1. Procedural Sedation
S. Greg Escue, MD
8/28/2008

2. Outline Introduction Definition Preparation Summary of key points
Patient Assessment
Personnel
Equipment
Monitoring
Medications
Summary of key points

3. ACEP Clinical Policy Level A recommendations Level B recommendations
Generally accepted principles for patient management that reflect a high degree of clinical certainty (ie, based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all the issues)
Level B recommendations
Recommendations for patient management that may identify a particular strategy or range of management strategies that reflect moderate clinical certainty (ie, based on strength of evidence Class II studies that directly address the issue, decision analysis that directly addresses the issue, or strong consensus of strength of evidence Class III studies).

4. ACEP Clinical Policy Level C recommendations
Other strategies for patient management based on preliminary, inconclusive, or conflicting evidence, or in the absence of any published literature, based on panel consensus
Strength of evidence Class I
Interventional studies including clinical trials, observational studies including prospective cohort studies, aggregate studies including meta-analyses of randomized clinical trials only.

5. ACEP Clinical Policy Strength of evidence Class II
Observational studies including retrospective cohort studies, case-controlled studies, aggregate studies including other meta-analyses.
Strength of evidence Class III
Descriptive cross-sectional studies, observational reports including case series and case reports, consensus studies including published panel consensus by acknowledged groups of experts

6. ACEP Clinical Policy Total of 16 Recommendations
Only 1 Level A Recommendation
Total of 4 Level B Recommendations
Total of 11 Level C Recommendations

8. Definition
A technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function.
A suppressed level of consciousness that is adequate to allow the administration of painful or unpleasant diagnostic or therapeutic maneuvers in a way that minimizes patient awareness, discomfort, and memory, while attempting to preserve spontaneous respiration and airway-protective reflexes.

9. Definition Key point – Sedation is a Continuum Moderate sedation
previously referred to as ‘‘conscious sedation’’
defined as a drug-induced depression of consciousness during which patients respond purposefully.
Deep sedation
drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation.
These patients may require assistance in maintaining airway patency and ventilatory effort

10. Definition – Things to Remember
Procedural Sedation is a Continuum
Proper administration of sedative medications is a continuum
Individual response to medications is often difficult to predict
possess the skills required to rescue a patient 1 level greater than the intended level of sedation
Some suggest a separate category for dissociative agents

12. Preparation Proper personnel Monitoring Monitoring Respiratory Status
Patient Assessment
Fasting Status
Proper personnel
Proper Equipment
Monitoring
Monitoring Respiratory Status
Medication(s)

13. Patient Assessment Lack of outcome-based studies
Obtain a history and perform a physical examination to identify features that may affect procedural sedation and analgesia and airway management
Medical illnesses
Medications and allergies
Anatomic features
No routine diagnostic testing is required before procedural sedation.
(Level C recommendations)

14. Fasting Status
The combination of vomiting and loss of airway protective reflexes is an extremely rare occurrence with procedural sedation and analgesia, making aspiration an unlikely event
no uniformly accepted practice standards
Formal Recommendation (Level C)
Recent food intake is not a contraindication for administering procedural sedation and analgesia, but should be considered in choosing the timing and target level of sedation.

15. Proper Personnel Physician/staff knowledgeable in
Effects of the medication
Monitoring the patient’s response to medication
Managing complications
If physician involved in performing a procedure
Support personnel capable of monitoring patient
No clear evidence on the number of personnel necessary to safely provide procedural sedation and analgesia

16. Proper Personnel Formal Recommendation (Level C)
Procedural sedation and analgesia in the ED must be supervised by an emergency physician or other appropriately trained and credentialed specialist.
During moderate and deep sedation, a qualified support person should be present for continuous monitoring of the patient.

17. Proper Equipment
Although rare, procedural sedation and analgesia may result in an allergic reaction, respiratory arrest, or cardiopulmonary arrest.
Oxygen
Suction
Medications (naloxone, flumazenil, ACLS)
Advanced life support equipment (eg, a bag-mask ventilation device, and intubation equipment)
IV access (possible exception – Ketamine IM)

18. Equipment Formal Recommendations (Level C)
Oxygen, suction, reversal agents, and advanced life support medications and equipment should be available when procedural sedation and analgesia is used.
Intravenous access should be maintained when intravenous procedural sedation and analgesia is provided. Intravenous access may not be necessary when procedural sedation and analgesia is provided by other routes.

