1. An Update on Procedural Sedation
A Primer on the Rules!
Shiva Birdi M.D.
Staff Anesthesiologist and Intensivist
Anesthesiology Institute
Cleveland Clinic
May 14, 2009

2. primum non nocere
First, Do No Harm

3. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

4. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

5. The Old “Conscious Sedation”
• Inconsistent pre-
procedure screening
• NO requirement for
documentation
• NO major monitoring
standards
• NO quality or
performance
evaluation
requirement
• NO credentialing
required

6. Goals of Procedural Sedation
• Patient Comfort
o Reduce Pain
o Reduce Anxiety
• Patient Safety
o Maintain cardiopulmonary function
o Minimize and manage related complications
• Improve Efficiency
o Optimize procedural conditions
• Adequate Recovery
o Patient returned to pre-procedural functional
and physiologic level

7. A Bit of History
• Midazolam (Versed®) introduced in
United States in mid 1980s
•86 Deaths in first 5 years of use
• Majority related to procedural
sedation
Epstein B. Department of Health and Human Services, Office of Epidemiology and
Biostatistics,
Center for Drug Evaluation and Research. Data Retrieval Unit HFD-737; June 27, 1989.

8. Dangers of Sedation
• Bailey et al.
o Healthy Volunteers
o Given midazolam, fentanyl or both
o Hypoxemia (92%) and Apnea (50%)
 combination of midazolam and fentanyl
• Reported to Department of Health
and Human Services
Bailey et al. Anesthesiology. 73(5):826-830, Nov 1990

9. Dangers of Sedation
• Iber et al. 1
o 10 pts developed Apnea or Cardiopulmonary
Arrest during or following endoscopy
• Arrowsmith et al. 2
o ASGE/FDA Collaborative Study
o >21K GI endoscopy procedures
o “Serious” CV complications 5.4 / 1000
• Vargo et al. 3
o 49 pts upper endoscopy
o 57% with 54 episodes of apnea (>30 sec)
o 50% with hypoxemia
1IberFL et al. J Clinical Gastroenterology 1992; 14:109–13
2Arrowsmith et al. Gastrointestinal Endoscopy, 1991; 37:421–7
3Vargo et al. Gastrointestinal Endoscopy 55:826-831, 2002

10. 98,000 Preventable Deaths
$17 billion to $29 billion cost

11. • MAC claims
o > 40% with death or
brain damage
• Most common injury
o Respiratory depression
from
over-sedation
• Median Payment
o $240,000

12. 44% judged to be PREVENTABLE
By
Better Monitoring
(pulse oximetry, capnography, improved
vigilance, or audible alarms)

13. Mainstream Media

14. Dangers of Sedation
• Airway Disaster / Aspiration
• Respiratory Depression
• Cardiovascular Complications
• Paradoxical Response to sedation
• Medication Related Events
• Inadequate Sedation / Movement
• Nausea and Vomiting
• Patient Dissatisfaction

15. Possible Solutions ?
• Provider Education and
Training
• Patient Selection
• Improved Monitoring
• Increased VIGILANCE

16. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

17. Continuum of Depth of Sedation
(Developed by the American Society of Anesthesiologists)
(Approved by ASA House of Delegates on October 13, 1999,
and amended on October 27, 2004)
Minimal Moderate Sedation Deep Sedation / General Anesthesia
Sedation / Analgesia Analgesia
(“Anxiolysis”) (“Conscious
Sedation”)
Responsiveness Normal Purposeful* Purposeful* Unarousable, even
response to response to verbal response following with painful
verbal or tactile repeated or painful stimulus
stimulation stimulation stimulation
Airway Unaffected No intervention Intervention may Intervention often
required be required required
Spontaneous Unaffected Adequate May be inadequate Frequently
Ventilation inadequate
Cardiovascular Unaffected Usually maintained Usually maintained May be impaired
Function
* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response

18. Continuum of Depth of Sedation
(Developed by the American Society of Anesthesiologists)
(Approved by ASA House of Delegates on October 13, 1999,
and amended on October 27, 2004)
Moderate Sedation / Analgesia Deep Sedation /
(“Conscious Sedation”) Analgesia
Responsiveness Purposeful* response to verbal Purposeful* response
or tactile stimulation following repeated or
painful stimulation
Airway No intervention required Intervention may be
required
Spontaneous Adequate May be inadequate
Ventilation
Cardiovascular Usually maintained Usually maintained
Function
* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response

19. Moderate Sedation/Analgesia
• The Old “Conscious Sedation”
• Patient RESPONDS PURPOSEFULLY to
verbal commands/light stimulation
• NO airway manipulation required
• Spontaneous ventilation maintained
• Cardiovascular function usually
maintained

