Conscious Sedation Art Wallace, M.D., Ph.D. Professor of Anesthesiology and Perioperative Medicine Chief of Anesthesia Service SF VAMC Art.wallace@med.va.gov wallacea@anesthesia.ucsf.edu awallace@cardiacengineering.com Objectives Discuss classes of sedatives Discuss conscious sedation Go over a few cases and suggest management plans Disclaimer Discuss off label use of FDA approved medications Consultant for Conmed Corporation. Consultant to Nihon Kohden Developer of ECOM. Developer of AVD. Developer of AVD-R. Developer of perioperative beta blockade and PCRRT. Conscious Sedation: What is it? Conscious Sedated Not Unconscious Responsive Breathing Stable Hemodynamics Cooperative Positive Memory Does not develop PTSD Conscious Sedation: What it isn’t Unconscious General Anesthesia Unresponsive Hypoxic Unstable Hemodynamics (tachycardia) Disinhibition Duct Tape and Leather Straps PTSD Inducing Anxiety Components of Anesthesia Memory Autonomics Consciousness Pain Placebo Effect Movement Conscious Sedation: Methods Local Anesthesia No pharmacologic sedative agents Audiovisual Distraction Pharmacology Nitrous: MAC = 107% Benzodiazepines (valium, midazolam) Narcotics (fentanyl, morphine, demerol) Barbiturates (methohexital, thiopental, propofol) Tranquilizers (droperidrol) Alpha-2 agonists (dexmedetomidine, clonidine) Autonomic blockers (propranolol, atenolol) Conscious Sedation: Requirements Privileges and Training Monitoring Oxygen Resuscitative Equipment Preoperative Evaluation NPO Recovery Post OP Instructions Follow UP Controlled substances Abuse potential Risk of death, hypoxia, etc. ASA Classification Non-linear scale of operative risk. Highly correlated with perioperative outcome. ASA 1 Nothing wrong with patient ASA 2 One medical problem (CIG, HTN) ASA 3 Systemic disease that will limit life (CAD, COPD, DM) ASA 4 Systemic disease that could limit life to a year (CHF, U/A, ICU, Multiple Intubations for COPD, ESRD) ASA 5 Patient will die in 24 hours regardless of medical care. E: Emergency What we worry about Plastic Surgery Deaths: Looks to Die For Only a month after Olivia Goldsmith died at Manhattan Eye, Ear and Throat, there’s been another death during a face-lift. Inside a hospital in crisis. Olivia Goldsmith, the best-selling author of The First Wives Club and ten other pop-feminist novels, checked into the Manhattan Eye, Ear and Throat Hospital on January 7 for what has been described as minor plastic surgery—a chin-tuck. Conscious Sedation: No sedative pharmacologic agents Smooth talking, reassurance, and comfort (Lamaze) Who stops breathing from talk? Conscious Sedation: No sedative pharmacologic agents Audiovisual Distraction Conscious Sedation: Nitrous MAC 107% Little effect on memory Laughing gas Rapid onset and offset. Limited potency Patents have worn off, so no drug reps to push, no free lunch and or pens. How many drugs come from a pipe in the wall? Conscious Sedation: Benzodiazepines Diazepam (Valium®) 2-10 mg IV/IM q 3-4 hours or 2-10 mg PO TID-QID (t1/2 = 2080 hours Midazolam (Versed ®) 1 mg IV q 2-3 min or 5 mg IM Lorazepam (Ativan ®) 0.5 -2 mg PO/IM/IV q 6-8 hours Benzodiazepines and the World Economy 1864 Barbiturates Barbital, Phenobarbitol (Bayer) 1893’s Methamphetamines (Japan, Germany) Pervitin, Fliegerschokolade ("flyer's chocolate") when given to pilots, Panzerschokolade ("tanker's chocolate") when given to tank crews. 