Lesson 1: Introduction Lesson 2: The Sedation Continuum Lesson 3: Guidelines & Regulations Erlinda C. Oracion, M.D., D.P.B.A Department of Anesthesiology.

Lesson 1: IntroductionLesson 2: The Sedation Continuum

Lesson 3: Guidelines & Regulations

Erlinda C. Oracion, M.D., D.P.B.ADepartment of Anesthesiology

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Sedation and anesthesia are important risk factors for morbidity and mortality during procedures.

Giving sedation safely is critical to:

Help prevent negative outcomes Comply with regulations

This course will teach you:

How moderate sedation relates to other types of anesthetic services, and how this relates to patient safety

How The Joint Commission expects accredited facilities to manage moderate sedation

After completing this course, you should be able to:

List the levels of the continuum of sedation

Identify key features of each level Recognize the significance of the continuum for sedation safety

List the Joint Commission standards for moderate sedation

Identify key requirements of each standard

Administration of sedatives and analgesics for performance of procedures is a significant independent risk factor for morbidity and mortality both inside and outside the OR.

Although sedation is often offered as “safer than general anesthesia”, this may not be altogether correct.

1984- Natof studied 40 ambulatory centers (87,492 patients)

Complications 1: 106 (LA with sedation) vs 1:120 (GA)

NAPS (Nurse Administered Propofol Sedation) 2000 patients- GI endoscopies (ASA 1 and 2)

3- laryngospam 11 desaturated <90% spO2 despite 4L/min O2 4 desaturated <85% spO2, were assumed apneic

Lesson 1 provided the course rationale and goals

Lesson 2 will describe the sedation continuum

Lesson 3 will list and explain the Joint Commission standards for moderate sedation

After completing this lesson, you should be able to:

List the levels of the sedation continuum

Identify key features of each level

Recognize the significance of the sedation continuum

Moderate sedation is on a continuum with other levels of sedation.

The levels on this continuum are: Minimal sedation (anxiolysis ) Moderate sedation/analgesia (formerly “conscious sedation”)

Deep sedation/analgesia General Anesthesia

Minimal sedation is also called anxiolysis.

In this drug-induced state: The patient feels relaxed . The patient responds normally to speech.

Thinking and coordination may be affected.

Breathing and heart function are not affected

In this drug-induced state:

The patient has depression of consciousness

The patient will respond purposefully to spoken words, or spoken words with a light touch.

The airway remains patent without help.

The patient’s breathing is adequate. Heart function is usually maintained.

Deep Sedation/Analgesia is the next level on the continuum.

In this drug-induced state: The patient has depression of consciousness and is difficult to awaken.

The patient will respond purposefully to repeated or painful stimulation. Reflex movement away from pain is not “purposeful”.

The patient may need help to keep the airway open.

The patient’s own breathing may not be adequate.

Heart function is usually maintained.

General Anesthesia is the deepest form of sedation.

In this drug-induced state: The patient loses consciousness. The patient cannot be awakened, even by painful stimuli.

The patient often needs assistance maintaining the airway and ventilation. This often requires positive pressure ventilation.

Heart function may be impaired.

MINIMAL SEDATION-anxiolysis

MODERATESEDATION-conscious sedation

DEEPSEDATIONGENERALGENERAL

ANESTHESIAANESTHESIAGENERALGENERAL

ANESTHESIAANESTHESIA

This table summarizes the sedation continuum.

Minimal

Sedation

(anxiolysis)

Moderate

Sedation/

Analgesia

Deep Sedation/

Analgesia

General

Anesthesia

Responsiveness Normal response to speech

Purposeful response to speech or touch

Purposeful response to repeated or painful stimulation

No response, even to pain

Airway Unaffected Remains open May need help to maintain airway

Often needs help to maintain airway

Breathing Unaffected Adequate May not be adequate

Often require ventilatory support

Heart Function Unaffected Usually maintained

Usually maintained

May be impaired

Continuum of Depth of Sedation

• 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.

