Conscious sedation

# Assessment

## ASA Physical Status Classification

### Assessed and recorded by Operator
- Class I: There is no organic, physiological, biochemical or psychiatric disturbance. The pathologic process for which the procedure is to be performed is localized and not a systemic disturbance.
- Class II: Mild to moderate systemic disturbance caused by the condition to be treated procedurally or by other pathophysiological processes.
- 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 procedure.
An anesthesia consult should be strongly considered.
- Class V: The moribund patient who has little chance of survival but is submitted to the procedure in desperation.
If not an emergency, requires an anesthesia consult.

### Patient Assessment by M.D. and R.N.
- Medical history; concurrent medical problems
- Physical assessment esp. airway, chest & cardiac
- Current medications and medication allergies
- Baseline vital signs, height, weight
- Level of consciousness, ability to cooperate
- Ability to communicate
- Ability to tolerate positioning
- General physical condition
- ASA classification (>4 requires anesthesia consult)
- At Risk
Anesthesia Consult Considered
Limited Head/Neck ROM
Abnormal Cranio-Facial Anatomy
Morbid Obesity
Any other condition which might impede the procedure: sleep apnea, severe pain, problematic body habitus
Anesthesia Consult Required
ASA class 5
Hx Fiberoptic Intubation
Mallampati III
Hx of Difficult  or Failed Intubation
Hi Risk : additional personnel are required
Procedure is particularly complex
Patients medical condition requires management beyond capacity of the practitioner(s)
- Anesthesia Consult Considered
Limited Head/Neck ROM
Abnormal Cranio-Facial Anatomy
Morbid Obesity
Any other condition which might impede the procedure: sleep apnea, severe pain, problematic body habitus
- Limited Head/Neck ROM
- Abnormal Cranio-Facial Anatomy
- Morbid Obesity
- Any other condition which might impede the procedure: sleep apnea, severe pain, problematic body habitus
- Anesthesia Consult Required
ASA class 5
Hx Fiberoptic Intubation
- ASA class 5
- Hx Fiberoptic Intubation
- Mallampati III
Hx of Difficult  or Failed Intubation
- Hx of Difficult  or Failed Intubation
- Hi Risk : additional personnel are required
Procedure is particularly complex
Patients medical condition requires management beyond capacity of the practitioner(s)
- Procedure is particularly complex
- Patients medical condition requires management beyond capacity of the practitioner(s)

## Recommended Aspects in Medical History
- Abnormalities of the major organs systems
- Previous adverse experience  with sedation/analgesia as well as regional anesthesia
- Drug allergies, current medications, and potential drug interactions
- Time and nature of last oral intake
- History of tobacco, alcohol or substance use or abuse
- Airway classification:
patient sitting upright and looking directly forward
-pens mouth and extends tongue
- patient sitting upright and looking directly forward
- opens mouth and extends tongue
- Class 1: uvula, faucial pillars, soft palate visible
- Class 2 : facial pillars, soft palate visible
- Class 3 : only soft palate visible (Anesthesia consult required)

## Procedure preparation
- Patients (or legal guardians in the case of minors or legally incompetent adults) should be informed of and agree to the administration of sedation/analgesia, including its benefits, risks, and limitations associated, as well as possible alternatives
- Patients undergoing sedation/analgesia for elective procedures should not drink fluids or eat solid foods for a period of time to allow for gastric emptying before their procedure
- In urgent, emergent, or other situations in which gastric emptying is impaired the potential for pulmonary aspiration of gastric contents must be considered in determining:
The target of level sedation
Whether the procedure should be delayed
Whether the trachea should be protected for intubation
- The target of level sedation
- Whether the procedure should be delayed
- Whether the trachea should be protected for intubation

### Preprocedure Fasting Guidelines
Ingested Material: Minimum Fasting Period*
Clear liquids: 2 h
Breast Formula: 4h
Infant Formula: 6h
Nonhuman milk: 6h
Light meal: 6h
These recommendations apply for healthy patients who are undergoing elective procedures
- The fasting periods apply to all ages