1963 Benzodiazepines (chlordiazepoxide (Valium, Librium (equilibrium))) (Hoffman La Roche) 1988 Selective Serotonin Reuptake Inhibitors (Prozac) (Eli Lilly not Swiss) Barbituates & Alcohol Marilyn Monroe was found dead in the bedroom of her Brentwood, California home by her live-in housekeeper Eunice Murray on August 5, 1962. She was 36 years old at the time of her death. Her death was ruled to be "acute barbiturate poisoning" Benzodiazepines Permeate Medicine Classical benzodiazepines bromazepam (Lexotanil or Lexotan) clonazepam (Klonopin) clorazepate (Tranxene) chlordiazepoxide (Librium) diazepam (Valium) flurazepam (Dalmane) lorazepam (Ativan or Temesta) nitrazepam (Mogadon) oxazepam (Serax) temazepam (Restoril) tetrazepam (Mylostan) Other benzodiazepines alprazolam (Xanax) estazolam (ProSom) flunitrazepam (Rohypnol) lormetazepam (Loramet) mexazolam (Sedoxil) midazolam (Dormicum) triazolam (Halcion) Mother's Little Helper Written by Mick Jagger and Keith Richards, "Mother's Little Helper" was recorded in Los Angeles from 3 to 8 December 1965. The song deals with the widespread use of the prescription drug Valium, invented by Polish chemist Leo Sternbach. From the early 60's to the early 80's it was one of the most heavily prescribed drugs in the US and Europe. The song sheds a light on the darker perspective of its use among housewives, intoning: “Kids are different today, I hear ev'ry mother say Mother needs something today to calm her down And though she's not really ill, there's a little yellow pill She goes running for the shelter of a mother's little helper And it helps her on her way, gets her through her busy day” “Life's just much too hard today / I hear ev'ry mother say / The pursuit of happiness just seems a bore / And if you take more of those / you will get an overdose / No more running for the shelter / of a mother's little helper Valium has Permeated Our Culture Buy valium without a prescription Happy mother of adopted baby? Benzodiazepines are Driven By Economics Number one prescription in 1960-70’s Major income source for Switzerland Patent expired Now what? Conscious Sedation: Reversal of Benzodiazepines Flumazenil (Romazicon ®) 0.2 mg IV q min prn sedation. Max dose 3.0 mg per series or 3 mg/hr. If you reverse you have to monitor for resedation as flumazenil wears off. Conscious Sedation: Narcotics Drug Dose Onset Offset Metabolism Meperidine (Demerol) 100 mg 15 minutes 3 hours 200 minutes Methadone 10 mg 30 minutes 6-12 hours 300 minutes Morphine 10 mg 20 minutes 4 hours 210 minutes Heroine 4 mg 3 minutes 4 hours 3 minutes Hydromorphone 2 mg (Dilaudid) 20 minutes 4 hours 180 minutes Alfentanyl 1 mg 90 seconds 20 minutes 90 minutes Fentanyl 100 mcg 240 seconds 40 minutes 240 minutes Remifentanyl 100 mcg 15 seconds 5 minutes 5 minutes Sufentanil 10 mcg 180 seconds 30 minutes 180 minutes Redistribution There are only two answers in anesthesia: Clinical: Consider ABC Airway, Breathing, Circulation. Pharmacologic: Must be Redistribution Redistribution Drug X mg Volume of Distribution = Y liters Final Concentration = X mg/liter How do I get the drug to “go away” before it is metabolized? Redistribution 100 mg Drug 20, 10, 5, 2.5, 1.25, 0.6, 0 20% 50, 25, 12, 6, 3, 1, 0 10, 5, 2, 1, 0 10% 10% 10% 10, 5, 2, 1, 0 10, 5, 2, 1, 0 50, 25, 12, 6, 3, 1, 0 Other Drug disappears from circulation long before any is metabolized because it is distributed in tissues with high blood flow. 50% 50, 25, 12, 6, 3, 1, 0 Fat Bone •Distribution of blood flow depends on exercise, pregnancy, digestion, etc. •No Blood Flow – No drug •Circulation time = 1 minute Conscious Sedation: Narcotics Drug Dose Onset Offset Metabolism Meperidine (Demerol) 100 mg 15 minutes 3 hours 200 minutes Methadone 10 mg 30 minutes 6-12 hours 300 minutes Morphine 10 mg 20 minutes 4 hours 210 minutes Heroine 4 mg 3 minutes 4 hours 3 minutes Hydromorphone 2 mg (Dilaudid) 20 minutes 4 hours 180 minutes Alfentanyl 1 mg 90 seconds 20 minutes 