This is the current release of the guideline.

Any disease or condition that requires minimal or moderate sedation/analgesia for diagnostic imaging, image-guided interventions, and radiation oncology procedures

To assist physicians in the safe administration of sedation/analgesia and monitoring of patients receiving sedation/analgesia outside the operating room

Adult patients who receive moderate sedation and pediatric patients who receive minimal or moderate sedation for diagnostic imaging, image-guided interventions, or radiation oncology procedures

Note: These guidelines specifically exclude the following: patients managed by the anesthesiology or critical care service, patients on mechanical ventilation, patients who are American Society of Anesthesiology (ASA) class V. See Appendix A of the original guideline document for ASA Physical Status Classification.

Not stated

The Medline literature search is based on keywords provided by the topic author. The two general classes of keywords are those related to the condition (e.g., ankle pain, fever) and those that describe the diagnostic or therapeutic intervention of interest (e.g., mammography, MRI).

The search terms and parameters are manipulated to produce the most relevant, current evidence to address the Practice Guideline or Technical Standard topic being reviewed or developed. Combining the clinical conditions and diagnostic modalities or therapeutic procedures narrows the search to be relevant to the topic. Exploding the term "diagnostic imaging" captures relevant results for diagnostic topics.

The following criteria/limits are used in the searches.

1. Articles that have abstracts available and are concerned with humans.
2. Restrict the search to the year prior to the last topic update or in some cases the author of the topic may specify which year range to use in the search. For new topics, the year range is restricted to the last 5 years unless the topic author provides other instructions.
3. May restrict the search to Adults only or Pediatrics only.
4. Articles consisting of only summaries or case reports are often excluded from final results. 

The search strategy may be revised to improve the output as needed.

The total number of source documents identified as the result of the literature search is not known.

Not applicable

Not stated

Recommendations are formulated through iterative review by committee, collaborating societies, and membership. Suggested recommendations are reviewed by the committee, and agreement is reached by consensus.

Not applicable

A formal cost analysis was not performed and published costs analyses were not reviewed.

Each practice guideline and technical standard, representing a policy statement by the American College of Radiology (ACR), has undergone a thorough consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council.

This guideline was revised collaboratively by the American College of Radiology (ACR) and the Society of Interventional Radiology (SIR) to assist physicians in the safe administration of sedation/analgesia and monitoring of patients receiving sedation/analgesia outside the operating room. Sedation/analgesia allows patients to tolerate diagnostic imaging, image-guided interventions, and radiation oncology procedures by relieving anxiety, discomfort, or pain. It facilitates and may optimize diagnostic imaging, image-guided interventions, and radiation oncology procedures that require patient cooperation.

Definitions

Minimal sedation or anxiolysis is defined by the Joint Commission and the American Society of Anesthesiologists (ASA) as "the administration of oral medications for the reduction of anxiety" and "a drug-induced state during which the patient responds normally to verbal commands." The ASA states further that "although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected." Examples of drugs administered orally that might be considered for this use are sedative-hypnotics, anxiolytics, benzodiazepines, antihistamines, and narcotics. Drugs may also be administered by a non-oral route.

Moderate sedation/analgesia is a minimally depressed level of consciousness induced by the administration of pharmacologic agents in which the patient retains a continuous and independent ability to maintain protective reflexes and a patent airway and to be aroused by physical or verbal stimulation.

Deep sedation/analgesia is 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 is a controlled state of unconsciousness in which there is a complete loss of protective reflexes, including the ability to maintain a patent airway independently and to respond appropriately to painful stimulation.

Regardless of the route of drug administration, administration of these medications may result in a level of sedation that is lighter than or deeper than the level intended for a patient. Sedation may result in the loss of the patient's protective reflexes. All sedated patients should be monitored and treated appropriately regardless of the intended level of sedation. The personnel and equipment considered appropriate for monitoring depend on the acuity level and potential response of the patient to the procedure or intervention proposed.

Scope

The monitoring guidelines in this guidance document apply to adult patients who receive moderate sedation and to pediatric patients who receive minimal or moderate sedation for diagnostic imaging, image-guided interventions, or radiation oncology procedures.

The administration of deep sedation/analgesia for more painful procedures requires a greater level of skill and experience and more intensive monitoring than is described here. Deep sedation is within the scope of practice of qualified interventional radiologists but is outside of the scope of this document.

