CLINICAL SUPPORT SERVICES

Conscious Sedation Policy

Contents

MGH Policy on Conscious Sedation for Non-Anesthesiologists 83

Introduction 83

Levels of Consciousness 84
Conscious Sedation (CS) 84
Deep Sedation 84
General Anesthesia 84

ASA Physical Status Classification of Patients 84

Classes I through V 84

Intravenous Conscious Sedation “At Risk” Patient Classification 85

Referral to the Department of Anesthesia and Critical Care 85

Additional Recovery Space 86

Escorts 86

Clarification of Patient Populations and Monitoring 86

Patient Population Clarifications 86
Cardiac Monitoring 86
Ventilation Monitoring 86

81
 DEPARTMENTAL OPERATIONS

Conscious Sedation Policy

Contents

Personnel and Training 87

Number of Personnel 87
Training 87
Pediatric Sedation 88
Credentialing and Privileging 88
Operator Privileges for the Administration of IV Conscious Sedation Form 89

Suggested Drugs and Dosages for Conscious Sedation 88

Consent 90

Monitoring 90

Documentation 90
Prior to Procedure 90
During Procedure 91
Following Procedure 91

Provisions for Patient Care Following the Procedure and Discharge Plan 91

Equipment and Maintenance 92

82

Section 1 Departmental Operations
Conscious Sedation Policy
MGH POLICY ON CONSCIOUS SEDATION
FOR
NON-ANESTHESIOLOGISTS
INTRODUCTION
The “1996 Policy on Conscious Sedation for
Non-Anesthesiologists” was officially adopted
as Hospital policy at the April 23, 1997 meeting
of the General Executive Committee.
This CS policy was formulated by a multi-
disciplinary committee under the auspices of
the Hospital’s Patient Care Assessment
Committee. The multi-disciplinary committee
was chaired by a member of the Department of
Anesthesia and Critical Care.
Each department using conscious sedation will
be responsible for the implementation of the
policy, assuring that participants in the admin-
istration and monitoring of CS patients are
appropriately credentialed, and the documen-
tation of such credentials shall be maintained
by the department.
The Department of Anesthesia and Critical Care
has, and will continue to assist in providing
expertise and information to other departments
or individuals in the following areas:
The appropriate drugs, dosages and
techniques for use during CS.
CLINICAL SUPPORT SERVICES
The development of guidelines for
the training, supervision and
credentialing of all individuals
involved in the care of patients under-
going CS.
Patient selection criteria, including the
identification of “at risk” patients
for whom the delivery of anesthesia
by non-anesthesia personnel is
inappropriate.
Patient monitoring requirements.
Arrangements to ensure the availabil-
ity of resuscitation support services at
all times.
Assisting departments in developing
mechanisms to continually measure
and evaluate the quality of anesthesia
services, including CS, wherever these
services are delivered. The ultimate
responsibility for implementing a
program to measure and evaluate the
quality of CS services, however, rests
with the individual department’s
quality assessment program.
83
 DEPARTMENTAL OPERATIONS
Although most of the conscious sedation is
administered by intravenous, conscious
sedation may follow the oral, sublingual,
nasal, rectal, percutaneous or intramuscular
routes. These guidelines apply to all routes of
administration of drugs whose goal is to
render the patient consciously sedated.
LEVELS OF CONSCIOUSNESS
CONSCIOUS SEDATION (CS)
Conscious sedation is a minimally depressed
level of consciousness that retains the patient’s
ability to maintain a patent airway indepen-
dently and continuously and respond
appropriately to physical stimulation and
verbal commands. CS may be administered
during therapeutic, diagnostic or surgical
procedures.
The drugs, dosages and techniques utilized for
CS are not intended to produce loss of
consciousness. This policy applies to CS
administered to patients undergoing diagnos-
tic, therapeutic or surgical procedures.
Conscious sedation should be distinguished
from two other levels of consciousness:
deep sedation and general anesthesia.
DEEP SEDATION
A controlled state of depressed consciousness
or unconsciousness from which the patient is
not easily aroused, accompanied by a partial
ASA PHYSICAL STATUS CLASSIFICATION OF PATIENTS
AMERICAN SOCIETY OF ANESTHESIOLOGISTS
(ASA)
PHYSICAL STATUS CATEGORIES
Class I
There is no organic, physiological, biochemical
or psychiatric disturbance. The pathologic
process for which operation is to be performed
is localized and is not a systemic disturbance.
Class II
Mild to moderate systemic disturbance caused
either by the condition to be treated surgically
or by other pathophysiological processes.
84
As stated in the definition below, there is a
continuum of conscious sedation, deep
sedation and general anesthesia that in an
individual patient may be difficult to control.
Therefore, any sedative drugs administered by
any route to obtain conscious sedation pre-
suppose the need for a trained, dedicated
person with proper equipment to monitor the
patient.
or complete loss of protective reflexes, includ-
ing loss of the ability to maintain a patent
airway independently and respond purpose-
fully to physical stimulation or verbal
command.
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 purpose-
fully to physical stimulation or verbal
command.
In actuality, a continuum exists among con-
scious sedation, deep sedation and general an-
esthesia. The patient’s age and preexisting
medical conditions may significantly alter the
dosing requirements needed for CS. If either
deep sedation or general anesthesia is required
for the procedure, skilled anesthesia personnel
should be available to manage the patient.
Class III
Severe systemic disturbance or disease from
whatever cause, even though it may not be
possible to define the degree of disability with
finality.
Class IV
Indicative of the patient with severe systemic
disorder already life-threatening, not always
correctable by the operative procedure.
Class V
The moribund patient who has little chance of
survival but is submitted to operation in
desperation.
 CLINICAL SUPPORT SERVICES