## Inform Consent
- Must include the risks and alternatives to IVCS and the procedure
- JCAHO standards: require patient involvement in pain management
- Consent for Procedure and other procedure-specific consent forms revised to include standardized IVCS information

# Personnel

## Number of Personnel
- Operator :(LIP- MD or DMD)credentialed to perform the procedure and credentialed to perform IVCS. Both sets are required to perform a procedure using IVCS
- Monitor : (licensed MD, RN, DMD, PA ,NP) shall have no other significant responsibilities which would compromise her/his ability to monitor the patient
- Other: (additional personnel PRN for High-Risk patients/procedures)

## Escentials of Training
- Operator:
Onsite and available from 1st dose through recovery
airway management
pharmacology of IVCS drugs
Understand the role of pharmacologic antagonists for opioids and benzodiazepines
- Onsite and available from 1st dose through recovery
- airway management
- pharmacology of IVCS drugs
- Understand the role of pharmacologic antagonists for opioids and benzodiazepines
- Monitor:
airway management
pharmacology of IVCS drugs
monitors appropriate Physiological parameters to procedure and IVCS
capable of assisting with resuscitative measures
completes Learning Module ( revalidated annually)
- airway management
- pharmacology of IVCS drugs
- monitors appropriate Physiological parameters to procedure and IVCS
- capable of assisting with resuscitative measures
- completes Learning Module ( revalidated annually)

# Monitoring

## Monitoring and Setting for IVCS
- Monitor and Document every 5-10 minutes
Blood Pressure
Heart Rate and Rhythm
Risk assessment drives monitoring parameters
Respiratory Rate: ventilation status
Oxygen Saturation
Sedation Scale
Pain Scale
- Blood Pressure
- Heart Rate and Rhythm
Risk assessment drives monitoring parameters
- Risk assessment drives monitoring parameters
- Respiratory Rate: ventilation status
- Oxygen Saturation
- Sedation Scale
- Pain Scale

## IVCS Setting
- Means to deliver PPV including Ambu w/ various mask sizes and airways
- Source of Suction w/ Yankauer and supplies
- Crash Cart & Defibrillator and means to contact emergency support posted
- Oxygen and O2 delivery supplies
- Blood Pressure & Stethoscope
- Cardiac Monitor w/ audible alarms
- Pulse Oximeter w/ audible alarms
- Pharmacological Reversal Agents

### Monitored Parameters
At a minimum, it should be:
- Before the beginning of the procedure
- After administration of sedative-analgesic agents
- At regular intervals during the procedure
- During initial recovery
- Just before discharge

