Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial.

BACKGROUND: Dexmedetomidine (DEX) is increasingly being used as a sedative for monitored anesthesia care (MAC) because of its analgesic properties, "cooperative sedation," and lack of respiratory depression. In this randomized, multicenter, double-blind, Phase III Food and Drug Administration study, we evaluated the safety and efficacy of two doses of DEX for sedation of patients undergoing a broad range of surgical or diagnostic procedures requiring MAC. METHODS: Three hundred twenty-six patients were randomized 2:2:1 to DEX 0.5 microg/kg, DEX 1 microg/kg, or saline placebo initial loading dose, followed by a maintenance infusion of 0.2-1.0 microg x kg(-1) x h(-1) of DEX (or equivalent volume of saline) titrated to a targeted level of sedation (< or = 4 on the Observer's Assessment of Alertness/Sedation Scale [OAA/S]). Study drug was started at least 15 min before placement of regional or local anesthetic block. Midazolam was given for OAA/S > 4 and fentanyl for pain. The primary end-point was the percentage of patients not requiring rescue midazolam. RESULTS: Significantly fewer patients in the 0.5- and 1-microg/kg DEX groups required supplemental midazolam compared with placebo (59.7% [80/134], 45.7% [59/129] vs 96.8% [61/63], respectively; P < 0.001) and at lower doses to achieve an OAA/S < or = 4 before and during surgery compared with the saline group (1.4 and 0.9 mg vs 4.1 mg, respectively; P < 0.001, each group compared with placebo). Both DEX groups required significantly less fentanyl (84.8 and 83.6 microg vs 144.4 microg, respectively; P < 0.001, for both DEX groups versus placebo) for all surgical subtypes. Anesthesiologists indicated significantly increased ease of achieving and maintaining targeted sedation in both DEX groups compared with placebo with midazolam (P < 0.001). Patient satisfaction was significantly higher with DEX (P < or = 0.009, both groups versus placebo). Common adverse events with DEX were protocol-defined bradycardia and hypotension that were predominately mild to moderate in severity. The incidence of clinically significant respiratory depression (defined as a respiratory rate of < 8 or an oxygen saturation of < 90%) was lower in DEX-treated patients (P = 0.018, for both groups versus placebo). CONCLUSIONS: DEX is an effective baseline sedative for patients undergoing MAC for a broad range of surgical procedures providing better patient satisfaction, less opioid requirements, and less respiratory depression than placebo rescued with midazolam and fentanyl.

Adverse event reporting: lessons learned from 4 years of Florida office data.

BACKGROUND: Patient safety regulations and medical error reporting systems have been at the forefront of current health care legislature. In 2000, Florida mandated that all physicians report, to a central collecting agency, all adverse events occurring in an office setting. PURPOSE: To analyze the scope and incidence of adverse events and deaths resulting from office surgical procedures in Florida from 2000 to 2004. METHODS: We reviewed all reported adverse incidents (the death of a patient, serious injury, and subsequent hospital transfer) occurring in an office setting from March 1, 2000, through March 1, 2004, from the Florida Agency for Health Care Administration. We determined physician board certification status, hospital privileges, and office accreditation via telephone follow-up and Internet searches. RESULTS: Of 286 reported office adverse events, 77 occurred in association with an office surgical procedure (19 deaths and 58 hospital transfers). There were seven complications and five deaths associated with the use of intravenous sedation or general anesthesia. There were no adverse events associated with the use of dilute local (tumescent) anesthesia. Liposuction and/or abdominoplasty under general anesthesia or intravenous sedation were the most common surgical procedures associated with a death or complication. Fifty-three percent of offices reporting an adverse incident were accredited by the Joint Commission on Accreditation of Healthcare Organizations, American Association for Accreditation of Ambulatory Surgical Facilities, or American Association for Ambulatory Health Care. Ninety-four percent of the involved physicians were board certified, and 97% had hospital privileges. Forty-two percent of the reported deaths were delayed by several hours to weeks after uneventful discharge or after hospital transfer. CONCLUSIONS: Requiring physician board certification, physician hospital privileges, or office accreditation is not likely to reduce office adverse events. Restrictions on dilute local (tumescent) anesthesia for liposuction would not reduce adverse events and could increase adverse events if patients are shifted to riskier approaches. State and/or national legislation establishing adverse event reporting systems should be supported and should require the reporting of delayed deaths.

Risks and benefits of anticoagulant and antiplatelet medication use before cataract surgery.

OBJECTIVE: To estimate the risks and benefits associated with continuation of anticoagulants or antiplatelet medication use before cataract surgery. DESIGN: Prospective cohort study. PARTICIPANTS: Patients 50 and older scheduled for 19,283 cataract surgeries at nine centers in the United States and Canada between June 1995 and June 1997. INTERVENTION: None. MAIN OUTCOME MEASURES: Intraoperative and postoperative (within 7 days) retrobulbar hemorrhage, vitreous or choroidal hemorrhage, hyphema, transient ischemic attack (TIA), stroke, deep vein thrombosis, myocardial ischemia, and myocardial infarction. RESULTS: Before cataract surgery 24.2% and 4.0% of patients routinely used aspirin and warfarin, respectively. Among routine users, 22.5% of aspirin users and 28.3% of warfarin users discontinued these medications before surgery. The rates of stroke, TIA, or deep vein thrombosis were 1.5/1000 among those who did not use aspirin or warfarin and 3.8/1000 surgeries among routine users of aspirin and warfarin who continued their medication before surgery. The rate was 1 event per 1000 surgeries among those who discontinued aspirin use (relative risk = 0.7, 95% confidence interval = 0.1-5.9). There were no events among warfarin users who discontinued use. The rates of myocardial infarction or ischemia were 5.1/1000 surgeries (aspirin) and 7.6/1000 surgeries (warfarin) among routine continuous users and no different from those of routine users who discontinued use. CONCLUSIONS: The risks of medical and ophthalmic events surrounding cataract surgery were so low that absolute differences in risk associated with changes in routine anticoagulant or antiplatelet use were minimal.