20. Deep Sedation/Analgesia
• Patient not easily aroused
• Patient RESPONDS PURPOSEFULLY to
repeated or painful stimulation
• Airway manipulation MAY BE required
• Spontaneous ventilation MAY BE
inadequate
• Cardiovascular function usually
maintained

21. Brief List of Procedures
• Endoscopic Examinations (GI)
• Vascular and Cardiac Catheterizations
• Cardioversion and EPS procedures
• Burn/Wound Debridement
• Foreign Body Removal
• Complex Laceration Repair
• Fracture Reduction / Orthopedic
• Diagnostic Procedures (ex. MRI/CT)
• Tube Thoracostomy
• Central Line Placements (including
tunneled)

22. Some Exclusions
• Preoperative medications
• Patient controlled analgesia
• Post-operative or labor analgesia
• Pain Management (dressings, burns or
angina)
• Sedation in the intensive care unit
• Sedation for treatment of insomnia
• Anxiolysis (single dose)
• Drug or alcohol withdrawal or prophylaxis
• Treatment of seizure disorders
• Multiple trauma patients in the ER

23. Practice Guidelines for Sedation and
Analgesia by Non-Anesthesiologists
• Approved by ASA, October 17, 2001
• 10 task force members (Dr. Zuccaro – CCF)
• 51 consultants from 17 specialties surveyed
• Based on review of 1876 articles over 44
year period
o (357 with direct-linkage related evidence)
EVIDENCE BASED GUIDELINES

24. As the details
became more and
more transparent …

25. The Joint Commission was
watching…

26. …and after thorough survey,
inspection and review…

27. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

28. STANDARDS UPDATED
• Adopted ASA Evidence Based Guidelines
and Depth of Sedation Continuum
• Joint Commission on Accreditation of
Healthcare Organizations: "Standards and
Intents for Sedation and Anesthesia Care,"
in Revisions to Anesthesia Care Standards,
Comprehensive Accreditation Manual for
Hospitals. Oakbrook Terrace, Ill., Joint
Commission on Accreditation of Healthcare
Organizations, 2001. (updated 2004)

29. “Comparable Care” Mandate
“There must be no decrement in
the care delivered to patients
during their entire continuum of
care within the hospital.”

30. Bottom Line
• All “conscious sedation” areas (OR
and non-OR) must have processes
(pre-sedation assessment, intra-
procedure monitoring, discharge
criteria), facilities, equipment,
and personnel similar to those
utilized for MAC delivered by qualified
anesthesia providers in the OR.

31. JCAHO Standards
• Assessment of Patients (PE)
• Care of Patients (TX)
• Improving Organizational
Performance (PI)

32. JCAHO Standards
• Assessment of Patients (PE)
o PE.1.8.1
 Any patient for whom moderate or deep sedation or
anesthesia is contemplated receives a pre-sedation or pre-
anesthesia assessment
o PE.1.8.2
 Before anesthesia, the patient is determined to be an
appropriate candidate for anesthesia.
o PE.1.7.3
 The patient is re-evaluated immediately before anesthesia
induction
o PE.1.8.4
 The patient's postoperative status is assessed on admission
to and discharge from the post-anesthesia recovery area
Cohen et al. ASA Newsletter. May 2001

33. JCAHO Standards
• Care of Patients (TX)
o TX.2.0
 Moderate or deep sedation and anesthesia are provided by
qualified individuals
o TX.2.1
 A pre-sedation or pre-anesthesia assessment is performed
for each patient before beginning moderate or deep sedation
and before anesthesia induction.
o TX.2.1.1
 Each patient's moderate or deep sedation and anesthesia
care is planned.
o TX.2.2
 Sedation and anesthesia options and risks are discussed with
the patient and family prior to administration
Cohen et al. ASA Newsletter. May 2001

34. JCAHO Standards
• Care of Patients (TX) – contd.
o TX.2.
 Each patient's physiological status is monitored during
sedation or anesthesia administration
o TX.2.4
 The patient's post-procedure status is assessed on admission
to and before discharge from the post-sedation or post-
anesthesia recovery area
o TX.2.4.1
 Patients are discharged from the post-sedation or post-
anesthesia recovery area and the organization by a qualified
LIP or according to criteria approved by the medical staff.
o TX.3.5.5
 Emergency medications are consistently available, controlled
and secure in the pharmacy and patient care areas
Cohen et al. ASA Newsletter. May 2001

35. JCAHO Standards
• Improving Organizational Performance (PI)
o PI.4.
 Data are systematically aggregated and analyzed on an
ongoing basis
o PI.4.2.
 The organization compares its performance over time
and with other sources of information
o PI.4.3.
 Undesirable patterns or trends in performance and
sentinel events are intensively analyzed .
o PI.4.4.
 The organization identifies changes that will lead to
improved performance and reduce sentinel events
Cohen et al. ASA Newsletter. May 2001

