Medical News USA / Canada: Conscious Sedation Consulting announces the development of a course to educate non-anesthesia physicians and nurses in the administration of propofol. The company announced that a comprehensive didactic course will be provided nationally for physicians, staff and organizations which wish to add propofol administration to their choice of sedatives. The course covers patient selection, a comprehensive detailed explanation of the pharmacology and pharmacokinetics of propofol, BIS monitoring, computer-controlled infusions, airway management, physiological monitoring, as well as the prevention, recognition and management of adverse events. Also covered are documentation, accreditation standards, patient recovery, discharge, follow up and process improvement. The seminar uses as a foundation, an understanding of a culture of safety as described by the Institute of Medicine in its report To Err is Human.
Propofol (2,6-diisopropyl phenol) is classified as an ultra-short-acting hypnotic agent that provides sedative, amnesic, and hypnotic effects. Propofol rapidly crosses the blood-brain barrier and causes a depression in consciousness that is likely related to potentiation of the g-aminobutyric acid A receptor in the brain.1 Propofol is 98% plasma-protein bound, and it is metabolized primarily in the liver by conjugation to its glucuronide and sulfate to produce water-soluble compounds that are excreted by the kidney. Typically, the time from injection to the onset of sedation is 30 to 60 seconds. Its duration of effect is 4 to 8 minutes. The pharmacokinetic properties do not significantly change in patients with renal failure or moderately severe chronic liver disease. Dose reduction is required in patients with cardiac dysfunction and in the elderly as a result of decreased clearance of the drug. Propofol potentiates the central nervous system effects of analgesics and sedatives such as benzodiazepines, barbiturates, narcotics, and other hypnotic/sedative agents. Therefore, the dose requirements of these agents may be reduced. The cardiovascular effects of propofol include decreases in cardiac output, systemic vascular resistance, and arterial pressure.2 Negative cardiac inotropy and respiratory depression can be seen with the use of propofol. These effects reverse rapidly with dose reduction or interruption of drug infusion3 and rarely require temporary ventilator support.
Controversy surrounds the use of Propofol by non-anesthesia providers. This is in part due to the FDA approved package insert which states that propofol should be administered by individuals trained in the administration of general anesthesia. Additionally some independent practitioners are either unwilling or unable to administer propofol due to local institutional policies or in some cases state regulatory restrictions. In spite of such concerns propofol use has seen a dramatic increase over the last decade. A 2006 study published by the American Journal of Gastroenterolgy reported that 68% of US endoscopists using conventional sedation indicate that they would prefer to administer propofol but are reluctant to do so because of widespread perception of increased complication risks.4 Propofol is more widely used in other countries.
John Hexem, MD, PhD, board certified anesthesiologist and co-founder of Conscious Sedation Consulting, LLC, stated "When used judiciously by physicians with specific training in the administration of propofol, it is a very nice drug. It has very favorable pharmacokinetic properties and patients regain full consciousness quickly, alert and comfortable. I have been administering propofol since 1991 and think it has definite advantages." Dr. Hexem also cautions that "proper monitoring and training that includes advanced airway management skills should be acquired prior to using this drug. Providers using propofol also need a thorough understanding of the continuum of sedation as described by the American Society of Anesthesiologists and national accrediting and safety organizations".
Since 2002 more than 500,000 subjects have received propofol for endoscopic sedation.5
From this data, propofol in appropriate patients with trained personnel has demonstrated an excellent safety record. Transient hypoxia occurs in 3% to 7% of cases and transient hypotension in 4% to 7%. Time to recovery ranged between 14 and 18 minutes. In a retrospective review of Nurse Administered Propofol Sedation (NAPS) in several centers and involving greater than 36,000 endoscopies, the rate of clinical adverse events, defined as apnea or airway compromise that required assisted ventilation via bag-mask, ranged from 0.1% to 0.2%. 6 No patients required intubation, and none had permanent injury or death.
About: Conscious Sedation Consulting LLC, a patient safety advocacy firm that provides continuing education, training and consulting services to non anesthesia health care providers who offer sedation and analgesia services.
Statement of Disclosure: It is the policy of Conscious Sedation Consulting LLC, its principles and any of its employees to disclose any financial interest or other relationship with a commercial interest producing healthcare goods or services that has a direct bearing on the subject matter of any educational activity. A relevant financial interest or other relationship may include such things as grants or research support or a relationship such as an employee, consultant, major stockholder, member of speaker's bureau, and the like, that has been established for any dollar amount over the past 12 months. We have nothing to disclose.
