ST. VINCENT MEDICAL CENTER
Administrative Policy & Procedure
SUBJECT:
Page:
1 of 9
Originating
Dept:
Quality Services
Originating
Date:
9/99
Reviewed:
Revised
Date:
3/07
APPROVED BY:
Sedation (Moderate), Procedural
□ Management Council
□ Anesthesia Section
□ Surgery Committee
REFERENCE:
AORN Recommended Practice for Local Anesthesia with IV; Conscious Sedation, 2003; Physician Desk
Reference, 2003 JCAHO 2005
PROCEDURAL SEDATION STATEMENT:
Procedural Sedation is a minimally depressed level of consciousness during which the patient retains the ability to
maintain a patent airway and respond appropriately to physical or verbal commands. This type of sedation is
accomplished by the use of appropriate analgesics and sedatives.
PURPOSE:
1.
To outline the responsibilities and requirements in the administration of medication used for moderate
(procedural) sedation during invasive or non-invasive procedures.
2.
To assure that patients receive a comparable level of care when receiving moderate (procedural) sedation
throughout the hospital.
POLICY:
1. Accountability
The Department of Anesthesia, with input from the hospital Medical Staff, Administration, Pharmacy and
the Department of Nursing is responsible and accountable for assuring the safe implementation of this
policy and procedure.
2.
Definitions
The standards for sedation and anesthesia care apply when patients receive in any setting, for any purpose,
by any rout, moderate or deep sedation as well as general, spinal or other major regional anesthesia.
Definitions of four levels of sedation and anesthesia include the following:
a. 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.
b. Moderate sedation/analgesia (“Conscious 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.
c. Deep sedation/analgesia
This is 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.
d. Anesthesia
Consists of general anesthesia and spinal or major regional anesthesia. It does not include local
anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are
not arousable, even by painful stimulation. The ability to independently maintain ventilatory
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
2 of 9
Originating
Dept:
Quality Services
Originating
Date:
9/99
Revised
Date:
3/07
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.
Minimal Sedation
(Anxiolysis)
Moderate Sedation/
Analgesia
(Conscious Sedation)
Purposeful response to
verbal or tactile
stimulation
Responsiveness
Normal response to
verbal stimulation
Airway
Unaffected
Spontaneous
Ventilation
Cardiovascular
Function
Unaffected
No intervention
required
Adequate
Unaffected
Usually maintained
Deep Sedation/
Analgesia
General Anesthesia
Purposeful
response following
repeated or painful
stimulation
Intervention may
be required
May be adequate
Unarousable even
with painful stimulus
Usually maintained
Intervention often
required
Frequently
inadequate
May be impaired
3.
Patient selection and evaluation is the responsibility of the physician.
4.
This policy does not apply to the administration opioids and other agents to provide peri-operative or postoperative analgesia.
5.
Administration is approved in the following locations:







Emergency Department
G.I. Lab
Operating Room
Post Anesthesia Care Unit
Cardiac Cath. Lab.
Special Procedures – Radiology
Critical Care Units
4.
An informed consent must be obtained prior to the administration of medication.
5.
Medication used is prescribed by the physician and is based upon the patient’s age, weight, medical condition,
pain tolerance, past history, and the procedure being performed. Route of administration of sedation:
a.
Oral Agents: The administration of oral anxiolytics prior to a procedure is a common method of providing
sedation. In common dosing ranges, the uptake and associated level of sedation is gradual and predictable.
Because of these factors, and the associated margin of safety, oral sedation usually requires no special
monitoring during or after the procedure. Any patient assessed by the attending physician or nursing staff to
have special needs or a profound sedative effect after receiving an oral agent (decreased response to verbal or
physical stimulation, profound somnolence, decreased respiratory rate) should be monitored as patients who
receive IV sedation. For pediatric patients (0-17 years old), they will be monitored as receiving IV sedation.
b.
Intramuscular (IM) Agents: The same standards applied to patients receiving oral agents for sedation apply
to patients receiving IM sedation in common dosing ranges.
c.
Intravenous Agents: All patients receiving IV sedation will be fully monitored as outlined in the Policy and
Procedure.
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
3 of 9
Originating
Dept:
Quality Services
Originating
Date:
9/99
Revised
Date:
3/07
6.
Patients receiving procedural sedation require continuous cardiac monitoring and pulse goniometry, except MRI
patients due to magnetic field interference. Monitoring is recommended with equipment compatible with the
MRI.