90 minutes Fentanyl 100 mcg 240 seconds 40 minutes 240 minutes Remifentanyl 100 mcg 15 seconds 5 minutes 5 minutes Sufentanil 10 mcg 180 seconds 30 minutes 180 minutes Conscious Sedation: Narcotics Toxicity Death Respiratory arrest Respiratory depression CO2 retention Nausea and Vomiting Puritis (my nose itches) Allergy Constipation Addiction Diversion Narcotic Toxicity and Diversion On Oct, 25, 2013: 23,818 people reported to have side effects when taking Oxycodone. Among them, 1,053 people (4.42%) have Death. Time on Oxycodone when people have Death * : <1 month Death 1-6 months 6 - 12 months 69.77% 23.26% 0.00% 1-2 years 2-5 years 5 - 10 years 10+ years 2.33% 4.65% 0.00% 0.00% Narcotic Toxicity and Diversion Growth in Overdose Deaths and Treatment Admissions, 2001-2006 "According to the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics, unintentional overdose deaths involving prescription opioids increased 114 percent from 2001 (3,994) to 2005 (8,541), the most recent nationwide data available. Further, the number of treatment admissions for prescription opioids as the primary drug of abuse increased 74 percent from 46,115 in 2002 to 80,131 in 2006, the most recent data available, according to the SAMHSA Treatment Episode Data Set (TEDS) "Moreover, the estimated cost of CPD diversion and abuse to public and private medical insurers is $72.5 billion a year. Conscious Sedation: Narcotics Reversal Narcan Vial has either 0.4 or 1.0 mg Can be titrated in 40 mcg doses to effect. Can be given IV or IM Duration 40 minutes: You must monitor for resedation. Can cause withdrawal phenomena Conscious Sedation: Narcotics Reversal Narcan 0.4- 2 mg IV or IM Naltrexone 50 mg po qd If you reverse, now what? Monitor in conscious sedation area for longer than half life of drug. You are NOT mandated to admit to the ICU. We look at the use of reversal agents. If you need to reverse, REVERSE. Conscious Sedation: “Barbiturates” Sodium thiopental Methohexital Propofol (10 – 200 mcg/kg/min IV) Conscious Sedation: Propofol Anti-emetic Milk of Amnesia Coffee Creamer that is also an aphrodisiac Burning on injection Must be kept sterile (like intralipid) Really an anesthetic Wears off by redistribution or metabolism. No reversal Less effective in patients with alcohol exposure. Causes respiratory depression or arrest. Can cause hemodynamic collapse or arrest. Not for use by amateurs. Propofol: Lots of people play home anesthesiologist. They end up dead. No monitors, no IV, not NPO, no anesthesiologist. Sedasys The FDA has given premarket approval to the Sedasys® Computer-Assisted Personalized Sedation System, developed by Ethicon Endo-Surgery Inc. The device has the potential to “redefine sedation delivery”, according to Ethicon’s press release, with propofol sedation “personalized to the needs of each patient, by precisely integrating drug delivery and comprehensive patient monitoring.” The Sedasys device is designed for “healthy” adult patients who undergo colonoscopy and esophagogastroduodenoscopy (EGD) procedures electively. Sedasys Ethicon expects to introduce the system into clinical practice on a limited basis in 2014 to address “the growing preference for propofol sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases.” According to the FDA’s overview, the Sedasys is a “firstof-a-kind device that will allow non-anesthesia practitioners to administer propofol during colonoscopy and EGD procedures.” It links clinical monitors to an IV infusion pump, and will automatically modify or stop the infusion if it detects “signs associated with oversedation” such as oxygen desaturation. Sedasys The goal here is to make colonoscopies and EGDs cheaper