Propofol use during gastrointestinal endoscopy
2001; Elsevier BV; Volume: 53; Issue: 7 Linguagem: Inglês
10.1016/s0016-5107(01)70311-2
ISSN1097-6779
AutoresDouglas B. Nelson, Alan Barkun, Kevin P. Block, J. Steven Burdick, Gregory G. Ginsberg, David A. Greenwald, Peter B. Kelsey, Naomi L. Nakao, Adam Slivka, Paulette Smith, Nimish Vakil,
Tópico(s)Anesthesia and Sedative Agents
ResumoTechnology status evaluation report November, 2000IntroductionIn order to promote the appropriate use of new or emerging endoscopic technologies, the ASGE Technology Committee has developed a series of status evaluation papers. By this process relevant information about these technologies may be presented to practicing physicians for the education and care of their patients. In many cases, data from randomized controlled trials is lacking and only preliminary clinical studies are available. Practitioners should continue to monitor the medical literature for subsequent data about the efficacy, safety and socioeconomic aspects of the technologies.BackgroundPropofol, or 2-6 diisopropylphenol (AstraZeneca, Wilmington, DL; Baxter Pharmaceutical Products, Inc., New Providence, NJ) is an ultrashort acting sedative hypnotic agent that has received increased attention for use during endoscopy.1Bell GD. Premedication, preparation, and surveillance.Endoscopy. 2000; 32: 92-100Crossref PubMed Scopus (44) Google Scholar, 2Koshy G Nair S Norkus EP Hertan HI Pitchumoni CS. Propofol versus midazolam and meperdine for conscious sedation in GI endoscopy.Am J Gastroenterol. 2000; 95: 1476-1479Crossref PubMed Google Scholar, 3Carlsson U Grattidge P. Sedation for upper gastrointestinal endoscopy: a comparative study of propofol and midazolam.Endoscopy. 1995; 27: 240-243Crossref PubMed Scopus (158) Google Scholar, 4Roseveare C Seavell C Patel P Criswell J Kimble J Jones C et al.Patient-controlled sedation and analgesia, using propofol and alfentanil, during colonoscopy: a prospective randomized controlled trial.Endoscopy. 1998; 30: 768-773Crossref PubMed Scopus (76) Google Scholar, 5Reimann FM Samson U Derad I Fuchs M Schiefer B Stange EF. Synergistic sedation with low-dose midazolam and propofol for colonoscopies.Endoscopy. 2000; 32: 239-244Crossref PubMed Scopus (101) Google Scholar, 6Jung M Hofmann C Kiesslich R Brakertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam.Endoscopy. 2000; 32: 233-238Crossref PubMed Scopus (155) Google Scholar, 7Wehrmann T Kokabpick S Lembcke B Caspary WF Seifert H. Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study.Gastrointest Endosc. 1999; 49: 677-683Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar The distinctive sedative properties, pharmacokinetics, and pharmacodynamics form the basis of this report.Pharmacologic propertiesPropofol is an alkyl phenol derivative that possesses sedative, amnestic, and hypnotic properties but provides minimal analgesia.8Smith I White PF Nathanson M Gouldson R. Propofol: an update on its clinical use.Anesthesiology. 1994; 81: 1005-1043Crossref PubMed Scopus (569) Google Scholar, 9Marinella JA. Propofol for sedation in the intensive care unit: essentials for the clinician.Respiratory Medicine. 1997; 91: 505-510Abstract Full Text PDF PubMed Scopus (28) Google Scholar The drug is lipophilic and is prepared as an oil/water emulsion consisting of 1% propofol, 10% soybean oil, 2.25% glycerol, and 1.2% egg lecithin.10Bryson HM Fulton BR Faulds D. Propofol :an update of its use in anaesthesia and conscious sedation.Drugs. 1995; 50: 513-519Crossref PubMed Scopus (319) Google Scholar, 11Diprivan 1%. Astra-Zeneca,, Wilmington, DL2000Google Scholar Propofol is contraindicated in patients with hypersensitivity to egg or soybean. In addition, a generic formulation contains sodium metabisulfite and is contraindicated in patients with sulfite allergies.12Propofol. Baxter Pharmaceutical Products, Inc.,, New Providence, New Jersey2000Google ScholarPropofol has a rapid onset and a short duration of action. Hypnosis is induced within 30-60 seconds of intravenous administration, essentially the time of one arm-brain circulatory pass.8Smith I White PF Nathanson M Gouldson R. Propofol: an update on its clinical use.Anesthesiology. 