INTRAVENOUS CONSCIOUS SEDATION

“AT RISK”
PATIENT CLASSIFICATION
An anesthesia consult should be considered
under the following circumstances.
The patient has limited head/neck range of
motion.
The patient has abnormal cranio-facial anatomy.
The patient is morbidly obese.
The patient has sleep apnea.
Patient care units with significant expertise and
experience in providing conscious sedation to
ASA Class IV and V patients may petition the
Chief of Anesthesia and Critical Care, or his/
her designee, on an annual basis for an exemp-
tion to this requirement.
A patient who has required fiberoptic
intubation in the past.

This is not intended to be an all inclusive list, A patient with a history of difficult intuba-
but should serve as a guide for the identifica- tion in the past.
tion of patients for whom the delivery of IVCS
by non-anesthesia personnel may require an
anesthesia consultation.
An anesthesia consultation may be requested
An anesthesia consultation must be obtained by any medical care team at their discretion.
for the following indications: Following consultation the anesthesiologist will
solely determine if an anesthesiologist must
A patient is classified as ASA Class IV or V
administer conscious sedation.
(American Society of Anesthesiologists
Physical Status Classification).

REFERRAL TO THE DEPARTMENT

OF
ANESTHESIA AND
Certain patients are at increased risk of serious
complications from IVCS. To help select these
patients, the Department of Anesthesia and
Critical Care has formulated a set of guidelines
for those patients who are “at risk” for
complications from conscious sedation.
Patients requiring an anesthesia specialist
evaluation may be referred for a scheduled
pre-procedure consultation through the
Pre-Admission Test Area located on Jackson 1,
by calling the scheduling office, 6-3388. Patients
presenting for their procedures who require
immediate pre-procedural consultation will
receive one by paging the RICU consult (6-777,
#3408), although a thorough consultation may
necessitate delaying or rescheduling the
procedure.
CRITICAL CARE
Please note that although help in an emergency
(loss of patent airway, respiratory or circulatory
arrest) during procedures is always available
through the RICU consult or code call
mechanism, anesthesia consultants are
generally not available for intra-procedural
visits to aid in the pharmacological manage-
ment of problem patients. These patients
should be re-scheduled for their procedures
with anesthesia by calling the OR scheduling
office (6-2854).

