Moderate Procedural Sedation and Analgesia

• Review previous medical records and interview the patient or family to identify:

  • Abnormalities of the major organ systems (e.g., cardiac, renal, pulmonary, neurologic, sleep apnea, metabolic, endocrine)

  • Adverse experience with sedation/analgesia, as well as regional and general anesthesia

  • History of a difficult airway

  • Current medications, potential drug interactions, drug allergies, and nutraceuticals

  • History of tobacco, alcohol or substance use or abuse

  • Frequent or repeated exposure to sedation/analgesic agents

• Conduct a focused physical examination of the patient (e.g., vital signs, auscultation of the heart and lungs, evaluation of the airway, and when appropriate to sedation, other organ systems where major abnormalities have been identified)

• Review available laboratory test results

  • Order additional laboratory tests guided by a patient’s medical condition, physical examination, and the likelihood that the results will affect the management of moderate sedation/analgesia

  • Evaluate results of these tests before sedation is initiated

• If possible, perform the preprocedure evaluation well enough in advance (e.g., several days to weeks) to allow for optimal patient preparation

• Reevaluate the patient immediately before the procedure.

• Consult with a medical specialist (e.g., physician anesthesiologist, cardiologist, endocrinologist, pulmonologist, nephrologist, pediatrician, obstetrician, or otolaryngologist), when appropriate before administration of moderate procedural sedation to patients with significant underlying conditions

  • If a specialist is needed, select a specialist based on the nature of the underlying condition and the urgency of the situation

  • For severely compromised or medically unstable patients (e.g., ASA status IV, anticipated difficult airway, severe obstructive pulmonary disease, coronary artery disease, or congestive heart failure) or if it is likely that sedation to the point of unresponsiveness will be necessary to obtain adequate conditions, consult with a physician anesthesiologist

• Before the procedure, inform patients or legal guardians of the benefits, risks, and limitations of moderate sedation/analgesia and possible alternatives, and elicit their preferences

• Inform patients or legal guardians before the day of the procedure that they should not drink fluids or eat solid foods for a sufficient period of time to allow for gastric emptying before the procedure

• On the day of the procedure, assess the time and nature of last oral intake

  • Evaluate the risk of pulmonary aspiration of gastric contents when determining (1) the target level of sedation and (2) whether the procedure should be delayed

• In urgent or emergent situations where complete gastric emptying is not possible, do not delay moderate procedural sedation based on fasting time alone

Monitoring Patient Level of Consciousness

• Periodically (e.g., at 5-min intervals) monitor a patient’s response to verbal commands during moderate sedation, except in patients who are unable to respond appropriately (e.g., patients where age or development may impair bidirectional communication) or during procedures where movement could be detrimental

• During procedures where a verbal response is not possible (e.g., oral surgery, restorative dentistry, upper endoscopy), check the patient’s ability to give a “thumbs up” or other indication of consciousness in response to verbal or tactile (light tap) stimulation; this suggests that the patient will be able to control his airway and take deep breaths if necessary

Monitoring Patient Ventilation and Oxygenation

• Continually monitor ventilatory function by observation of qualitative clinical signs

• Continually monitor ventilatory function with capnography unless precluded or invalidated by the nature of the patient, procedure, or equipment

  • For uncooperative patients, institute capnography after moderate sedation has been achieved

• Continuously monitor all patients by pulse oximetry with appropriate alarms

Monitoring Hemodynamics

• Determine blood pressure before sedation/analgesia is initiated unless precluded by lack of patient cooperation

• Once moderate sedation/analgesia is established, continually monitor blood pressure (e.g., at 5-min intervals) and heart rate during the procedure unless such monitoring interferes with the procedure (e.g., magnetic resonance imaging where stimulation from the blood pressure cuff could arouse an appropriately sedated patient)

• Use electrocardiographic monitoring during moderate sedation in patients with clinically significant cardiovascular disease or those who are undergoing procedures where dysrhythmias are anticipated

Contemporaneous Recording of Monitored Parameters

• Record patients’ level of consciousness, ventilatory and oxygenation status, and hemodynamic variables at a frequency that depends on the type and amount of medication administered, the length of the procedure, and the general condition of the patient

  • At a minimum, this should occur: (1) before the administration of sedative/analgesic agents, (2) after administration of sedative/analgesic agents, (3) at regular intervals during the procedure, (4) during initial recovery, and (5) just before discharge

• Set device alarms to alert the care team to critical changes in patient status

Availability of an Individual Responsible for Patient Monitoring

• Assure that a designated individual other than the practitioner performing the procedure is present to monitor the patient throughout the procedure

  • The individual responsible for monitoring the patient should be trained in the recognition of apnea and airway obstruction and be authorized to seek additional help

  • The designated individual may assist with minor, interruptible tasks once the patient’s level of sedation/analgesia and vital signs have stabilized, provided that adequate monitoring for the patient’s level of sedation is maintained

Supplemental Oxygen

• Use supplemental oxygen during moderate procedural sedation/analgesia unless specifically contraindicated for a particular patient or procedure

Emergency Support

• Assure that pharmacologic antagonists for benzodiazepines and opioids are immediately available in the procedure suite or procedure room

• Assure that an individual is present in the room who understands the pharmacology of the sedative/analgesics administered (e.g., opioids and benzodiazepines) and potential interactions with other medications and nutraceuticals the patient may be taking