• (conscious sedation): a drug-induced depression of consciousness during which the 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.

• 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.

• A drug-induced loss of consciousness- patients not arousable, even by painful stimulation.

• Ability to maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of a depressed spontaneous ventilation or drug-induced depression of neuromuscular function.

• Cardiovascular function may be impaired.

MINIMAL SEDATION-anxiolysis

MODERATESEDATION-conscious sedation

DEEPSEDATIONGENERALGENERAL

ANESTHESIAANESTHESIAGENERALGENERAL

ANESTHESIAANESTHESIA

MAC does not describe the continuum of depth of sedation;

“a specific anesthesia service in which an anesthesia provider has been requested to participate in the care of the patient undergoing a diagnostic/ therapeutic procedure.”

• Sedation is a continuum- not always possible to predict how an individual patient will respond.

• Skill required ability to rescue from deep sedation levels

This table summarizes the sedation continuum.

Minimal

Sedation

(anxiolysis)

Moderate

Sedation/

Analgesia

Deep Sedation/

Analgesia

General

Anesthesia

Responsiveness Normal response to speech

Purposeful response to speech or touch

Purposeful response to repeated or painful stimulation

No response, even to pain

Airway Unaffected Remains open May need help to maintain airway

Often needs help to maintain airway

Breathing Unaffected Adequate May not be adequate

Often require ventilatory support

Heart Function Unaffected Usually maintained

Usually maintained

May be impaired

Continuum of Depth of Sedation

Why is it important to understand the continuum of sedation?

Because sedation is a continuum, the response of any one patient may be unpredictable.

Why is it important to understand the continuum of sedation?

A moderately sedated patient may progress to deep sedation.

Therefore, moderate sedation must be monitored just as carefully as deep sedation and anesthesia.

The best description of “moderate sedation” is:

a. A risk-free treatment b. A point on the continuum of

sedationc. A lesser form of sedation than

“minimal sedation”d. A treatment entirely different

from general anesthesia

You have completed the lesson on the sedation continuum.

Remember: Moderate sedation is a point on a continuum. It falls between minimal sedation and deep sedation.

Because sedation is a continuum, the response of any patient is individual and may be unpredictable.

Minimal sedation

(anxiolysis)

Moderate sedation/ analgesia

(conscious sedation)

Deep sedation/

analgesia

General Anesthesia

Administering clinicians

RN, Physicians Sedation trained RN, Credentialed physicians

Anesthesiologist only

Anesthesiologist only

Responsiveness Normal response to verbal stimulation

Purposeful** response to verbal or tactile stimulation

Purposeful** response following repeated or painful stimulation

Unarousable even with painful stimulus

Airway Unaffected No intervention required

Intervention may be required

Intervention often required

Spontaneous ventilation

Unaffected Adequate May be inadequate Frequently inadequate

Cardiovascular function

Unaffected Usually maintained

Usually maintained May be impaired

1. Blunting of anxiety and fear2. Elicit cooperation from the

patient3. Afford amnesia for the patient4. Increase the pain threshold

should be able to -rescue a patient who enters a state of deep sedation -manage a compromised airway -provide adequate oxygenation and ventilation

Introduction & Objectives

Welcome to the lesson on guidelines and regulations.

After completing this lesson, you should be able to:

List the The Joint Commission standards related to moderate sedation

Identify key requirements of each standard

"conscious sedation" for non-operating room procedures represents a dynamic continuum significantly overlapping monitored anesthesia care (MAC), this implies that such areas must have processes presedation assessment, intraprocedure monitoring, discharge criteria, facilities, equipment, and personnel similar to those utilized for MAC delivered by qualified anesthesia providers.

mandates that sedation practices throughout the hospital be "monitored and evaluated by the Department of Anesthesiology"

Question: Does the person administering sedation have to be qualified to monitor the patient if other staff who are present are qualified?

