A. Anesthesia

Deep Sedation/General Anesthesia

Subject: III. Clinical - A. Anesthesia

Department: Clinical Affairs

Origination Date: December 4, 2013

Reviewed and/or Revised: 09/01/2017, 05/16/2022, 9/27/2023, 02/05/2024, 09/18/2024

Purpose: Safe use of deep sedation/ general anesthesia

Definitions:

Deep sedation – 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.

General anesthesia – a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug- induced depression of neuromuscular function. Cardiovascular function may be impaired.

Because sedation and general anesthesia are a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to diagnose and manage the physiologic consequences (rescue) for patients whose level of sedation becomes deeper than initially intended.

Policy and/or Procedure: Deep Sedation or General Anesthesia

1. Patient Evaluation

Patients considered for deep sedation or general anesthesia must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this must consist of at least a review of their current medical history and medication use and NPO status. However, patients with significant medical considerations (e.g., ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.

2. Pre-operative Preparation

The patient, parent, guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative or anesthetic agents and informed consent for the proposed sedation/anesthesia must be obtained.
Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed.
Baseline vital signs must be obtained unless the patient’s behavior prohibits such determination.
A focused physical evaluation must be performed as deemed appropriate.
Preoperative dietary restrictions must be considered based on the sedative/anesthetic technique prescribed.
Pre-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.
An intravenous line, which is secured throughout the procedure, must be established except as provided in part IV. C.6. Pediatric and Special Needs Patients.

3. Personnel and Equipment Requirements

Personnel: A minimum of three (3) individuals must be present.

A dentist qualified in accordance with part III. C. of the ADA Guidelines for the Use of Sedation and General Anesthesia by Dentists (as adopted by the October 2007 ADA House of Delegates) to administer the deep sedation or general anesthesia.
Two additional individuals who have current certification of successfully completing a Basic Life Support (BLS) Course for the Healthcare Provider.
When the same individual administering the deep sedation or general anesthesia is performing the dental procedure, one of the additional appropriately trained team members must be designated for patient monitoring.

Equipment:

A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm.
An appropriate scavenging system must be available if gases other than oxygen or air are used.
The equipment necessary to establish intravenous access must be available.
Equipment and drugs necessary to provide advanced airway management, and advanced cardiac life support must be immediately available.
If volatile anesthetic agents are utilized, an inspired agent analysis monitor and capnograph must be used. A protocol for an MH emergency with appropriate medications must be immediately available.
Resuscitation medications and an appropriate defibrillator must be immediately available.

4. Monitoring and Documentation

Monitoring: A qualified dentist administering deep sedation or general anesthesia must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring must include:

Oxygenation:
- Color of mucosa, skin or blood must be continually evaluated.
- Oxygenation saturation must be evaluated continuously by pulse oximetry.
Ventilation:
- Intubated patient: End-tidal CO2 must be continuously monitored and evaluated.
- Non-intubated patient: Breath sounds via auscultation and/or end-tidal CO2 must be continually monitored and evaluated.
- Respiration rate must be continually monitored and evaluated.
Circulation:
- The dentist must continuously evaluate heart rate and rhythm via ECG throughout the procedure, as well as pulse rate via pulse oximetry.
- The dentist must continually evaluate blood pressure.
Temperature:
- A device capable of measuring body temperature must be readily available during the administration of deep sedation or general anesthesia.
- The equipment to continuously monitor body temperature should be available and must be performed whenever triggering agents associated with malignant hyperthermia are administered.

Documentation:

Appropriate time-oriented anesthetic record must be maintained, including the names of all drugs administered, including local anesthetics, doses and monitored physiological parameters.
Pulse oximetry and end-tidal CO2 measurements (if taken), heart rate, respiratory rate and blood pressure must be recorded at appropriate intervals.

5. Recovery and Discharge

Oxygen and suction equipment must be immediately available if a separate recovery area is utilized.
The dentist or clinical staff must continually monitor the patient’s blood pressure, heart rate, oxygenation and level of consciousness.
The dentist must determine and document that level of consciousness; oxygenation, ventilation and circulation are satisfactory for discharge.
Post-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.

6. Pediatric and Special Needs Patients

Because many dental patients undergoing deep sedation or general anesthesia are mentally and/or physically challenged, it is not always possible to have a comprehensive physical examination or appropriate laboratory tests prior to administering care. When these situations occur, the dentist responsible for administering the deep sedation or general anesthesia should document the reasons preventing the recommended preoperative management. In selected circumstances, induction of deep sedation or general anesthesia may be utilized without establishing an indwelling intravenous line. These selected circumstances may include very

Brief procedures or periods of time, which, for example, may occur in some pediatric or adult patients with special needs. The establishment of intravenous access may occur after deep sedation or general anesthesia has been induced because of poor patient cooperation.

7. Emergency Management

The qualified dentist is responsible for sedative/anesthetic management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of deep sedation or general anesthesia and providing the equipment, drugs and protocols for patient rescue.