Special consideration should be given to patients undergoing sedation in a magnetic resonance imaging (MRI) environment. Relevant issues are addressed by the ASA's Practice Advisory on Anesthetic Care for Magnetic Resonance Imaging.

Qualification and Responsibilities of Personnel

Sedation/analgesia should be administered under the supervision of a licensed physician. Appropriately trained medical personnel should be available to treat any adverse event. All persons administering and monitoring sedation are responsible for maintaining proficient skills necessary to provide quality patient care.

1. Supervising Physician

   The supervising physician should:

   1. Have sufficient knowledge of the pharmacology, indications, and contraindications for the use of sedative agents to enable safe administration and have the ability to recognize and initiate treatment for adverse reactions, including the use of reversal agents
   2. Have appropriate continuing education in accordance with the "ACR Practice Guideline for Continuing Medical Education (CME)" (see the ACR Web site  for this practice guideline and additional ones mentioned below).
   3. Have current Basic Life Support (BLS) certification. For pediatric sedation, have Pediatric Advanced Life Support (PALS) certification. For adult sedation, have Advanced Cardiac Life Support (ACLS) certification or have an individual with ACLS certification available with a response time of less than 5 minutes.
   4. Meet the credentialing requirements of the facility and have privileges to perform sedation

2. Health Professional Responsible for Monitoring the Patient

   A physician, nurse, nurse practitioner, registered radiology assistant, or other qualified individual, other than the practitioner performing the procedure, must be present to monitor the patient throughout procedures performed with sedation/analgesia. This individual may administer the medications used for sedation/analgesia and may assist with minor, interruptible tasks during the procedure.

   This professional should:

   1. Be a physician, nurse, or other licensed health care provider authorized by the facility, whose primary job is to monitor the patient
   2. Be appropriately privileged by the institution
   3. Have current certification in BLS
   4. Be knowledgeable in the use, side effects, and complications of the sedative agent(s) and reversal agents to be administered
   5. Be knowledgeable and experienced in monitoring vital signs, using pulse oximetry, and cardiac monitoring, including the recognition of cardiac dysrhythmias
   6. Meet the credentialing requirements of the facility

The monitoring, medicating, and care of the patient should be the primary focus of this professional. He or she must be someone other than the person who performs the procedure.

Patient Selection

Patients who are ASA class I or II qualify for sedation/analgesia (see Appendix A in the original guideline document). Patients who are ASA class III or IV may require additional consideration.

These guidelines specifically exclude the following:

1. Patients managed by the anesthesiology or critical care service
2. Patients on mechanical ventilation
3. Patients who are ASA class V. Such patients should not be sedated by nonanesthesiologists

Risk Factors

All patients referred for sedation should be appropriately screened by a physician, registered nurse, nurse practitioner, physician's assistant, or other appropriately trained individual for the presence of risk factors that may increase the likelihood of an adverse effect. If risk factors are present, consultation with an anesthesiologist may be considered.

Risk factors include, but are not limited to, congenital or acquired abnormalities of the airway, liver failure, lung disease, congestive heart failure, symptomatic brain stem dysfunction, apnea or hypotonia, history of adverse reaction to sedating medications, morbid obesity, and severe gastroesophageal reflux. Positive pressure ventilation, with or without endotracheal intubation, may be necessary if respiratory compromise develops during sedation/analgesia. This may be more difficult in patients with airway abnormality. Some airway abnormalities may increase the likelihood of airway obstruction during spontaneous ventilation (see Appendix B in the original guideline document).

Patient Evaluation and Management

Sedation should be performed in accordance with ASA guidelines, as described below.

Adult patients and legal guardians providing consent should be informed of and agree to the administration of sedation/analgesia before the procedure begins. Minor patients should be informed of the procedure, as appropriate. The requirement for written informed consent should follow facility policies and procedures and state and local laws and regulations.

For outpatients, a responsible adult should accompany the patient on discharge from the facility.

1. Patient Preparation before Sedation

   Hospital guidelines for preprocedure fasting should be followed. A suggested pediatric fasting protocol is given in Appendix C of the original guideline document.