by allowing people other than qualified anesthesia practitioners to administer propofol. The FDA has given everyone its blessing to ignore the propofol package insert’s warning that propofol “should be administered only by persons trained in the administration of general anesthesia.” The FDA appears to think it will be enough for GI teams to take part in a “simulation-based moderate sedation training program” that will provide “expert instruction in the pharmacology of propofol and airway management.” Sedasys Robotic anesthesiologist. Controls propofol infusion based on vital signs. Sedasys I like robots. Sedasys is a robot anesthesiologist. In the movies, they don’t always turn out so well. Conscious Sedation: Droperidrol Tranquilizer Anti-emetic (0.625 mg IV PRN NAUSEA) Innovar (fentanyl 50 mcg/cc + droperidrol 2.5 mcg/cc) Neurolept Anesthesia (Benzodiazepine + Narcotic + Droperidrol) Droperidol currently carries a warning about cases of sudden death at high doses (greater than 25 mg) in patients at risk for cardiac arrhythmias. QT prolongation Prolonged QT may lead to torsades de pointes Requires ECG pre and post and ECG monitoring post use. Do not use in patients with prolonged QT. Conscious Sedation: Dexmedetomidine Alpha-2 agonist 1500 : 1 Alpha-2 to Alpha-1 ratio. Responsive yet cooperative Mental duct tape No effect on memory Zombie Decrease epinephrine and norepinephrine levels O.2 to 0.7 mcg/kg/hour Less delirium post sedation Conscious Sedation: Make sure they are really conscious Audiovisual Distraction works. Less can be more: Disinhibition is a problem Many experts agree that chronic breathing is good. Measure the blood pressure, heart rate, oxygen saturation Beta blockers for heart rate control. Monitor Pulse oximeter is a poor man’s cardiac output monitor Oxygen has been berry, berry, good to me. Reversal: narcan for narcotics Flumazenil for benzodiazepines Monitoring has been very, very good to us. Closed Claims Database 1988: 50% reduction #1 in malpractice claims for encephalopathy with anesthesia. 1992: 50% reduction #2 in malpractice claims for encephalopathy with anesthesia. 1988: Pulse oximeter 1992: Capnography (Exhaled Carbon Dioxide sensor) Malpractice $ Deaths from Anesthesia 1988 1992 Time Conscious Sedation: Cases IV Drug Abuser What drug does he use? How much does he use? When did he use last? Can we switch classes of agents? Why throw more salt in the sea? Conscious Sedation: Cases Alcoholic Is he drunk now? Is he going into withdrawal? Is he going to go into withdrawal? When did he drink last? Can we switch classes of agents? Conscious Sedation: Cases Patient with dementia Is he going to fight with us? Is he going to get agitated? How do I make it comfortable for patient who can’t understand? How do I make it possible for physician to work? How do I sedate a violent patient? Conscious Sedation: Cases VA Patient A HTN CAD COPD BPH GERD Hiatal Hernia Obesity Hypercholesterolemia VA Patient B Patient A with diabetes Please list diseases he doesn’t have, it will save time. Conscious Sedation: Cases VA Patient B HTN, CAD, COPD, BPH, GERD, Hiatal Hernia, Obesity, Hypercholesterolemia HONDA: Hypertensive, Obese, Non Compliant, Diabetic Alcoholic. Monitor up the Wazoo! Beta Blockers and/or Clonidine for anti-ischemia prophylaxis. Local or Regional Anesthesia Do no harm Conscious Sedation: Make sure they are really conscious : Less is more. Local, Topical, Regional Anesthesia Audiovisual Distraction MONITOR! Beta blockers for heart rate control. Pulse oximeter is a poor man’s cardiac output monitor Oxygen has been berry, berry, good to me. Reversal: narcan for narcotics Flumazenil for benzodiazepines