Standard PC. 13.20 states, “Sufficient numbers of qualified staff (in addition to the individual performing the procedure) are present…” to evaluate, monitor, administer medication, assist with the procedure if needed and recover the patient.

The Joint Commission has several standards for anesthesia services, including moderate sedation.

For Moderate sedation, these standards are:

Moderate sedation must be given by a qualified provider.

Patients who will receive moderate sedation must be assessed ahead of time.

Sedation options and risks must be discussed with the patient and family prior to the sedation/procedure.

For Moderate sedation, these standards are:

The patient must be re-assessed immediately before the sedation is given.

The patient’s oxygenation, ventilation and circulation must be monitored during sedation.

The patient must be assessed in the post-sedation recovery area before discharge.

A qualified provider must discharge the patient from the post-sedation recovery area, or discharge must be based on established criteria .

All patients must be assessed before sedation.

Hospitals with obstetric or emergency services should be able to perform an assessment quickly.

These hospitals should be able to gather enough information to give moderate sedation safely within 30 minutes after deciding to sedate the patient.

The patient must give informed consent before moderate sedation can be administered.

The pre-sedation assessment should include information about the procedure and the patient.

The Assessment should include: Indication for the procedure Determination that the patient is an appropriate candidate for sedation and the procedure

The Pre-sedation assessment should also include:

Patient history—should include: Allergies or adverse drug events Prior sedative or anesthesia experiences

Potential for pregnancy

Pre-sedation assessment should also include:

Physical History—should include: Baseline vital signs and oxygen saturation

Weight Airway status Appropriate fasting interval Aspiration risk factors Status of cardiac, pulmonary, and neurologic systems

Mental status and level of consciousness

Appropriate lab tests ASA status

The patient’s ASA status should be determined.

The ASA describe five physical status classes: ASA Class I – A normal healthy patient. ASA Class II – A patient with mild systemic disease.

ASA Class III – A patient with severe systemic disease.

ASA Class IV - A patient with severe systemic disease that is a constant threat to life.

ASA Class V – A moribund patient who is not expected to survive without the operation.

ASA Class VI – A declared brain-dead patient whose organs are being removed for donor purposes.

Patients in ASA classes I and II can be given moderate sedation.

Medical consultation is suggested for class III patients.

Patients in ASA classes IV and V should not be given moderate sedation by a non anesthesia provider.

Conditions that will affect the use of moderate sedation:

• Indication for the procedure• Altered mental status• Atypical airway anatomy• Obesity• Pregnancy• Sleep apnea • Current medications

• Substance abuse• Cardiovascular disease• Respiratory disease• Liver disease• Kidney disease • Central nervous system dysfunction

Sedation options and risks may be discussed with the patient and family before giving moderate sedation.

Patients must give informed consent for any treatment. This includes moderate sedation.

Part of informed consent is a full understanding of the options and risks of treatment.

Discussing the sedation procedure ahead of time can also help calm patient fears.

Patient education also should include information on:

Resuming activity Consciousness checks Dietary restrictions When medications can be resumed Potential post-procedural complications

Whom to contact for questions for help

The moderate sedation of each patient must be carefully planned.

The Plan of Care should: Take into account the physical status of the patient (ASA class)

Meet any other patient needs identified during the pre-sedation assessment

All providers should be informed of: The patient’s care needs The sedation plan of care

The patient should be assessed again immediately before moderate sedationis given.

Question: Are specific privileges to administer moderate sedation required?

Standard PC. 12.20 EP 4 states that “Individuals monitoring moderate or deep sedation are qualified and have the appropriate credentials to manage patients whatever level of sedation or anesthesia is achieved…”

The qualified provider requirement covers the training and credentials of the provider who gives moderate sedation.