2. Evaluation before Sedation
   1. Electrocardiogram tracings and relevant laboratory values, when appropriate, should be available for review.
   2. A focused history and physical examination should be performed and recorded. It should include the patient's previous experience with sedation/analgesia, current medical problems, current medications, drug allergies, and any significant comorbidities. A physician, nurse practitioner, or physician assistant should perform the presedation evaluation.
   3. Prior to initiating sedation, an assessment of recent oral intake, recent illness, pulmonary status (including upper airway), cardiac status, baseline vital signs, level of consciousness, pulse oximetry, and electrocardiogram (when applicable) should be performed and recorded.

3. Management during Sedation
   1. Intravenous access must be maintained.
   2. Homeothermia should be preserved.
   3. Patients should be protected from pressure-related and position-related injuries.
   4. All patients should be continuously monitored throughout the procedure by physiologic measurements that should be recorded (at least every 5 minutes). These measurements include, but are not limited to, level of consciousness, respiratory rate, pulse oximetry, blood pressure (as indicated), heart rate, and cardiac rhythm. The types of measurements taken should comply with facility policies.
   5. Supplemental oxygen with size-appropriate equipment should be immediately available and administered as needed.
   6. Suction should be immediately available.
   7. A defibrillator with back-up emergency power and emergency cart, including equipment for intubation and ventilation, should be immediately available.
   8. The route, dosage, and time of all sedation and reversal medications should be documented on the sedation record by the health professional responsible for monitoring the patient.
   9. Drug antagonists and intravenous fluids should be immediately available; their use should be based on the clinical circumstances.
   10. For pediatric patients, intravenous sedative/analgesic drugs should be given based on the patient's weight in incremental doses that are titrated to the desired endpoints of sedation and analgesia. Weight based dosing should operate within the maximum dose limit guidelines for each medication. For all patients, sufficient time must elapse between doses to allow the effect of each dose to be assessed before subsequent drug administration. When drugs are administered by nonintravenous routes (e.g., oral, rectal, intramuscular), allowance should be made for the time required for drug absorption before supplementation is considered.
   11. In adult patients, intravenous sedative/analgesic drugs are given in incremental doses that are titrated to the desired endpoints of sedation and analgesia.
   12. Combinations of sedative and analgesic agents should be administered as appropriate for the procedure being performed and the medical condition of the patient. Ideally, each component should be administered individually to achieve the desired effect (e.g., additional analgesic mediation to relieve pain, additional sedative medication to decrease awareness or anxiety). The combinations of sedative and analgesic agents may potentiate respiratory depression. This underscores the need to dose each agent appropriately, as well as the need to monitor respiratory function.

4. Recovery Following Sedation
   1. The patient must recover in an area where continuous monitoring and resuscitative equipment (e.g., suction, oxygen) are immediately available. Monitoring should include, but is not limited to, the level of consciousness, respiratory rate, pulse oximetry, blood pressure, and heart rate and rhythm, and should comply with facility requirements.
   2. Levels of consciousness and vital signs must be monitored at intervals consistent with recovery status until all return to levels acceptable for discharge. A patient may not leave the recovery area without accompanying monitoring personnel until vital signs and level of consciousness are at acceptable levels as determined by facility policy.
   3. If use of reversal agents was required, the level of consciousness and vital signs should return to acceptable levels for a period of 2 hours from the time of administration of the reversal agent before monitoring ends. (Use of reversal agents may be associated with relapse into a deeper level of sedation than intended after successful rescue, and repeated doses may be required.)
   4. The monitoring personnel will notify a supervising physician (who should remain available until recovery is complete) of any significant change in the patient's clinical status.
   5. Qualified monitoring personnel (as described above) must be immediately available to the patient from the initiation of sedation until the patient has adequately recovered or has been turned over to the appropriate personnel delivering recovery care.

Sedation-Related Documentation

Adequate documentation of all aspects of patient evaluation and monitoring is essential for high-quality patient care. This documentation should include, but is not limited to:

1. Dose, route, site, and time of administered drugs
2. Patient's response to medication and the procedure
3. Inspired concentrations of medical gases, such as oxygen and nitrous oxide, their rate and duration, and method of administration
4. Physiological data from monitoring
5. Any rescue interventions, including ventilatory support, or use of reversal medications, and the patient's response
6. Any untoward reactions and their resolution

Reporting should be in accordance with the "ACR–SIR Practice Guideline for the Reporting and Archiving of Interventional Radiology Procedures."