1) Trapani G, Altomare C, Liso G, et al. Propofol in anesthesia: mechanism of action, structure-activity relationships, and drug delivery. Curr Med Chem 2007;7:249-71.
2) White PF. Propofol pharmacokinetics and pharmacodynamics. Semin Anesth 1988;7:4-20.
3) Short TG, Plummer JL, Chui PT. Hypnotic and anaesthetic interactions between midazolam, propofol and alfentanil. Br J Anaesth 1992;69: 162-7.
4) Cohen LB, Wecsler JS, Gaetano JN, et al. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol 2006;101:967-74.
5)Cohen LB, Hightower CD, Wood DA, et al. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc 2004;59: 795-803.
6) Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy. Gastroenterology 2005;129:1384-91.
Conscious Sedation Consulting announces its national educational event calendar for 2009.
This continuing educational event is for physicians, dentists, podiatrists, nurses and hygienists involved in the administration of enteral and parenteral conscious (moderate) sedation and analgesia services in the out-patient care setting.
This course has been developed in accordance with core principles described in National Accrediting Organization Standards and specialty society guidelines.
Course Topics Include
Culture of Safety
Standards
ASA Classification
Patient Assessment
Airway Management
Monitoring
Pharmacology
Adverse Events
Risk Management
Discharge & Follow-up
Process Improvement
All training and certification will be provided by a physicaian who has 25 years experience as a board certified anesthesiologist.
2009 Calendar
Jan. 31 - Kansas City MO 8:00 am - 4:00 pm Overland Park Marriott
Feb. 28 - Indianapolis IN 8:00 am - 4:00 pm Courtyard Indianapolis Carmel
Mar. 28 - Phoenix AZ 8:00 am - 4:00 pm The Mayo Courtyard
Apr. 25 - Richmond VA 8:00 am - 4:00 pm Venue to be announced
May 23 - Los Angeles CA 8:00 am - 4:00 pm Venue TBA
Jun. 20 - Chicago IL 8:00 am - 4:00 pm Venue TBA
Jul. 18 - Denver CO 8:00 am - 4:00 pm Venue TBA
Aug. 15 - Minneapolis MN 8:00 am - 4:00 pm Venue TBA
Sep. 26 - Seattle WA 8:00 am - 4:00 pm Venue TBA
Oct. 24 - Tampa Bay FL 8:00 am - 4:00 pm Venue TBA
Nov. 21 - San Francisco CA 8:00 am - 4:00 pm Venue TBA
Dec. 5 - Nashville TN 8:00 am - 4:00 pm Venue TBA
All times are local. Please register early - seating is limited.
Recently, my business partner and I were invited to speak at a nursing conference. He did his portion of the talk on sedation techniques and considerations. My portion was to focus on the legal aspects of nurse administered sedation and scope of practice issues. At the conclusion of our talk, about 12 nurses came up to me with concerns they were having, such as being asked to preform tasks in which they felt uncomfortable. The concerns ranged from being asked to administer propofol, to " our administrator wants us to disregard the n.p.o status so that we can squeeze in more cases". This reinforced my desire to help nurses in such situations. As a former nurse turned consultant, I receive many similar inquires vie e-mail and phone calls. Some cases are rather disturbing, I have spoken with several nurses that have resigned from their positions as a result of not being able to reach a resolution in similar situations. On one hand this appears unfortunate, on the other, I have to applaud the courage of those who stood and said "I will not do that". Now I am not a lawyer and I have never played one on T.V. so the following is simply for your consideration.
As registered nurses respond to the increased number of procedures that require sedation services and become more involved in the administration of these services, scope of practice issues arise. As a result many state boards of nursing have enacted formal policy statements that define and identify the responsibilities and requirements of the registered nurse involved in the administration of sedation services. It is the nurses responsibility to know what the policy is in his/her state, organization, department and job description. After reviewing many of these states requirements some common threads emerge. 1) That the nurse be able to demonstrate competence. 2) The nurse must have specialized education. If one can at least provide documentation to support these two items, negligence or malpractice is more difficult to prove, at least in most reasonable cases.