7.
Emergency equipment including O2, defibrillator, suction and crash cart must be available where the procedure
is occurring prior to the start of the Procedural Sedation.
8.
Continuous uninterrupted monitoring and assessment of the patients clinically and physiologic parameters shall
be conducted by a licensed RN with current BLS including airway management and procedural sedation
competency.
9.
In the event of Procedural Sedation must be administered outside of the approved locations, the Anesthesiology
Section Chief or the covering anesthesiologist must be notified to approve a safe temporary setting for the
procedure. Approval will be documented in the patient’s medical record.
10. Pain assessment will be monitored per pain protocol.
PROCEDURE:
EQUIPMENT:
-
Crash Cart
Pulse Dosimeter
Airways
Suction Equipment
Ambu Bag
Device for obtaining temperature
ECG Monitor
Sedation Medication and Reversal Agents
Defibrillator
Blood Pressure Monitoring Device
IV Solution
Oxygen (Mask or cannula)
* Pediatric Equipment/ sizes are necessary in Pediatric cases
CARE OF THE PATIENT
PRE-PROCEDURE:
Physician Responsibility (Physician must be granted privilege to perform procedural sedation)
1. Completes appropriate pre-op documentation including:
-
history and physical
medical statement of patient’s condition indicating that the patient is appropriate for the type of
anesthesia.
Schedules patient for procedure needed.
Utilizes only approved procedural sedation locations.
2. Pre-procedure assessment- includes focused assessment, current medications and allergies (including
anesthesia reactions).
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
4 of 9
Originating
Dept:
Quality Services
Originating
Date:
9/99
Revised
Date:
3/07
3. Pre-anesthesia score (ASA) – Will be completed and documented on the form using one of the following
categories:
1. Class 1- Normal healthy patient; focused assessment should include an evaluation of patients
airway.
2. Class 2 – Patient with mild system disease (e.g. slightly limiting organic heart disease, mild
diabetes, essential hypertension, anemia, chronic bronchitis).
3. Class 3 – Patient with severe systemic disease (e.g., insulin-dependent diabetes,
immunosuppressed, moderate degree of pulmonary insufficiency, stable CAS, asthma, extreme
obesity). For class 3 and above, monitored anesthesia care (MAC) is recommended. Requires
careful evaluation by the physician to determine if the magnitude of the procedure will require the
involvement of an anesthesiologist for patient safety.
4. Class 4 – Patient with severe systemic disease that is constant threat to life (e.g., organic heart
disease with marked signs of cardiac insufficiency, persistent angina, active myocarditis, advanced
degree of pulmonary hepatic, renal or endocrine insufficiency). Anesthesia should be notified.
5. Class 5 – Moribund patient not expected to survive 24 hours. Anesthesia should be notified
6. Emergency – An emergency procedure without the ability to determine appropriate class will
automatically be reviewed.
4. Documented Plan of Sedation- (identification of selected agent) will be completed.
5.
Informed consent – Will be completed which will include the risks, benefits and alternatives.
NURSE RESPONSIBILITY
RATIONALE
1.
Obtain doctor’s order for procedural sedation.
2.
Verify signed informed consent.
3.
Assures that the patient has been NPO
minimum of 6 hours (except in emergencies)
and a pertinent H&P is on the chart. Children
may have clear liquids up to 3 hours
before procedure.
to avoid possible aspiration.
4.
Assess any airway obstruction and ease of .
Intubation by examining airway and teeth.
To avoid potential risk.
5.
Assures emergency equipment as listed is
available and operational.
6.
Assess patient for any drug allergies
prior to administration of sedation.
To avoid any potential drug allergy reaction.
7.
Connects patient to monitoring devices.
Documents level of consciousness, baseline
blood pressure, pulse, respiratory rate, heart
rhythm, oxygen saturation, and temp.
*Temperature should be monitored on
patients <1 year of age before, during and
after procedure
Assess and assign patient with Aldrete score.
Establishes a baseline.
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
5 of 9
Originating
Dept:
Quality Services
Originating
Date:
9/99
Revised
Date:
3/07
DURING PROCEDURE:
NURSE RESPONSIBILITY
1. Just prior to the start f the procedure a final
“Time Out” will occur. At this time, there
Will be a verbal confirmation of correct
Procedure and site by the procedural team and
Verification in the patient’s record.
RATIONALE
To assure patient safety
2. The nurse and/or physician in attendance
administers intravenous drugs for sedation
under the direction of the physician.