Discharge Criteria

1. The patient should not be discharged until vital signs, level of consciousness, and motor function have returned to the patient's preprocedure baseline or an acceptable level, as determined by the health care professional responsible for monitoring the patient and dependent on the patient's destination.
2. When discharge is to home, written discharge instructions will be given to the patient or accompanying responsible adult. The written discharge instructions should include, but not necessarily be limited to:
   1. Physician contact information, including after-hours contact information, in the event of postprocedure problems
   2. Advice against driving or operating dangerous machinery for a minimum of 12 hours
   3. Advice against alcohol intake for 24 hours
   4. Possible adverse effects of medications given and the need to seek medical attention in the event of an adverse effect

Equipment

See the original guideline document for information about equipment specifications.

None provided

The type of supporting evidence is not specifically stated for each recommendation.

Quality Control and Improvement, Safety, Infection Control, and Patient Education

Policies and procedures related to quality, patient education, infection control, and safety should be developed and implemented in accordance with the American College of Radiology (ACR) Policy on Quality Control and Improvement, Safety, Infection Control, and Patient Education appearing under the heading Position Statement on QC & Improvement, Safety, Infection Control, and Patient Education on the ACR Web site .

A record should be kept for all patients receiving sedation, indicating sedation failure and adverse effects (e.g., vomiting, hypoxic events, resuscitation, and 24-hour follow-up when possible) and possible explanations for adverse outcomes. Patient care areas using sedation and analgesia should have policies and procedures for reporting complications encountered during sedation and analgesia to the quality-assurance committee.

Not applicable: The guideline was not adapted from another source.

American College of Radiology

Guidelines and Standards Committee of the Commission on Interventional and Cardiovascular Radiology in collaboration with the Society of Interventional Radiology (SIR)

Collaborative Committee

American College of Radiology (ACR): Richard Towbin, MD (Chair); Christine P. Chao, MD; Drew Caplin, MD; Aradhana Venkatesan, MD

Society of Interventional Radiology (SIR): Sanjoy Kundu, MD; Michael Wallace, MD; Kevin Baskin, MD

ACR Guidelines and Standards Committee - Interventional: Donald L. Miller, MD, FACR (Chair); Stephen Balter, PhD, FACR; Drew M. Caplin, MD; Christine P. Chao, MD; John D. Grizzard, MD; John W. Ho, MD; Sanjoy Kundu, MD; Walter S. Lesley, MD, FACR; Philip M. Meyers, MD; Harjit Singh, MD; Timothy L. Swan, MD; Aradhana Mukherjea Venkatesan, MD; Anne C. Roberts, MD, FACR (Chair, Commission)

Comments Reconciliation Committee: Philip S. Cook, MD, FACR (Chair); Kimberly E. Applegate, MD, MS, FACR; Kevin M. Baskin, MD; Drew M. Caplin, MD; Christine P. Chao, MD; Howard B. Fleishon, MD, MMM, FACR; Alan D. Kaye, MD, FACR; Amy L. Kotsenas, MD; Sanjoy Kundu, MD; Paul A. Larson, MD, FACR; Lawrence A. Liebscher, MD, FACR; Donald L. Miller, MD, FACR; Anne C. Roberts, MD, FACR; Richard A. Szucs, MD, FACR; Richard B. Towbin, MD, FACR; Aradhana M. Venkatesan, MD; Michael J. Wallace, MD; E. Kent Yucel, MD, FACR

Not stated

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.

Print copies: Available from the American College of Radiology, 1891 Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

The following are available:

• The process of developing ACR practice guidelines and technical standards. Reston (VA): American College of Radiology. Electronic copies: Available from the American College of Radiology (ACR) Web site .
• Purpose and intended use. Reston (VA): American College of Radiology. Electronic copies: Available from the ACR Web site .

None available

This NGC summary was completed by ECRI Institute on November 4, 2011.

Copyright © by the American College of Radiology, 1891 Preston White Dr., Reston, VA 20191-4397, 703-648-8900. All rights reserved. No reproduction of this material in any format, electronic or otherwise, is permitted except with prior written consent from the American College of Radiology.