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Oral sedation using Midazolam in patients with Alzheimer's disease

UNICAMP. University of Campinas Piracicaba Dental School, Brazil. Oral sedation using Midazolam in patients with Alzheimer's disease. Prof. Dr. Eduardo Hebling Associate Professor Coordinator of Geriatric Dentistry Specialty Program hebling@fop.unicamp.br. 26 TH Annual Meeting of SCD

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Oral sedation using Midazolam in patients with Alzheimer's disease

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  1. UNICAMP University of Campinas Piracicaba Dental School, Brazil Oral sedation using Midazolam in patients with Alzheimer's disease Prof. Dr. Eduardo Hebling Associate Professor Coordinator of Geriatric Dentistry Specialty Program hebling@fop.unicamp.br 26TH Annual Meeting of SCD Chicago – April 12, 2014

  2. UNICAMP Alzheimer`s Disease (AD) • Most common form of dementia among the elderly; • Progressive degenerative brain disorder that seriously affects a person’s ability to carry out their daily life activities; Jicha & Carr, 2010 • 2050: project to reach 106.8 million worldwide (affecting 1 in 85 people globally); • The disease is a growing public health concern with major socioeconomic burden. Brookmeyeret al., 2007 Senile plaques Font: www.google.com.br

  3. UNICAMP Alzheimer`s Disease (AD) Global Deterioration Scale (Reisberg, 1982 ) 1: No cognitive decline • The dementia starts slowly. First affects the parts of the brain that control the thought, the memory and the language; • People with AD may have difficulty to recall recent events or names of people who know; • Over the time, the symptoms worsen; • There is no cure for the disease; • Some drugs can help prevent the symptoms becoming worse. 2: Very mild cognitive decline 3: Mild cognitive decline 4: Moderate cognitive decline 5: Moderately severe cognitive decline 6: Severe cognitive decline 7: Very severe cognitive decline

  4. UNICAMP Dental Care Manegement Alzheimer’s Disease (AD) Lack of compliance and cooperation for the treatment Oral Sedation Difficulties of care Ettinger R.F., 1992

  5. Oral Sedation Special Care Dent. 1999; 19(2):56-63. Matear DW, Clarke D. • Advantages • Almost universal acceptability; • Ease of administration; • Low cost; • Decreased incidence of adverse reactions; • Decreased severity of adverse reactions; • No needles, syringes, equipment; • No specialized training requirements. • Disadvantages • Reliance on patient compliance; • Prolonged latent period; • Erratic and incomplete absorption of drugs • from the gastrointestinal tract; • Inability to titrate; • Inability to readily lighten or deepen the level • of sedation; • Prolonged duration of action.

  6. UNICAMP • Midazolam Maleate • Benzodiazepine drug with fast onset (30-60 • minutes), short duration (60 minutes), prompt • rate of half-life elimination (1.5 to 2.5 hr); • Sedative, anxiolytic, anticonvulsant and muscle • relaxant properties; • Low toxicity level; • Hepatic metabolized and renal elimination; • Induce a short duration amnesia; • Low cost; • Easy use (oral via, one hour before the dental • treatment) • Flumazenil, a benzodiazepine antagonist drug, • can be used to treat an overdose or to reverse • the sedation (IV: 0.1-0.4 mg/h in 5% glucose) Yuan et al., 1999 Girdler et al., 2002

  7. UNICAMP To determine acceptance, safety and efficacy of oral Midazolam for conscious sedation in patients with Alzheimer’s Disease undergoing dental treatment. Objective

  8. UNICAMP Material and Methods • Case report study • Approved by Ethical Committee at University of Campinas • Informed consent was obtained from the family of all patients • Developed in dentate elderly with Alzheimer’s Disease • Living in a Brazilian long-stay institution • Total population: 450 elderly

  9. UNICAMP Material and Methods • Inclusion Criteria: • - Alzheimer’s Disease • Stages 6 to 7 (Reisberg’s Scale): severe to very severe cognitive decline • ASA IV Physical status classification system adopted by the American Society of Anesthesiologists (ASA), 1963 A patient without systemic disease; a normal healthy patient. ASA I A patient with mild systemic disease. ASA II A patient with severe systemic disease that limits activity, but is not incapacitating. ASA III ASA IV A patient with incapacitating systemic disease that is a constant threat to life. A moribund patient not expected to survive 24 hours with or without operation. ASA V Emergency operation of any variety; E precedes the number indicating the patient`s physical status (e.g., ASA E-IV). ASA E

  10. UNICAMP Material and Methods • Exclusion Criteria: • Presence of respiratory disease(e.g., asthma, cystic fibrosis, emphysema, • chronic obstructive pulmonary disorder –COPD) • Hypersensitivity by Midazolam • Previous use of some drugs: • - Macrolide antibiotics (e.g., Azithromycin, Clarithromycin, Erythromycin) • - Ketaconazole(antifungal drug) • - Itraconazole(antifungal drug) • - Ritonavir(antiretroviral drug) • - Amprenavir(antiretroviral drug) • - Nelfinavir(antiretroviral drug) • - Nefazodone(antidepressant drug) • - Rifampin(antibiotic for nonviral infections, such as tuberculosis) • - Carbamazepine(anticonvulsant) • - Phenytoin(anticonvulsant and cardiac antiarrhythmic) Absolute Contraindications May cause decreased effect of Midazolam Yuan R, Flockhart DA, Balian JD. Pharmacokinetic and pharmacodynamic consequences of metabolism-based drug interactions with alprazolam, midazolam, and triazolam. J Clin Pharmacol. 1999; 39(11): 1109-1125.