85
 DEPARTMENTAL OPERATIONS
ADDITIONAL RECOVERY SPACE
Occasionally patients receiving conscious
sedation may lapse into deep sedation, have an
adverse reaction to medications or procedures,
and may require a prolonged period of
recovery before being discharged to their
inpatient units or to their home.
ESCORTS
The Board of Registration in Medicine Policy
on Conscious Sedation (Policy 94-004, p. 13)
mandates that “ambulatory care patients
should not leave the premises unless they are
CLARIFICATION OF PATIENT POPULATIONS AND MONITORING
PATIENT POPULATION CLARIFICATIONS
This policy includes all conscious sedation
patients except :
The administration of regional, general or
monitored anesthesia care outside of the
operating room by a member of the Department
of Anesthesia and Critical Care, which is
addressed by other policies and procedures
developed by the Department of Anesthesia
and Critical Care. Preoperative premedication
of patients prior to their transport to the
operating room is specifically excluded from
this policy.
The administration of intravenous sedatives
and analgesics according to approved therapeu-
tic protocols which are designed to serve as a
primary treatment for and/or as an adjunct in
the management of specified medical
conditions. Such medical conditions typically
consist of the use of Patient Controlled Analge-
sia pumps for the management of post
operative pain, the use of analgesics for the
purposes of dressing changes, burn care, chest
pain (angina), pulmonary edema and the use
of benzodiazapines for the management of
delirium tremens and seizures.
Oral anxiolytics (up to and including Diazepam
10 mg or equivalent) and IM or PO narcotics
86
Such inpatients may be transferred to the PACU
(call 6-2835 to request a bed) and outpatients
may be transferred to the PACU of the SDSU
(call 6-8593 to request a bed), both on a space-
available basis. Such transfers will trigger an
incident report to better enable individual
departments to monitor their delivery of
conscious sedation care.
under the care of a competent adult; . . .”.
JCAHO regulations are similar. The Depart-
ment of Anesthesia and Critical Care firmly
upholds this stipulation.
(up to and including morphine sulfate 15 mg
or equivalent drugs) given to the adult patient
for specified medical conditions are also
excluded.
Medications given to patients in intensive care
units (or other patients in a similar setting, such
as the cardiac catheterization laboratory) for
procedures such as invasive line placement or
pacemaker insertion.
CARDIAC MONITORING
The Department of Anesthesia and Critical Care
recommends that a cardiac monitor with
appropriate alarms be used on all patients with
an ASA classification equal to or greater than
III (severe systemic disturbance or disease from
whatever cause, even though it may not be
possible to define the degree of disability with
finality), or with a history of cardio-pulmonary
disease.
VENTILATION MONITORING
In addition to direct observation of respiratory
rate and pattern of breathing, the Department
of Anesthesia and Critical Care recommends
that capnography be utilized when available.