1994; 81: 1005-1043Crossref PubMed Scopus (569) Google Scholar, 9Marinella JA. Propofol for sedation in the intensive care unit: essentials for the clinician.Respiratory Medicine. 1997; 91: 505-510Abstract Full Text PDF PubMed Scopus (28) Google Scholar The half-life of propofol is 1.8-4.1 minutes. After cessation of infusion, blood concentrations rapidly decline due to rapid tissue distribution and high metabolic clearance.11Diprivan 1%. Astra-Zeneca,, Wilmington, DL2000Google Scholar Clinically this accounts for rapid recovery within 10-30 minutes in most patients after discontinuation of the drug.9Marinella JA. Propofol for sedation in the intensive care unit: essentials for the clinician.Respiratory Medicine. 1997; 91: 505-510Abstract Full Text PDF PubMed Scopus (28) Google ScholarPropofol is 98% plasma-protein bound, and is metabolized primarily in the liver. Propofol potentiates the effects of benzodiazepines, barbiturates, and opioids.9Marinella JA. Propofol for sedation in the intensive care unit: essentials for the clinician.Respiratory Medicine. 1997; 91: 505-510Abstract Full Text PDF PubMed Scopus (28) Google Scholar, 10Bryson HM Fulton BR Faulds D. Propofol :an update of its use in anaesthesia and conscious sedation.Drugs. 1995; 50: 513-519Crossref PubMed Scopus (319) Google Scholar, 13Vuyk J. Pharmacokinetics and pharmacodynamic interactions between opioids and propofol.J Clin Anesth. 1997; 9: 23S-26SAbstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar The pharmacokinetic properties do not significantly change in patients with moderate chronic liver disease or renal failure.8Smith I White PF Nathanson M Gouldson R. Propofol: an update on its clinical use.Anesthesiology. 1994; 81: 1005-1043Crossref PubMed Scopus (569) Google Scholar, 9Marinella JA. Propofol for sedation in the intensive care unit: essentials for the clinician.Respiratory Medicine. 1997; 91: 505-510Abstract Full Text PDF PubMed Scopus (28) Google Scholar, 10Bryson HM Fulton BR Faulds D. Propofol :an update of its use in anaesthesia and conscious sedation.Drugs. 1995; 50: 513-519Crossref PubMed Scopus (319) Google Scholar However, dose reductions are indicated in the elderly and in patients with diminished cardiac output due to decreased clearance of the drug.14Kirkpatrick T Cockshott ID Douglas EJ Nimmo WS. Pharmacokinetics of propofol (Diprivan) in elderly patients.Br J Anaesth. 1988; 60: 146-150Crossref PubMed Scopus (225) Google ScholarEfficacyEGDA randomized study of 40 patients receiving either propofol or midazolam titrated to an equivalent level of sedation prior to endoscopy reported that propofol provided more rapid recovery compared with midazolam, but was associated with pain on injection, a shorter amnesia span, and reduced patient acceptance.15Patterson KW Casey PB Murray JP O'Boyle CA Cunningham AJ. Propofol sedation for outpatient upper gastrointestinal endoscopy: comparison with midazolam.Br J Anaesth. 1991; 67: 108-111Crossref PubMed Scopus (113) Google Scholar In contrast, another study randomized 90 patients to receive either midazolam or propofol administered both before and during the procedure. Patients receiving propofol tolerated endoscopy better, reached a deeper level of sedation, and recovered more rapidly. There was a similar frequency of amnesia for the procedure and perceived patient discomfort.3Carlsson U Grattidge P. Sedation for upper gastrointestinal endoscopy: a comparative study of propofol and midazolam.Endoscopy. 1995; 27: 240-243Crossref PubMed Scopus (158) Google ScholarColonoscopyAn uncontrolled study of 60 patients evaluated different propofol infusion rates after a fixed loading dose during colonoscopy. Patients lost consciousness after a mean of 60.6 seconds and preservation of the hypnotic state was dependent on the infusion rate.16Gepts E Claeys MA Camu F Smekens L. Infusion of propofol (‘Diprivan') as sedative technique for colonoscopies.Postgrad Med J. 1985; 61: 120-126PubMed Google Scholar A small study of 20 subjects using patient-controlled sedation (PCS) with propofol alone or in combination with alfentanil demonstrated feasibility but suggested that propofol alone did not provide adequate analgesia.17Heiman DR Tolliver BA Weis FR O'Brien BL DiPalma JA. Patient-controlled anesthesia for colonoscopy using propofol: results of a pilot study.Southern Med J. 1998; 91: 560-564Crossref PubMed Scopus (26) Google Scholar A double-blinded study randomized 57 patients to one of three groups: diazepam/meperidine, midazolam/fentanyl, or propofol/fentanyl. There were no significant differences in sedation, analgesia, recovery rate or incidence of side-effects.18Kostash MA Johnston R Bailey RJ Konopad EM Guthrie LP. Sedation for colonoscopy: a double-blind comparison of diazepam/meperidine, midazolam/fentanyl and propofol/fentanyl combinations.Can J Gastroenterol. 