## Intravenous Conscious Sedation Review(IVCS Review)
- Conducted prior to the procedure
- Assures IVCS is indicated and appropriate
state of consciousness and medical condition
pre-procedure consultations with appropriate specialists are strongly considered
prep studies for the procedure and the IVCS are completed
known allergies and sensitivity are documented
PMH and current drug regime obtained and reviewed
NPO for 6 hrs, except for clear liquids up to 2 hours prior to IVCS
Medications may be taken with a sip of water
Informed consent is validated
Discharge plans for ambulatory patients are reviewed
Immediately prior to the procedure; validation the the patients condition and the procedure plan have not changed
- state of consciousness and medical condition
- pre-procedure consultations with appropriate specialists are strongly considered
- prep studies for the procedure and the IVCS are completed
- known allergies and sensitivity are documented
- PMH and current drug regime obtained and reviewed
- NPO for 6 hrs, except for clear liquids up to 2 hours prior to IVCS
- Medications may be taken with a sip of water
- Informed consent is validated
- Discharge plans for ambulatory patients are reviewed
- Immediately prior to the procedure; validation the the patients condition and the procedure plan have not changed
- Physical exam has been conducted and includes
estimated weight
vital signs; baseline BP, HR, RR pattern and quality
baseline O2 saturation
airway assessment: evaluation performed in anticipation of possible need for PPV
head/neck rom, abnormal cranio-facial anatomy, Mallampati
pulmonary and cardiac status
general neurological status e.g., mental status, neurological deficits
ASA:  physical status classification
- estimated weight
- vital signs; baseline BP, HR, RR pattern and quality
- baseline O2 saturation
- airway assessment: evaluation performed in anticipation of possible need for PPV
head/neck rom, abnormal cranio-facial anatomy, Mallampati
- head/neck rom, abnormal cranio-facial anatomy, Mallampati
- pulmonary and cardiac status
- general neurological status e.g., mental status, neurological deficits
- ASA:  physical status classification
- Immediately Prior to Administration of IVCS:
The monitor/operator assures there is documentation the initial assessment and plan has not changed
Documented on Pre-IVCS review form by the Operator
Pre-IVCS conducted by an NP or PA must be co-signed by an IVCS credentialed MD who will be involved with the procedure.
The monitor obtains a baseline pre-sedation assessment
VS, O2 sat and O2 requirements, cardiac rhythm, loc, pain scale, sedation scale, patient ability to tolerate positioning required for procedure and recovery, confirms functioning IV, patient instructed to report problems with procedure or IVCS
- The monitor/operator assures there is documentation the initial assessment and plan has not changed
Documented on Pre-IVCS review form by the Operator
Pre-IVCS conducted by an NP or PA must be co-signed by an IVCS credentialed MD who will be involved with the procedure.
- Documented on Pre-IVCS review form by the Operator
- Pre-IVCS conducted by an NP or PA must be co-signed by an IVCS credentialed MD who will be involved with the procedure.
- The monitor obtains a baseline pre-sedation assessment
VS, O2 sat and O2 requirements, cardiac rhythm, loc, pain scale, sedation scale, patient ability to tolerate positioning required for procedure and recovery, confirms functioning IV, patient instructed to report problems with procedure or IVCS
- VS, O2 sat and O2 requirements, cardiac rhythm, loc, pain scale, sedation scale, patient ability to tolerate positioning required for procedure and recovery, confirms functioning IV, patient instructed to report problems with procedure or IVCS

## IVCS Record
- Prior to the procedure the Monitor will:
Validate that the Pre-IVCS review form has been signed and completed
Validate a signed written consent for the IVCS and Procedure
Conduct a pre-sedation review of the patients VS, O2 sat, sedation scale, pain scale,NPO status, airway assessment, discharge arrangements,cardiac rhythm, loc, presence of a patent IV, equipment safety check,ASA status
- Validate that the Pre-IVCS review form has been signed and completed
- Validate a signed written consent for the IVCS and Procedure
- Conduct a pre-sedation review of the patients VS, O2 sat, sedation scale, pain scale,NPO status, airway assessment, discharge arrangements,cardiac rhythm, loc, presence of a patent IV, equipment safety check,ASA status
- During the procedure: Monitor ascertains and records pts. response to IVCS and procedure
medications: drug name, time, dose, route, site
pain scale ( 1-10)  and sedation scale ( 0-4)
amount and means of O2
vital signs: BP, RR and quality, HR and level of responsiveness every 5-10 min. as warranted
continuous cardiac monitor: ASA > 3, hx. Of cardiac/pulmonary disease
continuous O2 stat, documented every 5-10 min.
check patients head position for patent airway
- medications: drug name, time, dose, route, site
pain scale ( 1-10)  and sedation scale ( 0-4)
- pain scale ( 1-10)  and sedation scale ( 0-4)
- amount and means of O2
- vital signs: BP, RR and quality, HR and level of responsiveness every 5-10 min. as warranted
continuous cardiac monitor: ASA > 3, hx. Of cardiac/pulmonary disease
- continuous cardiac monitor: ASA > 3, hx. Of cardiac/pulmonary disease
- continuous O2 stat, documented every 5-10 min.
- check patients head position for patent airway
- Following the Procedure: The Monitor:
ascertains and records physiological parameters every 10 minutes for a minimum 30 min. following the last dose of sedation
beyond this period, if stable, document these parameters every 15 minutes until patient returns to pre-procedure state
the patient MUST be observed for 30 min. following the procedure
reversal agents; extend recovery at least 2 hours
- ascertains and records physiological parameters every 10 minutes for a minimum 30 min. following the last dose of sedation
- beyond this period, if stable, document these parameters every 15 minutes until patient returns to pre-procedure state
- the patient MUST be observed for 30 min. following the procedure
- reversal agents; extend recovery at least 2 hours