Here are a few suggestions for demonstrating competence and having specialized education;
Understanding the objectives and definitions of sedation
Understanding the continuum of sedation and analgesia
Understanding the ASA classification system
Knowing when to seek a consult
Maintaining ACLS certification
Receiving conscious sedation training, certification and credentials
Being current with state and organizational sedation policy
Understanding of best practice monitoring techniques
Becoming involved in a peer review and process improvement program
Being current with national and local nursing standards of accepted practices
Demonstrate continuing education specific to your field
Understanding of core principles established by national specialty societies involved in sedation and anesthesia
Fostering of communication between all members of the sedation team and others teams in your community
Join and be involved in specialty professional associations
Nurses have a duty to deliver safe nursing care to their patients. To that end, their standards of care include being cognizant of their "actions" for which nurses are liable. Through utilizing an ethical decision making process, appropriate training, experience and logical analysis on a case by case basis, nurses will be competent, confident, and as always, be acting in the best interests of the patient.
Conscious (or moderate) sedation has become an increasingly important subject in recent years. We have seen a vast increase in the number of procedures moving from traditional OR settings to ambulatory surgery centers and office-based practices over the last decade. As this trend continues, physicians and staff who have not administered sedation previously are looking to become informed on safe and efficient use of sedation in their patients.
Based on a review of state guidelines from several states we have prepared the following:
Every patient needs a free flowing intravenous line and supplemental oxygen administered via nasal cannula or face mask.
A health care provider other than the person performing the procedure should monitor the patient at all times. This is non-negotiable. That person should record in the medical record at minimum every five (5) minutes:
Level of consciousness (0 = unconscious, 1 = sedate but responsive, 2 = alert)
Peripheral oxygenation via pulse oximeter and respiratory rate
Heart rate, Heart rhythm, Blood Pressure
Pain score (0= none, 1= tolerable, 2= not tolerated)
This level of monitoring meets JCAHO guidelines. The provider monitoring the patient should be aware of known allergies, medical history, NPO status, and whether the patient may be difficult to intubate. Large men with bull necks and small mouths can be very difficult to ventilate and intubate. Such a person, or those with morbid obesity or other significant airway issues should be evaluated by an anesthesia provider.
Important history includes personal or family history of malignant hyperthermia, cardiac arrest, congestive heart failure, recent MI, stroke or TIA, heart rhythm disturbance, smoking, diabetes, COPD, or recent change in respiratory status. Is there recent onset of URTI or flu? A listing of current medications is important. It is recommended that patients be NPO for eight (8) hours before drug administration.
There should be suction capability and resuscitation equipment immediately available. Do not start until it is available. All providers should have ACLS certification. For almost all patients, a combination of two drugs, midazolam (Versed: 1 mg/cc) and fentanyl (Sublimaze: 50 ug/cc) can accomplish the goal of safely getting the patient through the procedure. Patients should be tolerating the procedure, and responsive to a command to open their eyes at all times. This state is called conscious sedation. The risk of administering any intravenous sedative or narcotic drug is loss of consciousness, inability to maintain the airway or apnea, desaturation and hypoxemia which if unrecognized and treated can proceed all the way to cardiac arrest. It can happen.
Midazolam treats anxiety. It has a specific anxiolytic action. The onset is 60-90 seconds. The duration of action for small doses is 10-15 minutes. Dose range for relatively healthy people is 1-5 mg total over 60 minutes. It is important to wait the 90 seconds to see what the effect of the first dose is before giving a second dose. Additional effects of midazolam are antegrade amnesia, and sedation. By itself, it rarely results in apnea when given in doses of 0.5 to 1 mg at a time. If the patient becomes disoriented- stop. Wait 15 minutes before resuming. Consider trying again later with an anesthesia provider.
Fentanyl treats pain. Onset of action is 90-120 seconds. Duration is also 10-1 minutes. Initial dose is 25-50 ug. Again it is important to wait to evaluate the effect of the first dose before administering a second dose. Dose range is 50-150 ug over 60 minutes. Effects of fentanyl are analgesia and respiratory depression. There may be a sedative effect, but there is rarely loss of consciousness. The patient may experience pruritus.
Each of these drugs by themselves are fairly predictable. However in combination, especially when administered simultaneously, there may be unpredictable loss of consciousness and or apnea. So do not administer both drugs simultaneously. Wait between doses. Patience is good. For a non-invasive procedure give a milligram of midazolam after monitoring is established, and before positioning the patient. For relatively healthy and robust patients a second milligram can be given safely.
If the patient still seems to be especially anxious, continue with midazolam. Wait between doses. Look for spontaneous eye closure, but with retained responsiveness to verbal commands. The simple phrase "Open your eyes" said gently should be able to establish responsiveness. Avoid the question "Are you OK?" It requires the patient to make an abstract evaluation of the situation. They think you are in charge. Ask what they sense or feel, and whether it is painful, tolerable or any other specific question. Warn them before inserting the examining finger or beginning the procedure. They probably won't remember anything, but they are supposed to be conscious and should be able to cooperate.