1994; 8: 27-31Google Scholar Another randomized controlled trial compared sedation with pethidine and diazemuls versus patient-controlled sedation with propofol and alfentanil. Patient controlled sedation provided significantly lighter sedation, less analgesia, and a faster recovery time (10 vs. 40 minutes). All patients were satisfied with their level of sedation.4Roseveare C Seavell C Patel P Criswell J Kimble J Jones C et al.Patient-controlled sedation and analgesia, using propofol and alfentanil, during colonoscopy: a prospective randomized controlled trial.Endoscopy. 1998; 30: 768-773Crossref PubMed Scopus (76) Google Scholar Another study randomly assigned 79 patients to receive either midazolam or midazolam plus propofol. The study results are difficult to interpret due to the concomitant administration of nalbuphine and ketamine.5Reimann FM Samson U Derad I Fuchs M Schiefer B Stange EF. Synergistic sedation with low-dose midazolam and propofol for colonoscopies.Endoscopy. 2000; 32: 239-244Crossref PubMed Scopus (101) Google ScholarERCPTwo studies comparing midazolam to propofol during ERCP have been reported.6Jung M Hofmann C Kiesslich R Brakertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam.Endoscopy. 2000; 32: 233-238Crossref PubMed Scopus (155) Google Scholar, 7Wehrmann T Kokabpick S Lembcke B Caspary WF Seifert H. Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study.Gastrointest Endosc. 1999; 49: 677-683Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar A randomized, controlled, unblinded study of 80 patients found that adequate sedation was possible in 80% of patients with midazolam alone and 97.5% of patients receiving propofol (p<0.01). Recovery times were significantly shorter and sedation was judged by physicians and patients to be significantly better with propofol.6Jung M Hofmann C Kiesslich R Brakertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam.Endoscopy. 2000; 32: 233-238Crossref PubMed Scopus (155) Google Scholar In the second randomized controlled trial involving 198 patients, propofol provided more rapid sedation and significantly better patient cooperation. Recovery time was also significantly shorter with propofol (19 vs. 29 minutes).7Wehrmann T Kokabpick S Lembcke B Caspary WF Seifert H. Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study.Gastrointest Endosc. 1999; 49: 677-683Abstract Full Text Full Text PDF PubMed Scopus (240) Google ScholarCombined studiesPropofol has been evaluated in three studies comprising 545 patients undergoing EGD, colonoscopy and ERCP. The authors concluded that sedation with propofol was comparable to that achieved with conventional agents, while providing for faster recovery time.2Koshy G Nair S Norkus EP Hertan HI Pitchumoni CS. Propofol versus midazolam and meperdine for conscious sedation in GI endoscopy.Am J Gastroenterol. 2000; 95: 1476-1479Crossref PubMed Google Scholar, 19Dubois A Balatoni E Peeters JP Baudoux M. Use of propofol for sedation during gastrointestinal endoscopies.Anaesthesia. 1988; 43: 75-80Crossref PubMed Scopus (53) Google Scholar, 20Tellan G Fegiz A Iannarone C Baumgartner I Navarra M Fantera A. The use of di-hydroxypropylphenol (propophol) in endoscopic procedures.Eur Rev Med Pharmacol Sci. 1998; 3-4: 147-150Google ScholarPediatric usePropofol is not approved for use in children less than 3 years of age.21Susla GM. Propofol toxicity in critically ill pediatric patients: show us the proof.Crit Care Med. 1998; 26: 1959-1960Crossref PubMed Scopus (33) Google Scholar There is limited published experience on the use of propofol for endoscopic sedation in the pediatric population.22Hertzog JH Campbell JK Dalton HJ Hauser GJ. Propofol anesthesia for invasive procedures in ambulatory and hospitalized children: experience in the pediatric intensive care unit.Pediatrics. 