# Sedative/analgesic agents

## IVCS Administration Guidelines
Approved by the Pharmacy and Therapeutics Committee
For Use by Non-Anesthesiologists
Close monitoring of Vital Signs per policy
All medications can be associated with
Respiratory Depression 
Hypotension 
Dizziness/Drowsiness 
Nausea/Vomiting

## IVCS Considerations
- Certain patients may not tolerate recommended doses
geriatric or debilitated
history or pulmonary or cardiac disease
history of hepatic or renal disease
known hypersensitivity or idiosyncratic reactions
known increased intracranial pressure
known debilitating neurological condition
Potential medication interactions: P450 system activation, proteins binding, acidosis
- geriatric or debilitated
- history or pulmonary or cardiac disease
- history of hepatic or renal disease
- known hypersensitivity or idiosyncratic reactions
- known increased intracranial pressure
- known debilitating neurological condition
- Potential medication interactions: P450 system activation, proteins binding, acidosis

## Combination of sedative-Analgesic Agents
- Combinations of sedative and analgesic may be administered as appropriate for the procedure being performed and the condition of the patient
- Ideally, each component should be administered  individually to achieve the desire effect
- Appropriate management of the dose of each component to avoid complications

## Titration of IV Sedative/Analgesic Medications
- Small and incremental doses of intravenous sedative/analgesic drugs until the desired level of sedation or analgesia is achieved is preferable than a single dose based on patient size, weight or age
- Incremental drug administration improves patient comfort and decreases risks

## Drugs NOT Permitted for Sedation
- Etomidate - ( Amidate )
- Fentanyl Oralet - Fentanyl Lollipop
- Fentanyl Transdermal- (Fentanyl Skin Patches)
- Ketamine- Ketaject or Ketaler
- Methohexital (Brevital)
- Neuromuscular Blocking Agents
- Propofol (Diprivan)
- Thiopental

## Sedative and Analgesic Medications
- Diazepam
- midazolam
- Morphine
- Fentanyl
Synthetic opioid
100 times more potent than morphine
Rapid onset of analgesia with short duration
Known side effects include bradycardia and stiff chest syndrome
Treatment: Neuromuscular Blocking Agents
Prepare for Intubation
Consider Narcan
Titrate to desired effect, repeat dose every 10 minutes to Maximum dose:  3mcg/kg/hr Initial
Initial Dose: 0.3mcg/kg - 1.4mcg/kg
Onset: Immediate; 1-2 minutes
Duration: 30-60 minutes
Dosage: 25-100 ug over 3 minutes
Reduce dose by 1/2 when given with benzos or to the elderly
Clearance: hepatic/renal
Precautions: bradydysrhythmias
Contraindications: hypersensitivity
Side Effects: muscle rigidity, bradycardia, nausea and vomiting
- Synthetic opioid
- 100 times more potent than morphine
- Rapid onset of analgesia with short duration
- Known side effects include bradycardia and stiff chest syndrome
- Treatment: Neuromuscular Blocking Agents
- Prepare for Intubation
- Consider Narcan
- Titrate to desired effect, repeat dose every 10 minutes to Maximum dose:  3mcg/kg/hr Initial
- Initial Dose: 0.3mcg/kg - 1.4mcg/kg
- Onset: Immediate; 1-2 minutes
- Duration: 30-60 minutes
- Dosage: 25-100 ug over 3 minutes
- Reduce dose by 1/2 when given with benzos or to the elderly
- Clearance: hepatic/renal
- Precautions: bradydysrhythmias
- Contraindications: hypersensitivity
- Side Effects: muscle rigidity, bradycardia, nausea and vomiting

