© 2008 The Medical-Legal News
By Frances W. Sills, RN, MSN, ARNP
Prior to the 1840s anesthesia was not used when individuals underwent operations. The use of alcohol, opium or other botanicals sometimes helped to alleviate the agony, but most patients remained conscious and endured excruciating pain. The introduction of ether in 1846 allowed surgeons to perform internal procedures that would have been too painful or complicated to perform on a conscious patient.
For many decades after anesthetics became a routine part of surgery, practically nothing was known about how they worked. Virtually all scientists believed that anesthetics blocked nerve cell signaling by disrupting fatty molecules in the membranes that envelop cells. Scientists have now learned that general anesthesia consists of several components, including sedation, unconsciousness, immobility, analgesia (lack of pain) and amnesia (lack of memory). They have developed agents that can provide each of these elements separately, which enables anesthesiologists to tailor the regimen to each procedure and patient.
Each year millions of individuals undergo surgery safely with general anesthesia, although there always remains some risk. Many of these procedures, which have improved the health, longevity and quality of life of the population would not have been possible without modern anesthetic techniques. The discovery that local and regional anesthetics can be used to block specific nerves has provided the patient and physicians with an alternative to general anesthesia for many procedures. The most recent of the discoveries is the use of what has been called “conscious sedation” to facilitate procedures such as:
• Breast biopsy,
• Minor foot surgery,
• Minor bone fracture repair,
• Plastic or reconstructive surgery,
• Endoscopy and other diagnostic procedures.
The debate regarding conscious sedation — now being referred to as moderate sedation — has been going on for years. It has become increasingly popular for both hospitals and outpatient procedures. With its wider use comes a number of new responsibilities for nurses who care for patients undergoing moderate sedation and analgesia. As the use of conscious sedation continues to grow, it is important that nurses have the understanding and knowledge of just what conscious sedation means, where its use is increasing and what responsibilities the professional nurse has when administering the various agents that provide conscious sedation. Four physiological states exist in which the patient receiving anesthesia can be. They are:
A. Conscious sedation or moderate sedation is a state in which the patient can respond purposefully to verbal commands (alone or accompanied by light tactile stimulation), maintain a patent airway and maintain breathing on his own.
B. Minimal sedation (also called anxiolysis) is a lighter state of sedation in which the patient can respond normally to verbal commands.
C. Deep sedation or analgesia is a state in which the patient may need help maintaining a patent airway and may need assisted ventilation. He cannot be easily aroused, but does respond purposefully to repeated or painful stimulation.
D. General anesthesia is a state in which the patient is not arousable, even to painful stimulation, needs assistance in maintaining a patent airway and may require positive-pressure ventilation.
The nurse who is administering moderate sedation must be knowledgeable of the drugs that are used. This knowledge includes, but is not limited to, effects of the medication, potential side effects, contraindications for administration of the medicine and the amount of the medication to be administered. The requisite skills include the ability to: 1) competently and safely administer the medication by the specified route; 2) anticipate and recognize potential complications of the medication and 3) recognize emergency situations and institute emergency procedures. The nurse would also ensure that all safety measures are in force, including back-up personnel skilled and trained in airway management, resuscitation and emergency intubation should complications occur. The nurse managing the care of patients receiving conscious sedation should not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse.
These drugs must be administered in small doses and the patient’s response assessed before giving another dose. Body mass and other factors affect a patient’s reaction. [See chart, next page, bottom, for the most common drugs used.]
In recent years, Propofol, one of the intravenous sedative hypnotics, has been gaining popularity over midazolam and fentanyl as the drug of choice for moderate sedation and analgesia. The use of this drug during endoscopic, radiologic and other procedures is growing in hospitals, ambulatory surgical procedures and physician offices because it offers certain advantages over other drugs used for sedation when used by trained and credential practitioners because it:
• Has a rapid onset and a short duration of action,
• Allows patients to wake up, recover and return to baseline activities and diet sooner that some other sedation agents,
• Reduces the need for opioids, resulting in less nausea and vomiting.
Propofol has also replaced thiopental sodium as a rapid-acting nonbarbiturate induction and maintenance agent for anesthesia or sedation during major surgery. This has added more fuel to the controversy of who should be administering drugs that provide varying levels of sedation.
What are the necessary credentials for administering Propofol? Healthcare facilities, professional organizations and licensing boards across the country are asking this question. A difference of opinion continues among the professional societies about the necessary credentials for individuals administering Propofol for sedation. In brief, the American Society of Anesthesiologists (ASA), the American Association of Nurse Anesthetists and the American Association for Accreditation of Ambulatory Surgery Facilities believe that safe administration of Propofol to non-ventilator-assisted patients is limited to individuals trained in the administration of general anesthesia who are not simultaneously involved in the procedure. The ASA also suggests that, if this is not possible, non-anesthesia staff who administer Propofol must be qualified to rescue patients whose level of sedation becomes deeper than intended and who enter, if briefly, a state of general anesthesia.
In contrast, the American College of Gastroenterology, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society of Gastroenterology Nurses and Associates endorse nurse-administered Propofol under the direction of a physician if state regulations allow it, if the nurse is trained in the use of drugs causing deep sedation and if the nurse is capable of rescuing patients from general anesthesia or severe respiratory depression.
The Joint Commission on Accreditation of Healthcare Facilities (JCAHO) Standard PC.13.20 requires, for the administration of moderate or deep sedation, that a sufficient number of staff, in addition to the person performing the procedure, be present to perform the procedure and monitor and recover the patient. The person administering the sedative agent must be qualified to manage the patient at whatever level of sedation or anesthesia is achieved, whether intentionally or not. While there may be a need for additional monitoring personnel for the procedure, the person administering the sedation must be qualified to monitor the patient.
