(Dec. 3, 2009) - The worldwide safety experience of endoscopist-administered propofol sedation now exceeds 600,000 patients. The low rate of serious adverse events underscores the safety of nonanesthesiologist-administered propofol (NAAP) for gastrointestinal (GI) procedures, provided that it is administered by a team of individuals who have received training specific to the administration of propofol according to the "Position statement: nonanesthesiologist administration of propofol for GI endoscopy" issued by the four major gastroenterology and hepatology societies.
"Based on the evidence, the administration by nonanesthesiologists of propofol versus sedation with commonly used agents is comparable with respect to their efficacy and safety profiles. Gastroenterologists and registered nurses in many countries have successfully acquired the skills necessary to safely administer propofol-based sedation. Proper training and patient selection are crucial for the safe practice of nonanesthesiologist-administered propofol sedation," said Lawrence B. Cohen, MD, chair of the Sedation Task Force. "Although there are no cost-effectiveness data comparing NAAP to anesthesiologist-administered propofol sedation for GI endoscopy, it is known that the use of anesthesiologist-administered sedation for healthy, low-risk patients undergoing routine GI endoscopy results in higher costs with no proven benefit with respect to patient safety or procedural efficacy."
Propofol is an ultra-short-acting sedative agent with no analgesic properties, which, at subhypnotic doses, provides sedative and amnestic effects. Approved by the Food and Drug Administration for the induction and maintenance of anesthesia, propofol's product label indicates that it ''should be administered only by persons trained in the administration of general anesthesia.'' Since its introduction in the 1980s, however, its clinical applications have expanded to include procedural sedation, such as for endoscopy.
The statement is issued jointly by the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA) Institute and the American Society for Gastrointestinal Endoscopy (ASGE). A four-member committee composed of a representative from each society was convened to develop a document designed to provide an evidence-based assessment of propofol-mediated sedation by properly trained gastroenterologists and other nonanesthesiologists. The document was reviewed and approved by the governing boards of all four societies and is being published in the December issues of Hepatology, the American Journal of Gastroenterology, Gastroenterology and GIE: Gastrointestinal Endoscopy.
A number of recommendations are made in the statement regarding NAAP for GI endoscopy:
Safety of NAAP equivalent to "standard" sedation: The safety profile of NAAP is equivalent to that of "standard" sedation with commonly used agents such as a narcotic and a benzodiazepine with respect to the risks of hypoxemia, hypotension, and bradycardia for upper endoscopy and colonoscopy. The safety profile of NAAP when it is administered during endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) appears to be equivalent to that of standard sedation. The worldwide experience with NAAP during these procedures (EUS and ERCP), however, is insufficient to draw definitive conclusions about its use in these settings.
Efficacy of NAAP for GI endoscopy: For upper endoscopy, colonoscopy, ERCP, and EUS, the time for sedation induction is shorter with NAAP than with sedation with commonly used agents. Recovery time for upper endoscopy, colonoscopy, ERCP, and EUS when using NAAP is shorter than for sedation with a narcotic and a benzodiazepine. Patient satisfaction with NAAP is equivalent or slightly superior to that with standard sedation.
Economics of NAAP for GI endoscopy: For ERCP and EUS, NAAP is more cost-effective than standard sedation. Nonanesthesiologist-administered propofol sedation improves practice efficiency when compared to sedation with commonly used agents. The use of anesthesiologist-administered sedation for healthy, low-risk patients undergoing routine GI endoscopy results in higher costs with no proven benefit with respect to patient safety or procedural efficacy.
Training guidelines for NAAP for GI endoscopy:
- NAAP requires the acquisition of skills and abilities that are distinct and apart from those necessary for standard sedation. Training programs should provide both didactic and practical, hands-on learning experiences.
- Individuals administering propofol should be proficient in the management of upper and lower airway complications, including manual techniques for re-establishing airway patency, use of oral and nasal airway devices, and proper bag-mask ventilation. Basic life support or advanced cardiac life support certification is required. Training with life-size manikins and/or human simulators improves the acquisition of these skills.
- Preceptorship (practical experience and training that is supervised by an expert such as an anesthesiologist or qualified endoscopist) is an important element of training for physicians and nursing personnel acquiring the skills to administer propofol.
- Capnography (a monitoring device that measures the concentration of carbon dioxide in exhaled air and displays a numerical readout and waveform tracing) reduces the occurrence of apnea and hypoxemia during ERCP/EUS and upper endoscopy/colonoscopy.
Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. Millions of endoscopies are performed in the U.S. each year. It is a safe, effective and well-tolerated procedure. Sedation is commonly used to make the patient comfortable throughout the exam.
About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org.
About the American Association for the Study of Liver Diseases
AASLD is the leading medical society focused solely on advancing the science and practice of hepatology and represents more than 3,300 practitioners, researchers, and allied health professionals worldwide. Founded by physicians in 1950, AASLD has upheld the standards of the profession and fostered research that generates treatment options for the millions of patients with liver diseases. www.aasld.org.
About the American College of Gastroenterology
Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 11,000 individuals from 80 countries. The College is committed to serving the clinically oriented digestive disease specialist through its emphasis on scholarly practice, teaching and research. The mission of the College is to serve the evolving needs of physicians in the delivery of high quality, scientifically sound, humanistic, ethical, and cost-effective health care to gastroenterology patients. For more information, visit www.acg.gi.org.
About the American Society for Gastrointestinal Endoscopy
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 11,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asge.org and www.screen4coloncancer.org for more information and to find a qualified doctor in your area.