IV Moderate Sedation

Subject: III. Clinical - A. Anesthesia

Department: Clinical Affairs

Origination Date: December 4, 2013

Effective Date: December 4, 2013

Reviewed and/or Revised: 09/01/2017, 05/16/2022, 09/27/2023, 02/28/2024, 09/18/2024

Purpose: Safe use of Oral/ IV moderate sedation

Definitions:

Moderate Sedation – a drug-induced depression of consciousness during which 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.2

Note: In accord with this particular definition, the drugs and/or techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely. Repeated dosing of an agent before the effects of previous dosing can be fully appreciated may result in a greater alteration of the state of consciousness than is the intent of the dentist. Further, a patient whose only response is reflex withdrawal from a painful stimulus is not considered to be in a state of moderate sedation.

The following definition applies to the administration of moderate or greater sedation:

titration – administration of incremental doses of a drug until a desired effect is reached. Knowledge of each drug’s time of onset, peak response and duration of action is essential to avoid over sedation. Although the concept of titration of a drug to effect is critical for patient safety, when the intent is moderate sedation one must know whether the previous dose has taken full effect before administering an additional drug increment.

Policy and/or Procedure: Moderate Sedation

1. Patient Evaluation

Patients considered for moderate sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this should consist of at least a review of their current medical history and medication use. However, patients with significant medical considerations (e.g., ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.

2. Pre-operative Preparation

The patient, parent, guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained.
Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed.
Baseline vital signs must be obtained unless the patient’s behavior prohibits such determination.
A focused physical evaluation must be performed as deemed appropriate.
Preoperative dietary restrictions must be considered based on the sedative technique prescribed.
Pre-operative verbal or written instructions must be given to the patient, parent, escort, guardian or care giver.

3. Personnel and Equipment Requirements

Personnel:

At least one additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist.

Equipment:

A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm.
An appropriate scavenging system must be available if gases other than oxygen or air are used.
The equipment necessary to establish intravenous access must be available.

4. Monitoring and Documentation

Monitoring: A qualified dentist administering moderate sedation must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. When active treatment concludes, and the patient recovers to a minimally sedated level a qualified auxiliary may be directed by the dentist to remain with the patient and continue to monitor them as explained in the guidelines until they are discharged from the facility. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring must include:

Consciousness:
- Level of consciousness (e.g., responsiveness to verbal command) must be continually assessed.
Oxygenation:
- Color of mucosa, skin or blood must be evaluated continually.
- Oxygen saturation must be evaluated by pulse oximetry continuously.
Ventilation:
- The dentist must observe chest excursions continually.
- The dentist must monitor ventilation. This can be accomplished by auscultation of breath sounds, monitoring end-tidal CO2 or by verbal communication with the patient.
Circulation:
- The dentist must continually evaluate blood pressure and heart rate (unless the patient is unable to tolerate, and this is noted in the time-oriented anesthesia record).
- Continuous ECG monitoring of patients with significant cardiovascular disease should be considered.

Documentation:

Appropriate time-oriented anesthetic record must be maintained, including the names of all drugs administered, including local anesthetics, dosages and monitored physiological parameters.
Pulse oximetry, heart rate, respiratory rate and blood pressure must be recorded continually.

5. Recovery and Discharge

Oxygen and suction equipment must be immediately available if a separate recovery area is utilized.
The qualified dentist or appropriately trained clinical staff must continually monitor the patient’s blood pressure, heart rate, oxygenation and level of consciousness.
The qualified dentist must determine and document that level of consciousness; oxygenation, ventilation and circulation are satisfactory for discharge.
Post-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.
If a reversal agent is administered before discharge criteria have been met, the patient must be monitored until recovery is assured.

6. Emergency Management

If a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient returns to the intended level of sedation.

The qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of moderate sedation and providing the equipment, drugs and protocol for patient rescue.

7. Management of Children

For children 12 years of age and under, the American Dental Association supports the use of the American Academy of Pediatrics/American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.

Oral Anxiolysis, Minimal Sedation, and Nitrous Oxide

Subject: III. Clinical - A. Anesthesia

Department: Clinical Affairs

Origination Date: 12/04/2013

Reviewed and/or Revised: 09/01/2017, 05/16/2022, 09/27/2023, 02/20/2024, 09/18/2024

Purpose: To ensure safe use of Oral anxiolysis/minimal sedation, and Nitrous Oxide

Definitions:

Minimal Sedation – a minimally depressed level of consciousness, produced by a pharmacological method, that retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected.

Note: In accord with this particular definition, the drug(s) and/or techniques used should carry a margin of safety wide enough never to render unintended loss of consciousness. Further, patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of minimal sedation.

When the intent is minimal sedation for adults, the appropriate initial dosing of a single enteral drug is no more than the maximum recommended dose (MRD) of a drug that can be prescribed for unmonitored home use.