A review of various states’ Nurse Practice Acts finds that there are more than a dozen states that specifically consider nurse-administered Propofol beyond the scope of nursing practice. Others either do not address it or do in such general terms that it is one of those “gray” areas that need further clarification.
In 1991 a position paper developed by American Nurses Association representatives and several of the major specialty nursing organizations was endorsed by the ANA board of directors. This position paper was titled “Role of the Registered Nurse in the Management of Patients Receiving IV Conscious Sedation.” A statement within it reads: “It is within the scope of practice of the registered nurse to manage the care of patients’ IV conscious sedation during therapeutic, diagnostic or surgical procedures provided the following criteria are met:
1) Administration of IV conscious sedation medications by the non-anesthetist nurse is allowed by state law and institutional policy, and protocol;
2) A qualified anesthesia provider or attending physician orders the medications to achieve the IV conscious state;
3) Guidelines for patient monitoring, dug administration and protocols for dealing with potential complications or emergency situations are available and have been developed in accordance with accepted standards of anesthesia practice;
4) The registered nurse managing the care of the patient receiving IV conscious sedation shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring;
5) The registered nurse managing the care of patients receiving IV conscious sedation is able to:
a. Demonstrate the acquired knowledge of anatomy, physiology, pharmacology, cardiac arrhythmia recognition and complications related to IV conscious sedation and medications;
b. Assess total patient care requirements during IV conscious sedation and recovery. Physiologic measurements should include, but not be limited to, respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm and the patient’s level of consciousness;
c. Understand the principles of oxygen delivery, respiratory physiology, transport and uptake and demonstrate ability to use the oxygen delivery devices;
d. Anticipate and recognize potential complications of IV conscious sedation in relation to the type of medication being administered;
e. Possess the requisite knowledge and skills to assess, diagnosis and intervene in the event of complications with orders (including standing orders) or institutional protocols or guidelines;
f. Demonstrate skill in airway management resuscitation;
g. Demonstrate knowledge of the legal ramifications of administering IV conscious sedation and/or monitoring of patients receiving conscious sedation, including the RN’s responsibility and liability in the event of an untoward reaction or life-threatening complication;
6) The institution or practice setting has in place an educational or competency validation mechanism that includes a process for evaluation and documentation of the individual’s demonstration of the knowledge, skills and abilities related to the management of patients receiving IV conscious sedation. Evaluation and documentation of competence occurs on a periodic basis according to institutional policy.”
The full context of the position paper with additional guidelines can be found on the ANA website at www.nursingworld.org.
It is interesting to note that the ANA and the nursing specialty organizations addressed this issue as early as 1991 and still the debate rages.
Presently there are a multitude of situations where nurses are administering drugs for moderate sedation. This being the reality, it is important for nurses to know that Propofol is considered a high-alert drug. The dosing and titration of this drug is variable, as it is based on the patient’s response and tolerance to the drug. Profound changes in respiratory status can occur rapidly. A patient can go from breathing normally to a full respiratory arrest in seconds, even with low doses, without warning from typical assessment parameters. A pre-op assessment must determine a thorough history of the patient’s allergies (patients who are allergic to eggs or soybeans should not receive Propofol), and any medical problems with special attention to respiratory and cardiac problems, tobacco, alcohol or drug use. Any previous adverse effects with sedation or analgesia cannot be overemphasized.
When the patient arrives in the procedure area, baseline vital signs and oxygen saturation on room air using pulse oximetry should be obtained. The blood pressure, heart rate and rhythm, respiratory rate and oxygen saturation should be recorded every five minutes during moderate sedation. Drugs used in moderate sedation and analgesia are titrated to keep the patient at 2 to 3 on the Ramsay sedation scoring system:
1) Patient is anxious, restless, agitated, or all three.
2) Patient is cooperative, oriented and tranquil.
3) Patient is easily arousable and responds appropriately to stimuli.
4) Patient is asleep but has brisk responses to a glabellar tap or an auditory stimulus.
5) Patient is asleep and has sluggish responses to a glabellar tap or auditory stimulus; responds to painful stimuli.
6) Patient does not respond to stimuli.
During moderate sedation and analgesia, if a patient develops respiratory depression or is difficult to wake, protect his airway. If the patient was sedated with benzodiazepine, give flumazenil as an antidote. If he was sedated with an opioid, give naloxone.
Because flumazenil is a benzodiazepine receptor antagonist, it should be used cautiously in patients who use benzodiazepines chronically or who have a history of epilepsy, as flumazenil can cause seizures in these patients. In opioids-tolerant patients, the opioids-antagonist naloxone can cause tachycardia, hypertension, agitation, nausea, vomiting, diaphoresis, seizures and pulmonary edema if given too quickly or in too large a dose. Monitor the patient closely for opioid-related respiratory depression, which can occur if the opioid’s duration of action is longer than that of naloxone.
With the increasing use of conscious or moderate sedation, and particularly the medication Propofol, it becomes increasingly important that nurses be knowledgeable about just what conscious or moderate sedation is, the nurse’s role in administering it, the state’s Nurse Practice Act’s position as it relates to the scope of practice, and a given institution’s policies. With this knowledge each nurse can make an informed decision as to whether he or she wants to assume this new and fast-growing additional responsibility.
The jury is still out on whether or not this role should be considered advanced practice or not. It is important that when and if a decision is made, everyone involved will have a clear understanding of the ramifications, and that mechanisms will be put in place to ensure optimum safety for the patient. •
Frances W. (Billie) Sills, RN, MSN, ARNP, is an assistant professor at ETSU College of Nursing in Tennessee;firstname.lastname@example.org
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