenation, ventilation, and
circulation are satisfactory for discharge
DDS shall not leave facility until DC criteria is met
– Post procedural verbal and written instructions must be
given to the patient……
Moderate Sedation…
Recovery and Discharge
– If reversal agent is administered before
discharge criteria have been met, the patient
must be monitored until recovery is assured
Moderate Sedation…
Emergency Management
– The DDS is responsible for the sedation
management, adequacy of the facility and staff,
diagnosis and treatment of
emergencies….providing the equipment and
protocols for patient rescue.
– Immediate access to pharmacologic antagonists
and equipment for establishing a patent airway
and providing positive pressure ventilation with
oxygen
Moderate Sedation…
Emergency Management
– Advanced airway equipment and resuscitation
medications must be available
– Defibrillator should be available when ASA I and
II patients are sedated under moderate
sedation….and must be available when ASA III
and IV patients…
Continuing Education…
….must complete the following hours of CE biennial on the
administration of or medical emergencies associated with the
permitted level of sedation
– Level 1: Minimal Sedation – six (6) hours
– Level 2 and 3: Moderate Sedation – eight (8) hours
– Level 4: Deep Sedation/GA – twelve (12) hours
Anesthesia CE is in addition to courses required for licensure
– ACLS, PALS or Board approved two day emergency course may be
used to fulfill the CE requirement when not being taken for the
renewal of the permit