20. Monitoring Vital signs Ability to respond to verbal stimuli
BP, Pulse, Respiratory Rate, Pulse Oximetry
Ability to respond to verbal stimuli
Should be documented before, during, after
Medication and amount used
Remember, over 90% of adverse events occur during the procedure
Median time – 2 mins after last med dose

21. Preparation Monitoring Formal Recommendation (Level C)
Obtain and document vital signs before, during, and after procedural sedation and analgesia. Monitor the patient’s appearance and ability to respond to verbal stimuli during and after procedural sedation and analgesia.

22. Monitoring Respiratory Status
Pulse Oximetry
Good correlation with PaO2
Does not correlate with hypoventilation
Desaturation can be delayed by supplemental oxygen in the face of hypoventilation
Capnometry
May be able to detect hypoventilation before desaturation
No evidence of impact on patient outcome
If used, look for >50 or change of >10 from baseline

23. Monitoring Respiratory Status
Level B Recommendation
Pulse oximetry should be used in patients at increased risk of developing hypoxemia, such as when high doses of drugs or multiple drugs are used, or when treating patients with significant comorbidity
Level C Recommendations
When the patient’s level of consciousness is minimally depressed and verbal communication can be continually monitored, pulse oximetry may not be necessary.
Consider capnometry to provide additional information regarding early identification of hypoventilation

24. Tribute to Rob: Name this Nintendo Game

25. Medications Ideal Agent
Provides both ANALGESIA and AMNESIA
Rapid onset
Short duration
Rapid recovery
Titrate Medication dose to desired effect (Level B Recommendation)
Fast administration increases risk of hypotension or respiratory depression
If using both a benzodiazepine and an opioid, it is suggested the opioid should be given first and the benzodiazepine dose titrated

26. Medications
Use of drugs in combination may accentuate the potential side effects associated with each drug individually
In 1 study, use of versed alone resulted in no significant respiratory depression
Use of fentanyl alone caused hypoxemia in 50% and caused a decrease in ventilatory response to carbon dioxide, but did not cause apnea
When versed and fentanyl were used together, hypoxemia occurred in 92% of subjects, and apnea occurred in 50%.

27. Medications
Ketamine
Causes dissociative state in which a patient may not speak or respond purposefully to verbal commands
Use of ketamine in the doses recommended for procedural sedation and analgesia does not result in a loss of protective reflexes
In a consecutive case series of 1,022 children, Green et al report that ketamine at doses of 4 to 5 mg/kg intramuscularly produced adequate sedation in 98% of children.

28. Medications
Ketamine
Airway complications occurred in 1.4% of patients including laryngospasm, apnea, and respiratory depression, all of which were quickly identified and treated without intubation or sequelae.
Emesis occurred in 6.7% without evidence of aspiration.
Formal Recommendation Level A - Ketamine can be safely administered to children for procedural sedation and analgesia in the ED

29. As my friend Justin has pointed out, 'due to the alarming rise in humans partaking of ketamine, the black metal-enhancing drug which rightfully belongs to horses, the equine kingdom has decided to wreak its boozy revenge':                                               

30. More on Ketamine Ketamine IV or IM?
4mg/kg IM (max 200mg) vs 1mg/kg IV (max 100mg)
Both given with glycopyrrolate
5mcg/kg max dose 250mcg
Other studies suggest 1.5mg/kg IV more appropriate loading dose
27% IV pt’s required multiple dosing
Only 9% IM pt’s
8.3% IV pt’s desaturated
Only 4% IM pt’s desaturated

31. More on Ketamine More IM pt’s vomited (35% vs 20%)
IM Pt’s reported less pain
Effective Dissociation longer in IM pt’s
20-30 mins vs 5-10
Length of sedation longer in IM pt’s
Median 129 minutes vs 80
Up to 365 minutes in IM group
Study stopped early at nursing request due to increased length of recovery and increased rates of vomiting

32. More on Ketamine Conclusion – IM or IV? IV (1.5mg/kg) IM (4mg/kg)
If already have an IV established
5-10 minute procedure planned
Planning procedure longer than 20 minutes so that repeat doses may be given
IM (4mg/kg)
No IV access
Planned procedure likely to take minutes and you don’t want to repeat dose

