• Title/Summary/Keyword: Therapeutic Drug Monitoring

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Acoustic outputs from clinical extracorporeal shock wave lithotripsy devices (임상에서 사용중인 체외충격파쇄석기의 음향 출력 분포)

  • Jong Min Kim;Oh Bin Kwon;Jin Sik Cho;Sung Joung Jeon;Ki Il Nam;Sung Yong Cho;Min Joo Choi
    • The Journal of the Acoustical Society of Korea
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    • v.42 no.5
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    • pp.469-490
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    • 2023
  • Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

The Effect of Midazolam As Sedative Agent in Bronchoscopy (기관지내시경 검사시 전처치로서 Midazolam의 효과)

  • Lee, Sang-Haak;Hyun, Dae-Sing;Lee, Sook-Young;Kim, Seok-Chan;Kim, Young-Kyoon;Kim, Kwan-Hyoung;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.6
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    • pp.612-618
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    • 2002
  • Background : Bronchoscopy is an important diagnostic and a therapeutic tool in chest medicine. However, most patients feel that a bronchoscopy is an unpleasant procedure, and it is important to sedate the patients appropriately, particularly where repetitive examinations are required. Midazolam is a sedative drug with amnestic qualities and a rapid 2 hour half-life. This study have attempted to determine the safety, appropriate dosage, and the effect of midazolam premedication in patients who underwent a bronchoscopy. Methods : One hundred and eighty consecutive patients undergoing bronchoscopy were enrolled in this study. The patients received a midzolam doses of 0.03 mg/kg, 0.06 mg/kg, or a placebo. An additional dose of lidocaine, the total number of coughs, and the duration of the procedures were recorded with monitoring the the blood pressure, heart rate, and oxygen saturation. The level of satisfaction was assessed by the patient, bronchoscopist, and the nurse. Results : The blood pressure, pulse rates, oxygen saturation, number of coughs, lidocaine dose, and procedure time in the 3 groups were similar. There was a trend for the midazolam 0.03 mg/kg group to satisfy bronchoscopists more than the other two groups. The nurses' acceptability was lower in the midazolam 0.06 mg/kg group than the other groups. The patients' acceptablity was greater in both the midazolam 0.03 mg/kg and 0.06 mg/kg groups than in the control group. Conclusion : Sedation with low doses of intravenous midazolam is a safe technique for fiberoptic bronchoscopy with a low morbidity and high acceptable to patients and bronchoscopists.