• Assure that appropriately sized equipment for establishing a patent airway is available

• Assure that at least one individual capable of establishing a patent airway and providing positive pressure ventilation is present in the procedure room

• Assure that suction, advanced airway equipment, a positive pressure ventilation device, and supplemental oxygen are immediately available in the procedure room and in good working order

  • Assure that a member of the procedural team is trained in the recognition and treatment of airway complications (e.g., apnea, laryngospasm, airway obstruction), opening the airway, suctioning secretions, and performing bag-valve-mask ventilation

• Assure that a member of the procedural team has the skills to establish intravascular access

• Assure that a member of the procedural team has the skills to provide chest compressions

• Assure that a functional defibrillator or automatic external defibrillator is immediately available in the procedure area

• Assure that an individual or service (e.g., code blue team, paramedic-staffed ambulance service) with advanced life support skills (e.g., tracheal intubation, defibrillation, resuscitation medications) is immediately available

• Assure that members of the procedural team are able to recognize the need for additional support and know how to access emergency services from the procedure room (e.g., telephone, call button)

Sedative or Analgesic Medications Not Intended for General Anesthesia

• Combinations of sedative and analgesic agents may be administered as appropriate for the procedure and the condition of the patient

  • Administer each component individually to achieve the desired effect (e.g., additional analgesic medication to relieve pain; additional sedative medication to decrease awareness or anxiety)

• Dexmedetomidine may be administered as an alternative to benzodiazepine sedatives on a case-by-case basis

• In patients receiving intravenous medications for sedation/analgesia, maintain vascular access throughout the procedure and until the patient is no longer at risk for cardiorespiratory depression

• In patients who have received sedation/analgesia by nonintravenous routes or whose intravenous line has become dislodged or blocked, determine the advisability of reestablishing intravenous access on a case-by-case basis

• Administer intravenous sedative/analgesic drugs in small, incremental doses, or by infusion, titrating to the desired endpoints

  • Allow sufficient time to elapse between doses so the peak effect of each dose can be assessed before subsequent drug administration

• When drugs are administered by nonintravenous routes (e.g., oral, rectal, intramuscular, transmucosal), allow sufficient time for absorption and peak effect of the previous dose to occur before supplementation is considered

Sedative/Analgesic Medications Intended for General Anesthesia

• When moderate procedural sedation with sedative/analgesic medications intended for general anesthesia by any route is intended, provide care consistent with that required for general anesthesia

• Assure that practitioners administering sedative/analgesic medications intended for general anesthesia are able to reliably identify and rescue patients from unintended deep sedation or general anesthesia

• For patients receiving intravenous sedative/analgesics intended for general anesthesia, maintain vascular access throughout the procedure and until the patient is no longer at risk for cardiorespiratory depression

• In patients who have received sedative/analgesic medications intended for general anesthesia by nonintravenous routes or whose intravenous line has become dislodged or blocked, determine the advisability of reestablishing intravenous access on a case-by-case basis

• Administer intravenous sedative/analgesic medications intended for general anesthesia in small, incremental doses, or by infusion, titrating to the desired endpoints

  • Allow sufficient time to elapse between doses so the peak effect of each dose can be assessed before subsequent drug administration

• When drugs intended for general anesthesia are administered by nonintravenous routes (e.g., oral, rectal, intramuscular, transmucosal), allow sufficient time for absorption and peak effect of the previous dose to occur before supplementation is considered

Reversal Agents

• Assure that specific antagonists are immediately available in the procedure room whenever opioid analgesics or benzodiazepines are administered for moderate procedural sedation/analgesia, regardless of route of administration

• If patients develop hypoxemia, significant hypoventilation or apnea during sedation/analgesia: (1) encourage or physically stimulate patients to breathe deeply, (2) administer supplemental oxygen, and (3) provide positive pressure ventilation if spontaneous ventilation is inadequate

• Use reversal agents in cases where airway control, spontaneous ventilation, or positive pressure ventilation is inadequate

  • Administer naloxone to reverse opioid-induced sedation and respiratory depression

  • Administer flumazenil to reverse benzodiazepine-induced sedation and respiratory depression

• After pharmacologic reversal, observe and monitor patients for a sufficient time to ensure that sedation and cardiorespiratory depression does not recur once the effect of the antagonist dissipates

• Do not use sedation regimens that are intended to include routine reversal of sedative or analgesic agents
  

Recovery Care

• After sedation/analgesia, observe and monitor patients in an appropriately staffed and equipped area until they are near their baseline level of consciousness and are no longer at increased risk for cardiorespiratory depression

• Monitor oxygenation continuously until patients are no longer at risk for hypoxemia

Creation and Implementation of Patient Safety Processes

• Create and implement a quality improvement process based upon established national, regional, or institutional reporting protocols (e.g., adverse events, unsatisfactory sedation)

  • Periodically update the quality improvement process to keep up with new technology, equipment or other advances in moderate procedural sedation/analgesia

• Strengthen patient safety culture through collaborative practices (e.g., team training, simulation drills, development and implementation of checklists)

• Create an emergency response plan (e.g., activating “code blue” team or activating the emergency medical response system: 911 or equivalent)

• Monitor ventilation and circulation at regular intervals (e.g., every 5 to 15 min) until patients are suitable for discharge

• Design discharge criteria to minimize the risk of central nervous system or cardiorespiratory depression after discharge from observation by trained personnel