36. What this means
for the Provider?

37. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

38. Patient Selection
• Planned Procedure
o Associated physiologic derangements
• Patient’s Medical Status
o CoMorbid Conditions
o Preoperative Status is Optimized
o Airway Exam
o NPO Guidelines
• Intended Level of Sedation/Analgesia
o Must be decided in advance
o Moderate vs. Deep

39. Pre-Procedure Assessment
• Focused H&P
o Summary of Patient Current Condition
o Review Medications and Allergies
o Review of Co-Morbid Diseases
o Previous adverse rxn to sedation/anesthesia
o Last PO Intake (time and nature)
o Cardiac, Pulmonary and Airway exam
• MUST be reviewed immediately prior to
procedure for any changes

40. ASA Classification
E: after the Class would represent an emergency

41. ASA Classification
ASA Closed Claims Study (for sedation)1
• age greater than 70 years
• ASA physical status III to V
THESE RESULTED IN HIGHER LITIGATION
1Bhananker, S et al. Anesthesiology. 2006:Feb;104(2):228-234.

42. Mallampati Score

43. Mallampati Score
OTHER RELAVANT HISTORY:
H/O Snoring
Thick Neck
Difficulty with Neck ROM
MAY BE HIGH
RISK FOR AIRWAY
DIFFICULTIES

44. High Risk Patients
• Extremes of Age • Pregnancy
• Severe cardiac, • H/o drug abuse or
pulmonary, renal, EtOH abuse
or hepatic disease • H/o difficulty with
(ASA class ≥ III) sedation or
• Potential difficult anesthesia
intubation • DEEP Sedation is
(MP score ≥ III) planned

45. High Risk Patients
• Extremes of Age • Pregnancy
• Severe cardiac, • H/o drug abuse or
pulmonary, renal, EtOH abuse
or hepatic disease • H/o difficulty with
(ASA class ≥ III) sedation or
• Potential difficult anesthesia
intubation • DEEP Sedation is
(MP score ≥ III) planned
IF ONE or MORE of these risk factors
And DEEP sedation planned
CONSIDER GETTING ANESTHESIOLOGY INVOLVED

46. Informed Consent
• MUST INCLUDE:
o Consent for the Procedure
o Consent for the Planned Sedation /
Analgesia
o R / B / A / P for BOTH must be done

47. Staffing Requirements
• Two Licensed Professionals Required
o Proceduralist
 Licensed Independent Practitioner
o Qualified Assistant (Monitoring Physician
or RN)
 “Supervised Sedation Professional”1
• Appropriately Credentialed
o Different for Moderate and Deep
Sedation
1ASA Guidelines. October 2006

48. Ohio Board of Nursing
( July 2007)
• RN (not CRNA) cannot engage in
administration of medications that
induce DEEP SEDATION or GENERAL
ANESTHESIA
• RN cannot engage in activities that
divert attention away from the
patient
www.nursing.ohio.gov

49. Registered Nurse Credentials
INSTITUTIONAL CREDENTIALING REQUIREMENTS +
• Supervised by LIP (Moderate Sedation Only)
• Pharmacology
o Age- and weight- related dosage, reversals
• Monitoring
o Pulse oximetry, Cardiac monitors
• Level of consciousness assessment
• Pain assessment
• Arrhythmia recognition
• Basic Airway management
• ***Recognition of Deep Sedation***

50. Sedation Practice
(JCAHO and ASA Guideline)
• Understand Sedation Continuum
• Difficult to predict individual patient
response to sedation
• MUST be able to “RESCUE” patient
from next level of sedation
MODERATE • DEEP
DEEP • GA

51. RESCUE and RETURN
(JCAHO and ASA Guideline)
• Sedation Practitioner must be able to
RESCUE a patient one level above the
intended level of sedation
• After RESCUE the patient is
RETURNED to the original intended
level of sedation

52. Physician Credentialing
• “Each organization is free to define how it will
determine that the individuals are able to perform
the rescue” (JCAHO Feb, 2009)
• “Physicians administering or supervising moderate
or deep sedation/analgesia should have
appropriate education and training” (ACS ST-46
April 2004)
• “Only physicians…with adequate training,
education and licensure to administer moderate
sedation should supervise…” (ASA Statement
October 2006)

53. Physician Credentialing
• ER, ICU excluded
• Competency and Training in:
o Oxygen delivery systems
o Basic cardiovascular physiology
o Pharmacology of sedatives and reversal
agents
o Understanding and knowledge of
required and emergency equipment
o KNOW HOW TO CALL FOR HELP !