If the patient obviously experiences pain, then add fentanyl. Once you start using the fentanyl do not give any more midalozam unless you can really justify it to yourself. Start with half a cc (25 ug). Wait. Resume the procedure. If not tolerated repeat the dose. Wait. If you need more than 100-150 ug of fentanyl reexamine the situation. Fentanyl as the sole drug works nicely in patients who have previous experience with medical procedures, or otherwise seem to have good coping mechanisms. The dose range can be 150-300 ug over 60 minutes in divided doses. In the event the patient's respiratory rate slow to 6 breaths per minute, they may still be able to maintain adequate oxygenation. Occasionally you may have to encourage them to breathe. At these doses apnea unresponsive to stimulation is unusual unless there has been prior administration of midazolam. Meperidine (Demerol) in doses of 25-50 mg to a maximum of 200 mg is another good agent used by itself. It increases recovery time.
Another technique involves the use of a constant infusion of propofol. Propofol is a very short acting anesthetic which has been used frequently for GI procedures. Repeated use of this drug has the potential to render the patient unconscious, and thus it has been employed primarily by specilized anesthesia providers. Emergency Department physicians and gastroenterologists with appropriate training have successfully administered propofol for procedures in those arenas. It is used as a constant infusion to avoid fluctuating levels of sedation and responsiveness associated with intermittent bolus administration. Usually a base pre-medication with 1-2 mg of midazolam given IV over 5 minutes is followed by 2-3 ccs of propofol as an IV bolus followed by an infusion of 25-75 ug/kg/min. This regimen rarely results in apnea, but upper airway obstruction is a real possibility if the patient becomes deeply sedated. A jaw thrust usually suffices to relieve the obstruction. Supplemental oxygen administration is obviously crucial, as is constant awareness of the status of the patient.
Regardless of the pharmaceutical regimen, if the patient loses consciousness, but continues to ventilate and maintain oxygenation, then nothing needs to be done other than continued evaluation. Avoid further drug administration. If heavy snoring or desaturation occurs, then a simple jaw thrust is usually adequate. Unresponsiveness with cessation of spontaneous ventilation should be treated with mask ventilation. Hopefully intubation will never be required, but the capacity to do so should always be available. This is why all providers should have ACLS Certification.
You can get a feel for how the patient will respond to the drugs by carefully watching the response to the first dose. Patients taking narcotics or benzodiazepines chronically may require doubling of the corresponding doses. The art of it all involves balancing the dose to the level of stimulation associated with the procedure, with a common sense evaluation of how the patient is responding to the situation. Remember that if higher doses have been necessary to get the patient through the procedure, he may become unconscious or apneic once the stimulation ceases.
It may take 20-50 patients to gain some confidence with the regimen. Patients should not drive themselves home. If nausea occurs it can be treated with Zofran, 4 mg, though it usually resolves spontaneously within 2-3 hours.
For additional information or comments, call Conscious Sedation Consulting 888-581-4448
Our consulting firm and Web-site make every effort to provide accurate and up-to-date information, which is in accord with accepted standards and guidelines. Under no circumstances should any advice or information we may provide be considered the practice of medicine in Missouri or any other State. Diagnosis and treatment recommendations can only be made by a licensed independent practitioner in accordance with any laws or regulations in the state or states in which they may practice. The Partners of Conscious Sedation Consulting make no warranties that any information contained on their web site or which they may offer is totally free from error. This is the case especially because clinical standards are constantly changing through research and regulation. Conscious Sedation Consulting therefore disclaims all liability for direct or consequential damages resulting from the use of material presented on the web-site, in seminars or presentations, or in written or spoken responses to questions or requests. The proper dose for any medication cannot be predicted in advance. For sedative drugs, it is influenced by 1) the type, location, and duration of the procedure being performed in which sedation is being administered. 2) the age, sex, and family history of the person receiving the drug, 3) the acute or chronic administration of any other pharmaceuticals, herbal medicines, other treatment modalities, or other substances such as tobacco, alcohol, narcotics, and any and all other legal and illicit drugs 4) any concomitant medical, or psychological diseases for which the person may or may not be receiving treatment 5) the physiological state of the person including temperature, oxygenation, and function of all organ systems, and 6) the particular circumstances of any clinical or treatment situation. The administration of sedative medications is an art as in any form of healing art.
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