## Reversal Agents
- Before or concomitantly with pharmacologic reversal, patients who become hypoxemic or apneic during the sedation/analgesia should:
Be encouraged to or stimulated to breath deeply
Receive supplemental oxygen
Receive positive pressure ventilation if spontaneous ventilation is inadequate
- Be encouraged to or stimulated to breath deeply
- Receive supplemental oxygen
- Receive positive pressure ventilation if spontaneous ventilation is inadequate
- Flumazenil (Romazicon)
Specific benzodiazepine receptor reversal agent
Reversal of benzodiazpaine induced respiratory depression
Administered IV only
Onset: 1 minute  Peak: 2-6 minutes
Clinical duration :45-90 min--respiratory depression may recur!!
Dosage:  0.2 to a max. dose of 1 mg administer in .2mg increments over 15 seconds may repeat in 45 seconds if initial response is inadequate and again in 1 min. intervals to 1mg
Max dose: 1mg/dose and 3 mg/hr
Clearance: Hepatic
Administer: Large vein - decrease pain on inj.
Monitor: Vital Signs and O2 saturation closely
Precautions: Benzo withdrawal induced seizures, re-sedation, head trauma w/ elevated ICP, concurrent neuromuscular blockers, drug/alcohol dependant pts., tricyclic antidepressant Rx.
Contraindications: hypersensitivity, benzo use for life-threatening conditions e.g., intracranial hypertension, status epilepticus
Side Effects: Seizures, dizziness /agitation
- Specific benzodiazepine receptor reversal agent
- Reversal of benzodiazpaine induced respiratory depression
- Administered IV only
- Onset: 1 minute  Peak: 2-6 minutes
- Clinical duration :45-90 min--respiratory depression may recur!!
- Dosage:  0.2 to a max. dose of 1 mg administer in .2mg increments over 15 seconds may repeat in 45 seconds if initial response is inadequate and again in 1 min. intervals to 1mg
- Max dose: 1mg/dose and 3 mg/hr
- Clearance: Hepatic
- Administer: Large vein - decrease pain on inj.
- Monitor: Vital Signs and O2 saturation closely
- Precautions: Benzo withdrawal induced seizures, re-sedation, head trauma w/ elevated ICP, concurrent neuromuscular blockers, drug/alcohol dependant pts., tricyclic antidepressant Rx.
- Contraindications: hypersensitivity, benzo use for life-threatening conditions e.g., intracranial hypertension, status epilepticus
- Side Effects: Seizures, dizziness /agitation
- Naloxone  (Narcan)
Specific receptor antagonist for opioid effects
Administered IV or IM
Clinical duration 30-45 min, respiratory depression may recur!
Administer every 2-3 minutes as needed to increase resp. rate and alertness
Dosage:  Dilute 0.4 mg ampule ( 1cc) with 9cc NS
Administer: 1 ml increments of dilution (.04mg)
Call for help if no response after 0.4 mg administered
Effective ONLY for resp. depression caused by opiates
Monitor VS closely
Onset:1 minute
Duration:1-4 hours (less for resp. depression) cannot reverse Naloxone
Clearance:Hepatic
Precautions: opiate dependence, hyper/hypotension, pulmonary edema, V. tach/fib., CVD, potential for elevated ICP
Contraindications: hypersensitivity
Side Effects: nausea/vomiting,hypertension, tachycardia, ventricular arrhythmia's, pulmonary edema
- Specific receptor antagonist for opioid effects
- Administered IV or IM
- Clinical duration 30-45 min, respiratory depression may recur!
- Administer every 2-3 minutes as needed to increase resp. rate and alertness
- Dosage:  Dilute 0.4 mg ampule ( 1cc) with 9cc NS
Administer: 1 ml increments of dilution (.04mg)
Call for help if no response after 0.4 mg administered
- Administer: 1 ml increments of dilution (.04mg)
- Call for help if no response after 0.4 mg administered
- Effective ONLY for resp. depression caused by opiates
- Monitor VS closely
- Onset:1 minute
- Duration:1-4 hours (less for resp. depression) cannot reverse Naloxone
- Clearance:Hepatic
- Precautions: opiate dependence, hyper/hypotension, pulmonary edema, V. tach/fib., CVD, potential for elevated ICP
- Contraindications: hypersensitivity
- Side Effects: nausea/vomiting,hypertension, tachycardia, ventricular arrhythmia's, pulmonary edema

