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Review of Propofol and Auxiliary Medications Used for Sedation

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Review of Propofol and Auxiliary Medications Used for Sedation SGA200132.qxp 7/26/10 8:43 AM Page 284 Marsha L. Ellett, PhD, RN Review of Propofol and Auxiliary Medications Used for Sedation ABSTRACT The sedative-hypnotic propofol (2,6-diisopropylphenol) is being increasingly used for sedation during painful diagnostic and therapeutic procedures in adults and children. The purpose of this article is to present a general overview of the use of propofol for endoscopic sedation. Advantages and disadvantages of using propofol for sedation, as well as its pharmacokinetics, preparation for use, dosing for endoscopic sedation, auxiliary sedative and analgesic medication options, methods of administering, adverse effects with interventions, recovery, and patient–physician satisfaction are discussed. Finally, next steps necessary to optimize future use of propofol are suggested. ropofol (2,6-diisopropylphenol, Diprivan; Pharmacokinetics AstraZeneca, Wilmington, DE), a rapid-acting Propofol pharmacokinetics involves a three-compart- sedative–hypnotic medication, was introduced ment model: plasma, rapidly equilibrating tissues, and clinically by Pecaro and Houting in 1985 slowly equilibrating tissues (Schnider et al., 1998). P(Pecaro & Houting, 1985) and approved by the U.S. Propofol is 98% plasma-protein bound (American Food and Drug Administration (FDA) in 1989 for the Society for Gastrointestinal Endoscopy [ASGE], 2004). induction and maintenance of general anesthesia and The rapid onset of anesthesia and sedation, approxi- sedation in ventilated patients. In addition to its seda- mately 40 seconds after an intravenous induction dose, is tive and hypnotic properties, propofol provides amne- due to the rapid equilibration between plasma and the sia but minimal levels of analgesia. As case reports of highly perfused tissue of the brain (Schnider et al., 1998). propofol infusion syndrome (PRIS) surfaced (discussed Peak effect is 1-2 minutes, and duration of effect is 4- later under serious adverse effects), a serious adverse 8 minutes (SedationFacts.org, 2010). Propofol decreases effect warning against the long-term use of propofol in cerebral metabolism specifically in the frontal, parietal, pediatric patients was issued (American Academy of and occipital lobes and hippocampus that involve areas Pediatrics Committee on Drugs, 1992). This led to a belonging to the sensory (auditory, visual, and voluntary change in the package insert provided by somatosensory), motor, and limbic systems (Kikuchi, AstraZeneca. At first, the FDA chose not to issue a Wang, Sato, & Okumara, 1998; Sanna et al., 1999). It warning, citing that its review of the data failed to find exerts its effect by modulating the inhibitory function of a link between propofol infusion and deaths in chil- the main neurotransmitter ␥-aminobutyric acid (GABA) dren (FDA, 1992); however, in 2001, the FDA did mainly through GABAA receptors (Trapani, Altomare, issue a recommendation that propofol not be used for Sanna, Biggio, & Liso, 2000). GABAA receptors are pediatric sedation. The FDA has not changed its rec- ligand-gated ion channels coupled to an integral chloride ommendation in the interim. channel (Sieghart, 1995). Propofol has no direct effect on either the sinoatrial Received July 31, 2009; accepted November 29, 2009. or atrioventricular (AV) node conductivity of the heart; however, it does decrease heart contractility and after- About the author: Marsha L. Ellett, PhD, RN, is Professor, Indiana University School of Nursing, Indianapolis. load reduction leading to hypotension (Romano et al., Correspondence to: Marsha L. Ellett, PhD, RN, Indiana University 1994). A decrease in cerebral blood flow by up to 50%, School of Nursing, 1111 Middle Drive, Room 439, Indianapolis, IN with a simultaneous decrease in intracranial pressure, 46202 (e-mail: [email protected]). has been seen following propofol use (Marinella, DOI:10.1097/SGA.0b013e3181eac371 1997). 284 Gastroenterology Nursing Copyright © 2010 Society of Gastroenterology Nurses and Associates. Unauthorized reproduction of this article is prohibited SGA200132.qxp 7/26/10 8:43 AM Page 285 Review of Propofol and Auxiliary Medications Used for Sedation Propofol has dose-dependent, radical-scavenging or should not used if there is evidence of sedimentation activities similar to the endogenous antioxidant vitamin or discoloration (Leffler, 2004). Propofol is incompatible E (Vanlersberghe & Camu, 2008). It also demonstrates with polyvinyl chloride infusion tubing. Compatible anti-inflammatory properties and mild bronchodilating intravenous solutions include: Ringer’s lactate solution capabilities and has been shown to be useful in the (RL), 5% dextrose (D5), D5/RL, D5/0.45 sodium