1999; 103 ([abstract]): 657Crossref Scopus (83) Google Scholar, 23Rich JB Yaster M Brandt J. Anterograde and retrograde memory in children anesthetized with propofol.Journal of Clinical and Experimental Neuropsychology. 1999; 21: 535-546Crossref PubMed Scopus (19) Google Scholar, 24Lowrie L Weiss AH Lacombe C. The pediatric sedation unit: a mechanism for pediatric sedation.Pediatrics. 1998; 102 ([abstract]): 627Crossref Scopus (99) Google Scholar A retrospective review published in abstract form reported on the successful use of propofol in 115 pediatric patients (mean age 6.4; range 10 days to 20.8 years) undergoing a variety of procedures including endoscopy in an ICU.22Hertzog JH Campbell JK Dalton HJ Hauser GJ. Propofol anesthesia for invasive procedures in ambulatory and hospitalized children: experience in the pediatric intensive care unit.Pediatrics. 1999; 103 ([abstract]): 657Crossref Scopus (83) Google ScholarSafetyPropofol is a respiratory depressant with effects including a reduction in minute ventilation, tidal volume, and functional residual capacity.25Mirenda J Broyles G. Propofol as used for sedation in the ICU.Chest. 1995; 108: 539-548Crossref PubMed Scopus (66) Google Scholar, 26Graber RG. Propofol in the endoscopy suite: an anesthesiologist's perspective.Gastrointest Endosc. 1999; 49: 803-806Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar Three studies involving a total of 300 patients receiving propofol for endoscopic sedation each reported an episode of severe respiratory depression.6Jung M Hofmann C Kiesslich R Brakertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam.Endoscopy. 2000; 32: 233-238Crossref PubMed Scopus (155) Google Scholar, 7Wehrmann T Kokabpick S Lembcke B Caspary WF Seifert H. Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study.Gastrointest Endosc. 1999; 49: 677-683Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar, 20Tellan G Fegiz A Iannarone C Baumgartner I Navarra M Fantera A. The use of di-hydroxypropylphenol (propophol) in endoscopic procedures.Eur Rev Med Pharmacol Sci. 1998; 3-4: 147-150Google Scholar In a small study using propofol for endoscopic sedation, apnea was detected by end-tidal capnography in 6 of 10 patients. This enabled a timely decrease in the propofol infusion avoiding significant oxygen desaturation.27Vargo JJ Zuccaro G Dumot JA Shay SS Conwell DL et al.Gastroenterologist-administered propofol for therapeutic upper endoscopy with graphic assessment of respiratory activity.Gastrointest Endosc. 2000; 52: 250-255Abstract Full Text Full Text PDF PubMed Scopus (74) Google ScholarThe predominant cardiovascular effect of propofol is a reduction in the systemic vascular resistance, which may induce hypotension.28Turner RJ Gatt SP Kam A Ramzan I Daley M Administration of a crystalloid fluid preload does not prevent the decrease in arterial blood pressure after induction of anaesthesia with propofol and fentanyl.Br J Anaesth. 1998; 80: 737-741Crossref PubMed Scopus (31) Google Scholar When used for general anesthesia, hypotension (systolic blood pressure under 90mmHg) occurred in 15.7% and bradycardia (heart rate below 50) in 4.8% of patients.29Hug CC McLeskey CH Nahrwold ML Roizen MF Stanley TH Thisted RA et al.Hemodynamic effects of propofol: data from over 25,000 patients.Anesth Analg. 1993; 77: S21-S29PubMed Google ScholarInfections have been reported with the use of contaminated propofol.30Anonymous MMWR. 1990; 39: 426-427PubMed Google Scholar, 31Bennett SN McNeil MM Bland LA Arduino MJ Villarino ME Perotta DM et al.Post-operative infections traced to contamination of an intravenous anesthetic propofol.N Engl J Med. 1995; 333: 147-154Crossref PubMed Scopus (443) Google Scholar, 32Veber B Gachot B Bedos JP Wolff M. Severe sepsis after intravenous injection of contaminated propofol.Anesthesiology. 