Titrating dosages allow time to assess for
drug reaction and intervention if necessary.
3. V/S are checked before and after each dose
and recorded on the appropriate monitoring
record.
4. All of the above vital signs are monitored at least
every 15 minutes or more frequently as indicated
especially after medication given and before
additional medication is used. They are recorded
on the appropriate monitoring record.
5. The patient is continuously checked for changes in
condition and/or untoward responses or effects.
These are reported to the responsible physician
immediately.
Patient should be arousable and able to
respond to commands
POST PROCEDURE:
PHYSICIAN RESPONSIBILITY
1. Documents a post-anesthesia note and includes a statement regarding absences of complications or
problems with anesthesia.
2. Writes post-procedure orders.
NURSE RESPONSIBILITY
1.
Continue to assess and document vital signs and physical parameters every 15 minutes and as needed until the
patient’s Aldrete score equals to 10 or pre-procedure score.
2.
Document how the patient tolerated the procedure.
3.
Document all findings and interventions on the appropriate monitoring record and clinical record.
4.
Oxygen may be removed when saturation levels are maintained above 90% or baseline.
5.
Notify the responsible physician if the patient does not meet the discharge criteria within 30 minutes.
DISCHARGE CRITERIA FROM
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
6 of 9
Originating
Dept:
Quality Services
Originating
Date:
9/99
Revised
Date:
3/07
1.
At completion of the procedure, the patient should be monitored until a post-procedure score of 10 is reached or
the pre-procedure score is reached. The patient may then be returned to the floor or discharged.
2.
If the patient does not meet the above criteria, a physician’s order is necessary for discharge.
DISCHARGE CRITERIA FROM FACILITY
All post procedure patients must meet the following criteria prior to discharge.
1. Patient has returned to pre-procedure LOC.
2. Vital sign are stable:
3.
BP within 20 mmHg of pre-procedure value;
systolic BP must be greater than 90
Pulse 60-100 or within 10% of pre-procedure value
Respiration within 20% of pre-procedure value
No evidence of active bleeding from surgical site.
4. Pain level assessed<4 or within two levels of pre-assessed pain scale.
5. Verbal and written discharge instructions given.
6. A responsible adult to accompany patient.
PATIENT / FAMILY EDUCATION
RATIONALE
Prior to Procedure:
Give explanations based on developmental
age and ability to accept information.
To allay fear, anxiety and obtain patient’s
cooperation.
Prior to Discharge:
1. If appropriate, give the patient or
responsible adult other instructions on the care
of the anesthetized body part, including:
Prevents accidental post procedure injury
which could result from decreased
sensation in the body part that has been
anesthetized by local anesthesia.
- avoidance of excessive heat or cold
- awareness of decreased motor control
- time frame to expect return of sensitivity
2. Report to physician any excessive pain,
bleeding, edema, redness, and prolonged
return of function.
Early recognition of signs and symptoms
of complications to enable intervention.
3. Give the patient instructions to avoid the
use of alcohol or other non-prescribed
drugs.
To prevent complications from drug
interactions. Complete elimination of
the IV drugs may take 24 hours.
4. Avoid activities requiring mental alertness
for 24 hours. A responsible adult shall
Driving and other activities that require an
alert mental state must not be attempted
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
7 of 9
Originating
Dept:
Quality Services
accompany patient when discharged.
Originating
Date:
9/99
Revised
Date:
3/07
for the safety of the patient.
ALDRETE SCORING CRITERIA
Respiration:
2 – Spontaneous respiration, (needs no support) normal rate.
1 – Spontaneous respiration, needs artificial airway.
0 – Intubated, needs ventilator.
Circulation:
2 – Stable BP/ Pulse. BP = 20 mm Hg of pre-anesthesia level (minimum 90 mm H
1 – BP = 20-50 mm Hg of pre-anesthesia level.
0 – Abnormally low or high BP = 50 mm Hg pre-anesthesia level.
Color:
2 – Normal skin color.
1 – Pale. Blotchy.
0 – Cyanotic. Dusky.
Consciousness:
2 – Awake, alert, oriented to time, place, person.
1 – Drowsy/ sleepy and response to verbal stimuli.
0 – Unresponsive or responds only to pain stimuli.
Activity (exception: patients who were immobile pre-op):
2 – Moves all extremities, can lift head.
1 – Moves all extremities, cannot lift head.