54. Moderate Sedation
• Sedation/Analgesia Training and Privileging
o Institution dependent
(ex. Online or Live Sedation Course followed by a quiz)
o ***Recognition of Deep Sedation***
• Basic Resuscitative Techniques
o BCLS (renew every years)
• Demonstrate proficiency in airway
management with bag-mask ventilation

55. Deep Sedation

56. Deep Sedation
Requirements for Moderate Sedation +
• Advanced Resuscitative Techniques
o ACLS, ATLS (renew every 2 years)
• Demonstrate ability to manage associated
complications including slipping into General
Anesthesia
• Advanced airway management skills including use
of airway assist devices and manage compromised
airways
(ex. Airway workshop offered at institution)

57. Equipment
• Oxygen Supply
• Pulse Oximetry
• Blood Pressure
• *EKG* (as indicated for at risk patient in
moderate but a MUST for deep)
• *Capnography* (beneficial adjunct for
monitoring adequacy of ventilation)
o Does not replace examination of patient
• Emergency equipment
o Suction
o Crash Cart
o Airway Rescue Equipment

58. Special Note
• Supplemental oxygen decreases
incidence of hypoxemia
• Adequate OXYGENATION does not
mean adequate VENTILATION
• REVERSAL agents (Naloxone,
Flumazenil) must be available
• IV access must be maintained
throughout the procedure and
recovery phase

59. Procedural Sedation Record
Performed by a Dedicated Qualified Assistant
• Document Vitals at regular intervals
o Moderate sedation (q 10 min)
o Deep sedation (q 5 min)
• Pain and Sedation Scoring System
o Oxygen Saturation and Respiratory Rate
o Level of consciousness (ex. Ramsey Scale)
o Verbal and visual exam by monitoring assistant
• Airway Manipulation Interventions
o Chin lift, Jaw thrust, adjunct airway, MV, etc.
o May assist in post procedure audit

60. Recovery
• Standards of Monitoring continue
• Appropriate staff available
• Documentation continues
• In-patients
o must return to baseline function and
physiological status prior to return to RNF
• Out-patients
o alert and oriented
o stable vital signs
o baseline ambulation status
o pain and nausea well controlled

61. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

62. Quality Improvement
• Hospital Quality Improvement
o Certification of Procedure Sedation Site
o Oversight of sedation practice and evaluation of
patient outcomes
o Monitor and Identify System Failures to Reduce
Incidence of Sentinal Events*
*A sentinel event is an unexpected occurrence
involving death or serious physical or
psychological injury, or the risk thereof .
*Joint Commission Standards

63. Quality Improvement
• Department Quality Improvement
o Applies to each department providing
Moderate Sedation
o Systematically gather and analyze data
on a continuous basis
o Establish Department Specific Quality
Markers and Thresholds
o Develop Quality Reports that are
reviewed by Hospital QI
o Perform regular reviews

64. Examples of Quality Markers
• ANY need to Rescue patients from
unintended deeper level of sedation
• ANY usage of airway manipulation
maneuvers
• ANY major change in VS (Sat/BP)
• ANY major cardiopulmonary event
• ANY use of reversal agents
• ANY prolonged recovery phase

65. Objectives
• Background
• “Continuum of Sedation”
• New JCAHO Standards
• Patient Selection & Credentialing
• Process and Quality Improvement
• Final Thoughts

66. Final Thoughts …
• PATIENT SELECTION IS CRITICAL
• Anesthesia involvement for patients
at high risk for sedation complications
• Titration of sedative / analgesics
• Adequate oxygenation DOES NOT
equal adequate ventilation
• EARLY RECOGNITION OF DEEPER
THAN INTENDED SEDATION

67. Key Resources
• Continuum of Depth of Sedation
• ASA Sedation Guidelines for Non-
Anesthesiologists

68. Pass the Survey!
• CREDENTIALING MUST BE
MAINTAINED!
• EVERY PATIENTS PROCEDURAL
SEDATION PLAN SHOULD BE
INDIVIDUALIZED
o Avoid “COOKBOOK” Techniques

69. Pass the Survey
• Quality and Process Improvement
Strategies employed across the
Institution
• Compliance with JCAHO “Comparable
Care Mandate”
PRIMARY GOAL: PATIENT SAFETY

70. Conclusion
Procedural Sedation is extremely
Safe and Effective
when performed on well selected,
adequately informed patients, by
appropriately trained, credentialed, and
well supported providers.

71. ADEQUATE PREPARATION LEADS TO A
SAFE, EFFECTIVE AND SATISFACTORY
EXPERIENCE

72. QUESTIONS ?
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