PERSONNEL AND TRAINING
The practitioner responsible for the treatment
of the patient and/or the administration of
drugs for intravenous conscious sedation shall
be appropriately trained.
NUMBER OF PERSONNEL
The minimum number of available personnel
shall be two - the operator (who performs the
surgical or diagnostic procedure) and the
monitor (an assistant trained to monitor
appropriate physiologic parameters and to
assist in any supportive or resuscitation
measures required), each assigned to their
specific roles in patient care for the purpose of
the planned procedure.
Such personnel will be on-site and available to
the patient from the time of administration of
the sedative medication until recovery is judged
adequate, or the care of the patient is transferred
to personnel performing recovery care. Both
the operator and the monitor shall be
appropriately trained in airway management,
monitoring and administration of intravenous
medications.
The monitor must be a licensed health care
professional (e.g., MD, DMD, PA or RN). The
monitor shall have no other significant
responsibilities; i.e., no tasks or duties which
would compromise his/her ability to monitor
the patient.
A third individual should be present to assist
with the procedure under certain circumstances
which have been identified as “High Risk;” e.g.,
the procedure to be carried out is particularly
complex or the patient’s medical condition may
require management beyond the capacity of the
practitioner(s). These “High Risk” procedures
shall be defined by each individual department
or service which have staff undertaking IVCS.
TRAINING
The director of the service providing the
monitor or operator personnel shall certify that
they are trained in airway management,
monitoring techniques and the safe use of
intravenous drugs.
CLINICAL SUPPORT SERVICES
“Trained in airway management” shall mean
that their training is consistent with the airway
management goals and procedures utilized for
advanced cardiac life support (or advanced
trauma life support), including positioning of
the airway, the use of oropharyngeal and
nasopharyngeal airways, and the application
of positive pressure ventilation by bag and
mask. Airway management skills and
knowledge of pharmacology will be recertified
annually.
“Trained in monitoring techniques and the safe
use of intravenous drugs” shall be achievable
through suitable educational programs,
including a course offered in conjunction with
designated members of the Department of
Anesthesia and Critical Care.
The Department of Anesthesia and Critical
Care will participate in the organization of a
hospital-wide educational program to inform
practitioners of guidelines for the use of sedat-
ing agents and monitoring modalities. It would
be appropriate for such a program to be
accredited for continuing education in risk
management.
The means for notifying additional support
services such as Respiratory Therapy and
“code” pages should be clearly identified and
posted in procedure/sedation areas.
It is the physician with clinical privileges to
perform procedures using CS who selects and
orders the sedation in accord with the CS policy.
Physicians asking for CS privileges as well as
licensed health care professionals who are
responsible for monitoring the patient should
have similar documentation of course
completion in ACLS, ATLS and/or competency
achieved through individual tutorials or other
courses in airway management, monitoring and
the pharmacology of the medications given.
87
 DEPARTMENTAL OPERATIONS
PEDIATRIC SEDATION
Guidelines for A Teaching Program and
Credentialing of Personnel Involved in
Pediatric Sedation for Patients Under the
Age of Thirteen (13) Years.
INSTRUCTION PROGRAM
One yearly lecture — for 30-60 minutes with
discussion to follow.
Recognition and Treatment of problems
of airway management, ventilation,
oxygenation and sedative drugs follow-
ing AAP guidelines.
Pharmacology of sedative drugs and
their effects on children.
Current PALS certification or comparable MGH
developed training.
Each department will be responsible for
arranging lecture sessions with the Pediatric
Anesthesia Team. Additional hands-on airway
and ventilation management of actual pediat-
ric patients during anesthesia under the
scrutiny and evaluation of a staff pediatric
anesthesiologist may be arranged on an
individual basis.
CREDENTIALING AND PRIVILEGING
The Commonwealth of Massachusetts Board of
Registration in Medicine stipulates (Policy 94-
004, pp 4-5) that “anesthesiologists should
assist in providing expertise and information
SUGGESTED DRUGS
FOR
CONSCIOUS SEDATION
The appended list is intended only as a guide
to choice of drug and dosage for conscious
sedation. Certain patients may not tolerate
even these recommended doses especially
when sedatives and narcotics are used in
combination.
A reduction of dose should be considered and
extreme care taken when administering IV
sedation to infants, the elderly and any patient
with an acute severe illness.
88
to other departments or individuals in . . . the
development of guidelines for the training,
supervision, and credentialing of all individu-
als involved in the care of patients undergoing
intravenous conscious sedation. . .”.
In order to fulfill this obligation and provide
consistency in credentialing, the Massachusetts
General Hospital Department of Anesthesia
and Critical Care requests that any department
in which physicians or DMDs will be
credentialed in conscious sedation, submit to
the Chief of Anesthesia and Critical Care (or
his/her designee) a curriculum designed to
fulfill the requirements of the policy.
Members of the Department of Anesthesia and
Critical Care are available to aid department
chiefs develop such a curriculum. This effort
will be coordinated by Dr. Mary Kraft,
ext. 6-1880.
In addition, a privileging form has been devel-
oped for use by such departments where
conscious sedation is performed. It is intended
that individual physicians requesting privileges
in conscious sedation complete a form
bi-annually and submit it to the Chief of
Anesthesia and Critical Care (or his/her
designee) for approval.
Department chiefs are also encouraged to
generate a list of procedures within their
departments wherein conscious sedation is
customarily employed to enable them to better
monitor the quality of care delivered by
members of their departments.
AND DOSAGES
In general, the best approach is to start with
about 25% of the estimated induction dose, give
plenty of time to observe peak effect and titrate
to desired level of sedation and pain relief with
subsequent small doses at appropriate intervals.
After the initial sedative effect has waned
repeat doses may be administered cautiously
at about 25% of the induction dose to maintain
sedation and pain relief at the desired level.
 CLINICAL SUPPORT SERVICES

MASSACHUSETTS
GENERAL HOSPITAL
Operator Privileges
for the
Administration of IV Conscious Sedation

Name: ____________________________________ Department/Service:________________________

(Please print)

Physicians and other professional practitioners granted privileges to perform IV

conscious sedation will adhere to the standards for personnel and training,
location and equipment, and patient management and monitoring as set forth in
the 1996 MGH Policy on Conscious Sedation for Non-Anesthesiologists.