The use of preoperative sedatives for children (aged 12 and under) except in extraordinary situations must be avoided due to the risk of unobserved respiratory obstruction during transport by untrained individuals.

Children (aged 12 and under) can become moderately sedated despite the intended level of minimal sedation; should this occur, the guidelines for moderate sedation apply.

Nitrous oxide/oxygen may be used in combination with a single enteral drug in minimal sedation.

Nitrous oxide/oxygen when used in combination with sedative agent(s) may produce minimal, moderate, deep sedation or general anesthesia.

1 Portions excerpted from Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia , 2004, of the American Society of Anesthesiologists (ASA). A copy of the full text can be obtained from ASA, 520 N. Northwest Highway, Park Ridge, IL 60068-2573.

The following definitions apply to administration of minimal sedation:

maximum recommended (MRD) – maximum FDA-recommended dose of a drug, as printed in FDA-approved labeling for unmonitored home use.

incremental dosing – administration of multiple doses of a drug until a desired effect is reached, but not to exceed the maximum recommended dose (MRD).

supplemental dosing - during minimal sedation, supplemental dosing is a single additional dose of the initial dose of the initial drug that may be necessary for prolonged procedures. The supplemental dose should not exceed one-half of the initial dose and should not be administered until the dentist has determined the clinical half-life of the initial dosing has passed. The total aggregate dose must not exceed 1.5x the MRD on the day of treatment.

Anxiolysis.

A permit is not required for a dentist to administer anxiolysis.
A dentist who intends to administer anxiolysis shall indicate the intent to administer anxiolysis in the patient's records.
A dentist who administers anxiolysis may not administer a dose that is inappropriate for a patient's:
(1) Age; (2) Weight; (3) Medical condition; (4) Infirmities; or (5) Other propensities.
Medications used to produce anxiolysis may not exceed current limits set by the manufacturer for unmonitored use by the individual.
A dentist who administers anxiolysis shall maintain a margin of safety and a level of consciousness that does not approach moderate sedation and other deeper states of sedation and general anesthesia.

Policy and/or Procedure:

1. Nitrous oxide use must be approved by attending/covering faculty who must also be present in close proximity during use.

To administer minimal sedation the dentist must have successfully completed:
1. training to the level of competency in minimal sedation consistent with that prescribed in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students, or a comprehensive training program in moderate sedation that satisfies the requirements described in the Moderate Sedation section of the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students at the time training was commenced,
  or
2. an advanced education program accredited by the ADA Commission on Dental Accreditation that affords comprehensive and appropriate training necessary to administer and manage minimal sedation commensurate with these guidelines;
  and
3. a current certification in Basic Life Support for Healthcare Providers.
Administration of minimal sedation by another qualified dentist or independently practicing qualified anesthesia healthcare provider requires the operating dentist and his/her clinical staff to maintain current certification in Basic Life Support for Healthcare Providers.

2. Patient Evaluation

Patients considered for minimal sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this may consist of a review of their current medical history and medication use. However, patients with significant medical considerations (ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.

3. Pre-Operative Preparation

The patient, parent, guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained.
Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed.
Baseline vital signs must be obtained unless the patient’s behavior prohibits such determination.
A focused physical evaluation must be performed as deemed appropriate.
Preoperative dietary restrictions must be considered based on the sedative technique prescribed.
Pre-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.

4. Personnel and Equipment Requirements

Personnel:

At least one additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist.

Equipment:

A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm.
An appropriate scavenging system must be available if gases other than oxygen or air are used.

5. Monitoring and Documentation

Monitoring: A dentist, or at the dentist’s direction, an appropriately trained individual, must remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:

Oxygenation:
- Color of mucosa, skin or blood must be evaluated continually.
- Oxygen saturation by pulse oximetry may be clinically useful and should be considered.
Ventilation:
- The dentist and/or appropriately trained individual must observe chest excursions continually.
- The dentist and/or appropriately trained individual must verify respirations continually.
Circulation:
- Blood pressure and heart rate should be evaluated pre-operatively, post-operatively and intra-operatively as necessary (unless the patient is unable to tolerate such monitoring).

Documentation: An appropriate sedative record must be maintained, including the names of all drugs administered, including local anesthetics, dosages, and monitored physiological parameters.

6. Recovery and Discharge

Oxygen and suction equipment must be immediately available if a separate recovery area is utilized.
The qualified dentist or appropriately trained clinical staff must monitor the patient during recovery until the patient is ready for discharge by the dentist.
The qualified dentist must determine and document that level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge.
Post-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.

7. Emergency Management

If a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient returns to the intended level of sedation.

The qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of minimal sedation and providing the equipment and protocols for patient rescue.

8. Management of Children

A. Anesthesia

Deep Sedation/General Anesthesia

IV Moderate Sedation

Oral Anxiolysis, Minimal Sedation, and Nitrous Oxide

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