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1.
Anesthesiology ; 103(2): 269-73, 2005 Aug.
Article in English | MEDLINE | ID: mdl-16052108

ABSTRACT

BACKGROUND: This study evaluated the ability of dexmedetomidine to provide analgesia and sedation for outpatient colonoscopy, examining outcomes including cardiorespiratory variables, side effects, and discharge readiness. METHODS: Sixty-four patients were randomly assigned to one of three treatment regimens. In group D, patients received 1 microg/kg dexmedetomidine over 15 min followed by an infusion of 0.2 microg x kg x h. Group P received meperidine (1 mg/kg) with midazolam (0.05 mg/kg), and group F received fentanyl (0.1-0.2 mg intravenous) on demand. The assessment included measurements of heart rate, blood pressure, oxygen saturation, respiratory rate, quality of sedation/analgesia, and an evaluation of the recovery time. RESULTS: The study was terminated before the planned 90 patients had been recruited because of adverse events in group D. In all groups, negligible hemoglobin oxygen saturation and respiratory rate variations were observed. In group D, there was a significantly larger decrease in heart rate (to approximately 40 beats/min in 2 of 19 cases) and blood pressure (to less than 50% of the initial value in 4 of 19 patients). Supplemental fentanyl was required in 47% of patients receiving dexmedetomidine to achieve a satisfactory level of analgesia (vs. 42.8% of patients in group P and 79.2% of patients in group F). Vertigo (5 patients), nausea/vomiting (5 patients), and ventricular bigeminy (1 patient) were observed only in group D. Time to home readiness was longest in group D (85 +/- 74, 39 +/- 21, and 32 +/- 13 min in groups D, P and F, respectively; P = 0.007). CONCLUSIONS: The use of dexmedetomidine to provide analgesia/sedation for colonoscopy is limited by distressing side effects, pronounced hemodynamic instability, prolonged recovery, and a complicated administration regimen.


Subject(s)
Conscious Sedation , Dexmedetomidine/pharmacology , Hypnotics and Sedatives/pharmacology , Adult , Aged , Ambulatory Care , Blood Pressure/drug effects , Colonoscopy , Female , Heart Rate/drug effects , Humans , Male , Middle Aged , Prospective Studies , Single-Blind Method
2.
Crit Care Med ; 32(10): 2021-8, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15483410

ABSTRACT

OBJECTIVE: The objectives of this study were to evaluate safety (primary) and clinical efficacy (secondary) of the humanized monoclonal anti-L-selectin antibody aselizumab in severely injured patients. DESIGN: Prospective phase II, parallel group, double-blind, randomized, placebo-controlled clinical trial. SETTING: Fourteen medical intensive care units or trauma units in level I trauma centers in Belgium, Germany, and Poland. PATIENTS: Eighty-four patients with a sustained trauma due to a blunt or penetrating injury and a total Injury Severity Scale score of > or =25. INTERVENTIONS: Patients received either aselizumab at dosages of 0.5, 1, or 2 mg/kg or placebo within 6 hrs of the traumatic event and were followed for 6 wks. MEASUREMENTS AND MAIN RESULTS: The number of expeditable adverse events increased dose dependently over the aselizumab groups compared with placebo. There were no statistically significant differences between all groups regarding leukopenia and risk of infection. No immunologic response following infusion of aselizumab was noted. The number of patients with multiple organ failure, defined as a median value of the total Goris Multiple Organ Failure score of > or =5 on > or =2 consecutive days within 14 days, was not significantly different for the 0.5 mg/kg, 1 mg/kg, 2 mg/kg, and placebo groups. There were no statistically significant differences in time of mechanical ventilation, length of stay in an intensive care unit, and total duration of hospitalization between treatment groups. CONCLUSIONS: Aselizumab was associated with a higher rate of infections and leucopenia; however, this difference was not significantly different compared with placebo. For all efficacy variables, aselizumab presented no significant trends but only a few scattered statistically significant differences between groups.


Subject(s)
Antibodies, Monoclonal/therapeutic use , L-Selectin/immunology , Multiple Organ Failure/immunology , Multiple Trauma/immunology , Adolescent , Adult , Aged , Antibodies, Monoclonal/immunology , Double-Blind Method , Female , Humans , Incidence , Male , Middle Aged , Multiple Organ Failure/epidemiology , Multiple Organ Failure/prevention & control , Multiple Trauma/complications , Prospective Studies , Treatment Outcome
3.
Resuscitation ; 61(3): 315-25, 2004 Jun.
Article in English | MEDLINE | ID: mdl-15172711

ABSTRACT

The purpose of this study was to evaluate the outcome of out-of-hospital cardiac arrest (CA) and cardiopulmonary resuscitation (CPR) in the city of Katowice, Poland, during a period of 1 year prior to the planned reorganization of the national emergency system. Data were collected prospectively according to a modified Utstein style. To ensure accurate data collection, a special method of reporting resuscitation events with the use of a tape-recorder was introduced. Patients were followed for a 1-year period. Between 1 July 2001 and 30 June 2002, out-of-hospital cardiac arrest was confirmed in 1153 patients. Cardiopulmonary resuscitation was attempted in 188 patients. Cardiac arrest of presumed cardiac aetiology (147) was bystander witnessed in 105 (71%) cases and lay-bystander basic life support was performed in 35 (24%). In the group of bystander witnessed arrest ventricular fibrillation (VF) or tachycardia was documented in 59, asystole in 40 and other non-perfusing rhythms in six patients. Of 147 patients with cardiac aetiology, return of spontaneous circulation (ROSC) was achieved in 64 (44%) patients, 15 (10%) were discharged alive and 9 (6%) were alive 1 year later. Most of these patients had a good neurological outcome. Time to first defibrillatory shock was significantly shorter for survivors (median 7 min) compared to non-survivors (median 10 min). The most important resuscitation and patient characteristics associated with survival were VF as initial rhythm, arrest witnessed, and lay-bystander CPR.


Subject(s)
Emergency Medical Services , Heart Arrest/mortality , Adolescent , Adult , Aged , Cardiopulmonary Resuscitation , Child , Child, Preschool , Female , Heart Arrest/therapy , Humans , Infant , Male , Middle Aged , Poland/epidemiology , Survival Rate , Time Factors
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