chlo- management of refractory seizures and severe delirium ride (NS), and D5/0.25NS (AstraZeneca, 2001; Levadouz, tremens (Marik, 2004). Propofol does not trigger Sautou, Bazin, Schoeffler, & Chopineau, 1996; Sautou- malignant hypothermia (Fruen, Mickelson, Roghair, Miranda, Levadoux, Groueix, & Chopineau, 1996). Litterer, & Louis, 1995). Depending on the manufacturer, ethylenediaminete- Because the half-life of propofol is very short, recov- traacetic acid (Diprivan) or sodium metabisulfite (generic ery from sedation with propofol is quick and smooth propofol) are added to retard microbial growth (Kang, with little nausea and vomiting (Bryson, Fulton, & 2002; Marik, 2004). In spite of these additives, propofol Faulds, 1995). Propofol is metabolized in the liver by supports bacterial growth from extrinsic contamination the cytochrome P450 system into four inactive once the ampule or vial is accessed. Because even small metabolites, 1-quinol glucuronide, 4-quinol glu- numbers of organisms may result in clinical infections, curonide, propofol glucuronide, and 4-quinol sulfate, strict aseptic techniques, including disinfecting appropri- and eliminated in the urine (Bryson et al., 1995; Cillo, ately the neck of ampules or the rubber stopper of vials 1999; Schnider et al., 1998; Trapani et al., 2000; before use, using careful technique when preparing a Vanlersberghe & Camu, 2008). syringe of the medication immediately before use, The pharmacokinetic parameters of propofol are restricting the use of an ampule or vial to a single patient, altered by factors including weight (SedationFacts.org, and discarding any unused medication after 6 hours, are 2010). A prolonged effect may be observed in patients essential during the handling of propofol to prevent extrin- with high proportions of adipose tissue compared with sic contamination and dangerous infectious complications overall body weight (Steinbacher, 2001). The presence (Bryson et al., 1995). of cirrhosis or renal dysfunction does not significantly alter the pharmacokinetics of propofol (Bryson et al., Recommendations of 1995; Weston et al., 2003). Professional Organizations Propofol rapidly crosses the placenta and may lead According to the American Society of Anesthesiologists to neonatal depression (Bryson et al., 1995; Rex, (ASA, 2006), all deep sedation should be provided by Overley, & Walker, 2003). It has reportedly been trained anesthesia providers. On the other hand, the found in human milk, but the effects of small amounts American Gastroenterological Association, the of propofol on infants are not known; therefore, American College of Gastroenterology, and the ASGE propofol should be used during pregnancy and lacta- issued a joint statement that propofol can safely be tion only if clearly needed (SedationFacts.org, 2010). administered by specially trained nurses under the supervision of an endoscopist. Preparation for Use Propofol is lipophilic (i.e., fat soluble) and is prepared The Society of Gastroenterology Nurses and as an oil–water emulsion consisting of 1% propofol, Associates, Inc. support the position that regis- 10% soybean oil, 2.25% glycerol, and 1.2% egg lecithin tered nurses trained and experienced in gastroen- (ASGE, 2004). It is available in 20-, 50-, or 100-mL terology nursing and endoscopy can administer vials containing 10 mL/mg propofol (SedationFacts.org, and maintain moderate sedation and analgesia 2010). The patent for Diprivan expired in 1999 (Kang, by the order of a physician. In addition, the 2002). In collaboration with Baxter Healthcare gastroenterology registered nurse can be given Corporation (Deerfield, IL), Gensia-Sicor received the responsibility for the administration of reversal FDA approval for generic propofol the same year. agents prescribed by the physician. (2008, Although propofol can cause allergic reactions, it is p. 250) generally safe from anaphylactic reactions because it does not promote the release of histamine from mast Currently, state boards of nursing in 30 states allow cells (Stellato et al., 1991). Patients who are allergic to registered nurses to administer moderate (conscious) eggs, soy products, or sulfites as well as those having sedation under the direct supervision of a physician known mitochondrial or lipid metabolism disorders (SedationFacts.org, 2010). should not receive propofol (Marik, 2004). Because propofol is a lipid-based medication, neither Dosing for Endoscopic Sedation refrigeration nor freezing are recommended. It must be According to SedationFacts.org (2010), ASA Classes I shaken well prior to use and should be uniformly white (healthy) and II (limited disease) adults younger than VOLUME 33 | NUMBER 4 | JULY/AUGUST 2010 285 Copyright © 2010 Society of Gastroenterology Nurses and Associates. Unauthorized reproduction of this article is prohibited SGA200132.qxp 7/26/10 8:43 AM
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