## Drugs Modifications for AIDS Patients
- Protease inhibitors (Ritonovir, Aprotinin, Cox 2 inhibitors) alter cytochrome P-450 activity
- Reduces liver metabolism of Midazolam and Diazepam
- Increased plasma drug concentrations can occur with altered CNS effects
- Avoid benzodiazepines if possible or significantly reduce the dosage
- Lorazepam (Ativan) has a different  elimination pathway. Obtain an anesthesia consult

# Complications

## Reasons for Complications in IVCS
- Inappropriate patient selection
NPO status
Patient unable to tolerate positioning
Procedure requires more than conscious sedation
Patient Expectation
Unable or Unwilling to cooperate
Pain Management
Expanded scope and/or timeframe of procedure
- NPO status
- Patient unable to tolerate positioning
- Procedure requires more than conscious sedation
- Patient Expectation
- Unable or Unwilling to cooperate
- Pain Management
- Expanded scope and/or timeframe of procedure
- Unanticipated responses from patient or equipment
Team members unfamiliar with equipment
Plans for dealing with emergency situations not addressed
Team unfamiliar with medications and typical patient response
Unanticipated response to the procedure
Unanticipated medication interaction
- Team members unfamiliar with equipment
- Plans for dealing with emergency situations not addressed
- Team unfamiliar with medications and typical patient response
- Unanticipated response to the procedure
- Unanticipated medication interaction
- Overmedication
Loss of contact with the caregiver !
Agitation, irritability, non compliance
Airway Complications: Most common complication of IVCS
Loss of protective airway reflexes
Airway obstruction and apnea
Hypoxemia and hypercarbia
Hemodynamic instability
- Loss of contact with the caregiver !
- Agitation, irritability, non compliance
- Airway Complications: Most common complication of IVCS
Loss of protective airway reflexes
Airway obstruction and apnea
Hypoxemia and hypercarbia
- Loss of protective airway reflexes
- Airway obstruction and apnea
- Hypoxemia and hypercarbia
- Hemodynamic instability
- Unanticipated need for a more involved procedure

# Recovery Care

## Recovery Care Principles
- Medical supervision of recovery and discharge is the responsibility of the operating practitioner or a licensed physician
- Recovery area should be equipped with or have direct contact with monitoring and resuscitation equipment
- Patients receiving moderate sedation should be monitored until appropriate discharge criteria are satisfied
- Level of consciousness,  vital signs and oxygenation should be recorded at regular intervals
- A nurse or another individual trained to monitor patients and recognize complication should be in attendance until discharge criteria are fulfilled
- An individual capable of managing complications should be immediately available until discharge criteria are fulfilled.

## Guideline for Discharge
- Patients should be alert and oriented
- Vital signs should be stable and within acceptable limits
- Use of scoring systems may assist in documentation of fitness for discharge
- Sufficient time (up to 2 h) should have elapsed after the last administration of reversal agents to ensure that patients do not become resedated after reversal effects have worn off
- Outpatients should be discharged in the presence of a responsible adult who will accompany the home and be able to report any postprocedural complication
- Outpatients and their escorts should be provided with written instructions regarding postprocedure diet, medications, activities, and a phone number to be call in case of emergency

### IVCS Record
- Discharge Criteria: 10 point scale
VS stable w/in 20% of baseline: 2pts.
O2 sat stable w/in 2% of baseline: 2pts.
Swallow, cough, gag reflexes present to baseline: 1pt.
Patient alert or approp. to baseline:2pts.
Patient able to sit/walk approp. to baseline or procedure:2pts.
Minimal nausea and dizziness: 1pt.
- VS stable w/in 20% of baseline: 2pts.
- O2 sat stable w/in 2% of baseline: 2pts.
- Swallow, cough, gag reflexes present to baseline: 1pt.
- Patient alert or approp. to baseline:2pts.
- Patient able to sit/walk approp. to baseline or procedure:2pts.
- Minimal nausea and dizziness: 1pt.
- RN may discharge per criteria w/ written MD order
A score of 8 or greater required for RN discharge
A score of 7 or less requires the patient to be evaluated for discharge by a physician
Separate and additional criteria for discharge related to the procedure will also apply
- A score of 8 or greater required for RN discharge
- A score of 7 or less requires the patient to be evaluated for discharge by a physician
- Separate and additional criteria for discharge related to the procedure will also apply