  11. UNICAMP Material and Methods • Sedation: Midazolam oral (15 mg), one hour before Guo T, Mao GF, Xia DY, Su XY, Zhao LS. Pharmacokinetics of midazolam tablet in different Chinese ethnic groups. J Clin PharmTher. 2001; 36(3): 406-411. Romano MM, Soares MS, Pastore CA, Tornelli MJ, de Oliveira Guaré R, Adde CA. A study of effectiveness of midazolam sedation for prevention of myocardial arrthymias in endosseous implant placement. Clin Oral Implant Res. 2012; 23(4): 489-495. The author show no conflict of interest Sjövalls S, Kanto J, Kangas L, Pakkanen A. Comparison of midazolam and flunitrazepam for night sedation. Anaesthesia 1982, 37: 924–928.

  12. UNICAMP Material and Methods • Sedation level: was measured • by Ramsay Sedation Scale • Local anesthesia: 2% lidocaine • with 1:100,000 epinephrine • Ramsay Sedation Scale • Level 1: Patient is anxious and agitated or restless, or both. • Level 2: Patient is co-operative, oriented, and calm. • Level 3: Patient responds to commands only. • Level 4: Patient exhibits brisk response to light glabellar • tap or loud auditory stimulus. • Level 5: Patient exhibits an sluggish response to light • glabellar tap or loud auditory stimulus. Level 6: Patient exhibits no response.

  13. UNICAMP Material and Methods • Pulse oximeter: • Blood pressure (mmHg) • Heart rate (beats/min) • Respiratory rate (breaths/min) • Saturation of peripheral oxygen (SpO2) • Sedation and behavioral scores were • recorded every minute.

  14. UNICAMP Material and Methods • Security Parameters: • Hypoxemia: SPO2< 90%, 15 seconds • Bradycardia: heart rate < 60 beats/min • Tachycardia: heart rate > 100 beats/min • Hypotension: decrease of 20% or more in basal systolic • arterial pressure rate (BSAP) • Hypertension: increase of 20% or more in basal systolic • arterial pressure rate (BSAP) Jorgensen JS, Schmid ER, Konig V, Faisst K, Huch A, Huch R. Limitations of forehead pulse oximetry. J Clin Monit.1995; 11(4):253-256. Pedersen T, Dyrlund Pedersen B, Møller AM. Pulse oximetry for perioperative monitoring (Cochrane Review). In: The Cochrane Library. Issue 1; 2007.

  15. UNICAMP Material and Methods Statistical Analysis • Analysis of variance for repeated measures: to compare • changes in variable values across time; • Neuman-Keulspost hoc test: for comparison between pairs of • means where the analysis of variance results were significant • (P <0.05) • Linear regression: to determine the correlation coefficients • Results was expressed by means ± SD

  16. UNICAMP Results • A total of 65 patients (26 males and 39 females) • Mean age of 72 years • The heart and respiratory mean rates for both gender were • similar and within acceptable limits

  17. UNICAMP Results • The lowest mean of saturation of peripheral oxygen (SPO2) was 91 % (SD=± 1.7), ranging 91 to 97 %, within safe limits. • Reference Scores of Acute Respiratory Distress (ARD) • Pressure of arterial oxygen (PaO2) • < 60 mmHg • Saturation of peripheral oxygen (SPO2) • < 90 % • > 50 mmHg • Partial arterial pressure of CO2 (PaCO2) Pedersen T, Dyrlund Pedersen B, Møller AM. Pulse oximetry for perioperative monitoring (Cochrane Review). In: The Cochrane Library. Issue 1; 2007.

  18. UNICAMP Results • Level of sedation ranged of 2 to 5. • Only one patient showed low • sedation level due to concomitant • use of Lorazepam in only one • session. • Time of drug action after the • dental care: 40 (± 15) minutes • Ramsay Sedation Scale • Level 1: Patient is anxious and agitated or restless, or both. • Level 2: Patient is co-operative, oriented, and calm. • Level 3: Patient responds to commands only. • Level 4: Patient exhibits brisk response to light glabellar • tap or loud auditory stimulus. • Level 5: Patient exhibits an sluggish response to light • glabellar tap or loud auditory stimulus. Level 6: Patient exhibits no response.

  19. UNICAMP Results • Local anesthesia and extractions were 90% of the treatments • Of the 195 dental care sessions: • 92% were performed with total acceptance, • 6% with doubtful acceptance, • 2% no treatment could be performed. • No complications were registered during or after the dental • care treatment.

  20. UNICAMP Starting the dental care One hour before Ending the dental care Ramsey Level 1 (anxious, agitated, restless ) Ramsey Level 2 (co-operative, calm, oriented) Ramsey Level 2 maintained 01 hour After 40 minutes Note: Permission of the family to display images on this patient End of sedation

  21. UNICAMP Conclusion Oral Midazolam is a safe and effective method of sedation for dental care in elderly with Alzheimer`s Disease.

  22. UNICAMP University of Campinas Piracicaba Dental School, Brazil Prof. Dr. Eduardo Hebling hebling@fop.unicamp.br

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