0 – Unable to move extremities or lift head
MEDICATIONS ADMINISTERED FOR PROCEDURAL SEDATION:
The following medications may be administered by a physician, or by a registered nurse under direct supervision of
a physician. The following routes of administration and doses are recommended but can be modified as clinically
indicated (based on the patient’s age and physical condition) at the determination of the supervising physician.
PEDIATRIC PATIENTS
ORAL AGENTS
(<5 years of age)
Diazepam
Midazolam
Chloral Hydrate
INTRAMUSCULAR AGENTS
Midazolam
Morphine Sulfate
Meperidine
Ketamine (ER Only)
RECTAL AGENT
Chloral Hydrate
INTRAVENOUS AGENTS
Ketamine (ER, ICU physicians
only)
DOSE
< 0.25 mg/kg
0.3 – 0.5 mg/kg
25 – 100 mg/kg up to 1 grm
0.05 – 0.1 mg/kg
0.05 – 0.1 mg/kg
0.75 – 1.5 mg/kg
3 – 7 mg/kg
50 mg/kg
0.2mg – 2 mg/kg
Pediatric patients receiving IV sedation will
be attended by a practitioner credentialed in
the procedure.
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
8 of 9
Originating
Dept:
Quality Services
ADULT PATIENTS
ORAL AGENTS
INTRAMUSCULAR AGENTS
INTRAVENOUS AGENTS
Originating
Date:
9/99
Revised
Date:
3/07
INITIAL DOSE
Diazepam
Lorazepam
Midazolam
Morphine Sulfate
Meperidine
Ketamine (ER Only)
2 - 10 mg
1 – 2 mg
1 – 5 mg
2 – 6 mg
25 – 100 mg
1 - 4 mg/kg
Diazepam
Lorazepam
Midazolam
Fentanyl
Morphine Sulfate
Meperidine
Hydromorphone
Etomidate (ER, ICU physicians
Only)**
1 – 2 mg
0.5 – 1 mg
0.5 – 1 mg
25 – 50 mcg
1 – 4 mg
12.5 – 50 mg
0.5 mg – 1 mg
0.2 mg/kg for intubation
0.1 mg/kg for sedation
Ketamine (ER, ICU physician
Only)**
0.2 mg – 2 mg/kg
Propofol (ER, ICU Physicians
Only)**
1 – 2.5 mg/kg for intubation
10 – 20 mg for sedation
or infusion 25 – 50 mcg/kg/min
Subsequent doses may be given after reassessment by physician.
** Propofol, Ketamine and Etomidate are limited to use by Emergency Room Physicians and ICU physicians for
intubation. Propofol used for conscious sedation may only be given in the presence of a physician
REVERSAL AGENTS FOR PROCEDURAL SEDATION
REVERSAL AGENTS
ROMAZICON
(Flumazenil)
Range: 0.1mg – 3 mg
Must be given IV only
NEVER GIVE AS A BOLUS, need to titrate the drug IV over 15
seconds and in increments of 0.2 mg and wait at least 1 minute
between additional doses up to a maximum of 1 mg/5 minutes.
EACH DOSE TAKES 6-12 MINUTES TO REACH FULL
EFFECT. Therefore, the dose must be individualized for each
patient.
Resedation may occur. Repeat doses may be given up to a
maximum of 1 mg every 20 minutes. Do not exceed 3 mg in one
hour.
CAUTION: May induce seizures. Give smallest dose possible to
obtain desired effect.
ST. VINCENT MEDICAL CENTER
Page:
Administrative Policy & Procedure
SUBJECT:
Sedation, Procedural
9 of 9
NARCAN
(Naloxone HCL)
Range: 0.2 mg- 2 mg
May be given IV, IM, or Sub
Q.
May repeat doses every 2-3
minutes up to total of 10 mg.
Originating
Dept:
Quality Services
Originating
Date:
9/99
Revised
Date:
3/07
NEVER GIVE AS A BOLUS, need titrate the drug IV over 15
seconds and in increments of 0.2mg every 2-3 minutes until
desired effect is reached.
The duration of action of narcotic may exceed the reversal effect
of Narcan. Therefore, patients must be monitored closely for
return of narcotic depression and repeat doses of Narcan a may be
needed in 1 – 2 hours.
Give only the amount of Narcan necessary to restore spontaneous
ventilation and alertness without causing pain and discomfort as a
result of reversing the narcotic
CAUTION: Abrupt reversal of narcotic depression may result in
nausea, vomiting, sweating, tachycardia, increased B/P, seizures
and cardiac arrest.