1994; 80: 712-713Crossref PubMed Scopus (64) Google Scholar Due to the rapid growth of organisms in this lipid based medium at room temperature, techniques to minimize contamination are critical. These include adherence to aseptic techniques, avoidance of reusing a syringe, use of propofol within 6 hours of original withdrawal from an ampule, and refrigeration.33Patterson JS Hopkins KJ Albanese R. Propofol handling techniques.Acta Anaesthesiol Scand. 1991; 35: 370Crossref PubMed Scopus (2) Google Scholar, 34Bach A Motsch J. Infectious risk associated with the use of propofol.Acta Anaesthesiol Scand. 1996; 40: 1189-1196Crossref PubMed Scopus (16) Google ScholarIntravenous propofol given by peripheral vein has been reported to cause pain on injection in 30-90% of patients. Reported techniques to minimize this effect include warming the drug to body temperature, dilution, use of lidocaine, or concomitant administration of select sedatives.35Fletcher GC Gillespie JA Davidson JAH. The effect of temperature upon pain during injection of propofol.Anesthesia. 1996; 51: 498-499Crossref PubMed Scopus (36) Google Scholar, 36Smith AJ Power I. The effect of pretreatment with ketorolac on pain during intravenous injection of propofol.Anaesthesia. 1996; 51: 883-885Crossref PubMed Scopus (20) Google Scholar, 37Angst MS Mackey SC Zupfer GH Tataru CD Brock-Utne JG. Reduction of propofol injection pain with a double lumen IV set.J Clin Anesth. 1997; 9: 462-466Abstract Full Text PDF PubMed Scopus (16) Google Scholar, 38Pang WW Mok MS Huang S Hwang MH. The analgesic effect of fentanyl, morphine, meperidine, and lidocaine in the peripheral veins: a comparative study.Anesth Analg. 1998; 86: 382-386PubMed Google Scholar, 39Ho CM Tsou MY Sun MS Chu CC Lee TY. The optimal effective concentration of lidocaine to reduce pain on injection of propofol.J Clin Anesth. 1999; 11: 296-300Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 40Sadler PJ Thompson HM Maslowski P Liddle A Rowbotham DJ. Iontophorectically applied lidocaine reduces pain on propofol injection.Br J Anaesth. 1999; 82: 432-434Crossref PubMed Scopus (25) Google ScholarTwenty five cases of pancreatitis associated with proprofol use were reported to the food and drug administration by 1996.41Leisure GS O'Flahery J Green L Jones DR. Propofol and post-operative pancreatitis.Anesthesiology. 1996; 84: 224-227Crossref PubMed Scopus (65) Google Scholar The mechanism of pancreatitis with propofol has not been established but a causality link is regarded as probable.42Kumar AN Schwartz DE Lim KG. Propofol-induced pancreatitis: recurrence of pancreatitis after rechallenge.Chest. 1999; 115: 1198-1199Crossref PubMed Scopus (65) Google ScholarCostsThe direct cost of medication is increased with propofol compared to opioid and benzodiazepine sedation.4Roseveare C Seavell C Patel P Criswell J Kimble J Jones C et al.Patient-controlled sedation and analgesia, using propofol and alfentanil, during colonoscopy: a prospective randomized controlled trial.Endoscopy. 1998; 30: 768-773Crossref PubMed Scopus (76) Google Scholar, 26Graber RG. Propofol in the endoscopy suite: an anesthesiologist's perspective.Gastrointest Endosc. 1999; 49: 803-806Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar The additional cost of monitoring and personnel for sedation has not been weighed against the shortened recovery time or other indirect patient costs.SummaryTabled 1Cost of Sedative Drugs26Graber RG. Propofol in the endoscopy suite: an anesthesiologist's perspective.Gastrointest Endosc. 1999; 49: 803-806Abstract Full Text Full Text PDF PubMed Scopus (77) Google ScholarDrugAmountCostMorphine10mg$0.51Meperidine100mg$0.41Fentanyl100μg$0.24Midazolam5mg$9.33Propofol200mg$10.20 Open table in a new tab Technology status evaluation report November, 2000 IntroductionIn order to promote the appropriate use of new or emerging endoscopic technologies, the ASGE Technology Committee has developed a series of status evaluation papers. By this process relevant information about these technologies may be presented to practicing physicians for the education and care of their patients. In many cases, data from randomized controlled trials is lacking and only preliminary clinical studies are available. Practitioners should continue to monitor the medical literature for subsequent data about the efficacy, safety and socioeconomic aspects of the technologies.
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