In requesting IV conscious sedation privileges, I verify the following:

1. Familiarity with and willingness to abide by the MGH IV conscious sedation

policy and procedure.

2. Privileges in performing the associated procedure(s) for which IVCS will be

administered.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

3. Familiarity with the use and interpretation of data from:

~ Pulse Oximeter ~ Cardiac Monitor

4. Have training and/or experience in:

~ ACLS/equivalent ~ ATLS/equivalent ~ Approved MGH training program

5. Familiarity with the pharmacology of drugs used in conscious sedation including:

Expected patient response.
Effects on vital signs.
Signs and treatment of overdose.
Assessment of residual drug effect.
6. Familiarity with the use of flumazinil and naloxone for the reversal of the effects of
conscious sedation.

I agree to abide by the above criteria.

________________________________________ ___________________
Signature Date

Approved by:

________________________________________ ___________________
Medical Director of IV Conscious Sedation Date

89
 DEPARTMENTAL OPERATIONS
CONSENT
The patient/guardian must be informed about the risks of and
alternatives to sedation as a component of the planned procedure.
Documentation of consent should be placed on the procedural record
prior to the procedure.
MONITORING
Whenever drugs for conscious sedation are
administered, a licensed health care profes-
sional shall monitor the patient. A conscious
sedation patient shall be frequently and
periodically observed by the monitor.
The patient must be continually monitored by
direct observation and by indirect physiologic
measurement such as pulse oximetry. The
monitor may also perform other tasks which
do not detract from his/her ability to observe
the patient.
If the administration of drugs for conscious
sedation inadvertently results in deep sedation,
the monitor shall stay with the patient,
sedation administration shall be discontinued,
and attention will be paid to giving the patient
additional ventilatory or circulatory support
as needed.
DOCUMENTATION
There shall be written documentation on all
aspects of care rendered to the patient.
PRIOR TO PROCEDURE
Baseline health evaluation shall include a
brief health history reflecting:
Allergies and previous adverse drug reactions.
Current medications.
Diseases, disorders and abnormalities.
Prior hospitalizations.
Pertinent family history of diseases or disorders.
Review of systems.
A physical examination reflecting:
Height and weight.
Vital signs.
Baseline oxygen saturation.
Airway assessment.
Chest and cardiac examination.
90
Heart and respiratory rates and
patient responsiveness must be
assessed at least every five minutes.
A stethoscope for monitoring heart
rate, respiratory rate, and adequacy of
tidal volume is considered to be mini-
mum monitoring equipment needed.
Blood pressure should be measured
and recorded prior to the initiation of
intravenous sedation and measured at
least every five minutes thereafter.
Head position should be checked
frequently to ensure a patent airway.
Oxygen saturation shall be monitored
non-invasively on a continuous basis
by pulse oximeter.
A risk assessment including the American
Society of Anesthesiologists (ASA) Physical
Status Category:
Patients who are classified as ASA I, II, or III
may have CS given by non-anesthesiologists.
Patients classified as ASA IV or V (or any
patient for whom there is a question of medical
stability outside of intensive care units) will be
referred to members of the Department of
Anesthesia and Critical Care for scheduling for
further evaluation, monitoring and sedation.
Patient care units with significant expertise and
experience in providing conscious sedation to
ASA IV and V patients may petition the Chief
of Anesthesia and Critical Care or his/her
designee on an annual basis for an exemption
to this requirement. In an emergent case, non-
anesthesiologists may administer conscious
sedation.