34. Propofol Diprivan Hotly Contested Medication
1% propofol, 10% soybean oil and 1.2% purified egg phospholipid (emulsifier), with 2.25% of glycerol as a tonicity adjusting agent, and sodium hydroxide to adjust the pH
Uncertain mechanism of action
Hotly Contested Medication
See “Poachers and Dabblers?”: ASA President’s Incautious Comment Riles Emergency Physicians, Annals of Emergency Medicine, Volume 50, Issue 3, Pages (September 2007)

35. Propofol Standard Dose – 1mg/kg IV Rapid Onset of action – 45 seconds
Repeat dose 0.5mg/kg IV
Rapid Onset of action – 45 seconds
Good amnesia
Return to baseline function after completion of procedure
7 minutes

36. Propofol Study looking at propofol vs etomidate
Increased subclinical respiratory depression
42% vs 34%
Oxygen Desaturation
9.1% vs 9.5%
Airway Repositioning
11% vs 13.3%
Required BVM
4.6% vs 3.8%
Decreased SBP from baseline
7.9mm vs 3.8mm

37. Propofol Conclusion - Level B Recommendation Myoclonus*
1.8% vs 20%
Time to return of baseline*
6.8 mins vs 8.8 mins
Equally high level of patient satisfaction
Doses used
Propofol 1mg/kg then 0.5mg/kg q3 mins prn
Etomidate 0.1mg/kg then 0.05mg/kg q3-5 prn
Conclusion - Level B Recommendation
Propofol can be safely administered for procedural sedation and analgesia in the ED

39. Ketofol Ketamine and propofol in same syringe in 1:1 mixture
5mg/mL for each drug
Typical dose – 0.75mg/kg of each
100Kg person – 15mL
Median Recovery – 15 minutes
Adverse events – respiratory depression, emergence phenomenon

40. Ketofol
Friedberg used prospectively on 1264 pt’s in office based study
Annals January 2007 – 114 pts
Avg BP increased
Median decrease in O2 Sat – 2%
6 pts had hypoxia
3 required airway repositioning
1 required BVM for 2 minutes
3 pts had dysphoria
2 mild, 1 required versed
No vomiting

42. Etomidate Sedative hypnotic – GABA receptor Hemodynamically Stable
Rapid onset – <1 minute
Short duration of effect
3-5 minutes without redosing
Rapid Recovery
Dose Dependent
About 10 minutes for 0.1 – 0.15 mg/kg

43. Etomidate Myoclonus – 20% Desaturation
Overall – High level of patient satisfaction
114/120 pts would agree to use again
Level C Recommendation
Etomidate can be safely administered for procedural sedation and analgesia in the ED

44. Name the Movie

45. Brevital (methohexital)
Barbiturate, acts on GABA receptors
Introduced in early 1960’s
Published study looking at ED use in 1991
Hemodynamically Stable
Avg 1.8mm drop in SBP
Rapid Onset – about 1 minute
Short duration – about 8 minutes
Good amnesia

46. Brevital Respiratory depression is biggest drawback
22% required BVM
Pulse oximetry only used on 19/102 pts
Typical dose for procedural sedation is mg/kg
No formal recommendations given

47. Versed/Fentanyl Initial dose Falling out of favor in research articles
100mcg/kg fentanyl given first
0.1mg/kg versed bolus then titrate
Falling out of favor in research articles
Longer time of recovery
72 minutes
Other variants: versed/dilaudid, versed/morphine, versed/demerol
Provides both analgesia and amnesia

48. Versed/Fentanyl Available in most ED’s
Reversal agents readily available
Level B Recommendation
The combination of fentanyl and midazolam is effective for procedural sedation and analgesia in the ED.

50. Summary of Key Points Procedural Sedation is a continuum
Difference between moderate and deep sedation is responsiveness
Preparation is Key
Assess the Patient – H&P
Fasting Status – no evidence to support
Proper personnel
At least one person qualified to monitor patient

51. Summary of Key Points Proper equipment Monitoring
Monitor, Pulse ox, Oxygen, BVM, Suction, ACLS and Reversal Medications
Crash cart, intubation equipment available but not necessarily at the bed side
Monitoring
Someone needs to monitor vitals, appearance, responsiveness, drugs given
Before, during, and after procedure
Continuous pulse ox
Consider capnometry

52. Summary of Key Points Titrate medications to effect
Slower administration shows fewer adverse effects
Be prepared to handle 1 level deeper than your target level of sedation