A provider “qualified” to give moderate sedation must be trained in: How to evaluate patients before sedation How to give drugs for moderate sedation How to monitor patients to keep them moderately sedated

How to “rescue” patients from deep sedation

The ability to “rescue” patients from deep sedation includes training in:

How to manage an airway How to give oxygen and ventilation How to deliver appropriate reversal agents

“Rescue” of patients from sedation may also include the use of “reversal drugs.”

Patients given reversal drugs must be monitored. Seizures or other heart and nervous system problems may occur.

Note: The effect of the reversal drug may wear off before the effect of the sedating drug. Extended monitoring will be needed.

Moderate sedation procedures are performed by a licensed independent practitioner (LIP)

The qualified provider requirement also covers the number of personnel during a procedure.

In addition to the LIP, there must be enough other qualified personnel to:

Evaluate the patient before the sedation

Give the sedation Perform the procedure Monitor the patient Recover and discharge the patient

Patients must be monitored during moderate sedation.

The person monitoring the patient can not have additional assignments.

Physiological monitoring is the only way to ensure that patients get the supportive treatment they need.

Mandatory equipmentMandatory equipment•Cardiac monitorCardiac monitor•Pulse oximeterPulse oximeter•Medications for sedation and reversal of effectMedications for sedation and reversal of effect•Blood pressure determination unitBlood pressure determination unit•Oxygen source and administration equipmentOxygen source and administration equipment•Bag-valve-maskBag-valve-mask•Standard emergency equipment and drugs for resuscitationStandard emergency equipment and drugs for resuscitation•DefibrillatorDefibrillator•Suction machineSuction machine•StethoscopeStethoscope

The following need to be monitored in some or all patients:

Heart rate and oxygenation—should be continuously monitored by pulse oximetry.

Respiratory rate--& pulmonary ventilation should be continuously monitored

Blood pressure—should be measured at regular intervals.

EKG—should be monitored: If the patient has significant cardiovascular disease

If cardiac arrhythmias are expected or detected.

Data from monitoring must be recorded in the patient’s medical record.

After moderate sedation, patients must be: Assessed in the post-sedation recovery area Discharged by a qualified LIP or according to established criteria

Discharged home with a responsible adult

Meeting discharge criteria should be documentedin the medical record.

MULTIPLE CHOICE INTERACTION

A provider qualified to give moderate sedation is trained in:

a. How to evaluate patients before sedationb. How to rescue patients from deep

sedationc. How to give drugs to achieve moderate

sedationd. How to monitor patients to keep them

moderately sedated e. All the above

MULTIPLE CHOICE INTERACTION

The physical status of a patient with well-controlled hypertension would be:

a. ASA class Ib. ASA class IIc. ASA class IIId. ASA class IVe. ASA class V

Remember:

Patients must be assessed before moderate sedation. ASA class should be determined

Sedation options and risks must be discussed with each patient.

A sedation care plan must be developed for each patient.

Remember:

Moderate sedation must be given by a qualified provider.

Patients must be monitored during sedation.

Patients must be assessed after sedation.

Note: They may be discharged from the post-sedation recovery area only by a qualified LIP or according to established criteria.

Course Glossary# Term Definition

1. Analgesia Pain relief

2. Anxiolysis The use of drugs to lessen anxiety without lessening awareness

3. Apnea Not breathing

4. ASA American Association of Anesthesiologists

5. Continuum On a scale progressing from the smallest to the greatest amount

6. Criteria Standards or measures used to make a judgment or decision

7. The Joint Commission

Joint Commission of the Accreditation of Healthcare Organizations

8. Positive pressure ventilation

Artificial breathing using positive pressure to maintain inflation of the lungs

9. Reversal drugs Drugs that neutralize the effects of the drugs used to sedate the patient

10. Sedation Sleepiness, or the act of cause sleepiness

List the levels of the continuum of sedation

Identify key features of each level Recognize the significance of the continuum for sedation safety

List the Joint Commission standards for moderate sedation

Identify key requirements of each standard