Dietary precautions (NPO history), consistent
with policies for adult and pediatric patients
established for elective procedures elsewhere
within the institution.
Rationale for sedation.
The sedation plan.
Patient’s physician and telephone number.
DURING PROCEDURE
The licensed practitioner shall record:
Vital signs, including heart rate, respiratory
rate, blood pressure and patient responsiveness
as soon as possible after each 5 minute
assessment interval. In addition, blood
pressure shall be recorded prior to initiation of
sedation and after each dose of medication.
Oxygenation: oxygen saturation by pulse
oximetry as soon as possible after each 5 minute
assessment interval.
PROVISIONS FOR PATIENT CARE
FOLLOWING THE PROCEDURE AND DISCHARGE PLAN
When the procedure has been completed and
the patient is being readied for discharge or
transfer, the vital signs and patient respon-
siveness shall be monitored by licensed
practitioners in a properly equipped area with:
Functioning suction apparatus.
Capability of delivery more than 90% oxygen
with positive pressure ventilation (bag and
mask).
Means of obtaining and recording vital signs
at specific intervals.
Pulse oximetry monitoring shall be available for
patients who are not fully alert until the patient
meets discharge criteria, having returned to his
pre-procedure state.
CLINICAL SUPPORT SERVICES
Medications given (route, site, time, drug and
dose), including oxygen therapy in liters/
minute and means delivered (e.g., nasal prongs,
re-breathing mask, etc.).
FOLLOWING PROCEDURE
The time of discharge and patient condition.
Discharge plan (name of responsible party,
patient location).
Patient instructions, to include an explanation
of potential or anticipated post-sedation effects
and limitation on activities and behavior includ-
ing dietary precautions. A 24 hour emergency
contact telephone number should be provided
to all patients.
Release to a less well monitored level of care
should only be permitted when:
Airway, breathing and circulation are adequate
and stable.
The patient is alert, if appropriate to baseline.
The patient can sit unaided, if appropriate to
baseline and procedure.
The patient can walk with assistance, if appro-
priate to baseline and procedure.
The state of hydration is adequate.
If patients are to be discharged home, they must
be under the care of a competent adult.
If patients are to be transferred to further care
within the institution, standard criteria shall be
applied for transfer of care.
91
 DEPARTMENTAL OPERATIONS

EQUIPMENT AND MAINTENANCE

A self-inflating positive-pressure oxygen
delivery system capable of delivering 90%
oxygen at a 15 liter/minute flow rate for at least
60 minutes must be available.
Various bag and mask sizes must be available
in those circumstances where appropriate, e.g.
pediatric patients.
A source of suction (portable or wall) must be
available, with a vacuum capability of 18-24
inches of mercury, or flow capability of 100 L/
min with an orifice size of 14 mm.
Equipment that will provide a maxi-
mum of 100% and never less than
21% oxygen concentration.
Equipment outfitted with an oxygen
analyzer to monitor the accuracy of
delivered gases.
Equipment that is checked and
calibrated annually, or according to
a maintenance schedule established
in conjunction with the hospital’s
Biomedical Engineering Department.

A pulse oximeter for non-invasive monitoring
of oxygen saturation must be used.
A device for taking blood pressure (manual or
automatic) should be present, with a variety of
cuff sizes to accommodate arms of varying
circumference.
There will be a cardiac monitor with alarm,
capable of displaying wave forms.
A care plan that excludes or limits the
prior administration of other
sedative or narcotic medications.
All equipment shall be inventoried and main-
tained on a regularly scheduled basis, in
conjunction with policies established
by the Hospital’s Biomedical Engineering
Department.

An emergency cart must be readily available,

and should include the necessary equipment
and drugs to treat any emergency ranging from
an apneic or unconscious patient to a full
cardiac arrest. Standardized hospital
resuscitation carts can generally be utilized for
this purpose.

Equipment appropriate to the technique being

used should be available in good working
order immediately before, during and after the
procedure. This shall include means for provid-
ing supplemental oxygen delivered via nasal
prongs and non-re-breathing or re-breathing
oxygen masks.

When inhalation conscious sedation is

provided with nitrous oxide, it must be
delivered with:

Equipment that cannot provide a

concentration of nitrous oxide in
excess of 50% inspired. Equipment
that will deliver greater than 50%
nitrous may be employed in special-
ized units; i.e., oral surgery certified
for the administration of general
anesthesia.

92