Institutional review board (IRB) and ethical issues in clinical research

김원옥 대한마취통증의학회 2012 Korean Journal of Anesthesiology Vol.62 No.1

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.

Sufentanil 이 토끼의 심근 분리조직에 미치는 영향

김원옥,남순호,전성식 대한마취과학회 1996 Korean Journal of Anesthesiology Vol.30 No.1

Background: The synthetic narcotic sufentanil has been used in clinical practice for anesthetic induction and maintenance. But there is little information concerning its direct effects on heart. The purpose of this study is to evaluate the direct effects of sufentanil on contracture of ventricular myocardium. Methods: Isometric contraction of isolated right ventricular papillary muscle of rabbit was measured under 0.2 Hz electrical stimulation in Krebs solution. Peak developed force(Fo), maximum rate of rise of developed force(+dF/dt_(Max)), maximum rate of fall of developed force(-dF/dt_(Max)) were analyzed. Results: There were no statistically significant differences in frequency of isometric contraction from the 100% baseline value in time-matched control group. Sufentanil, in concentration of 0.01-0.1 mM, increased F, and -dF/dt_(max) was decreased especially in concentration of 0.1 mM but not +dF/dt_(Max) Fo +dF/dt_(max) and -dF/dt_(max) were statistically different from time-matched control group in concentration of 0.1 mM. Conclusions: We conclude that sufentanil has mild contracture effect on ventricular muscle of rabbit directly.

Efficacy and safety of a lidocaine/tetracaine medicated patch or peel for dermatologic procedures: a meta-analysis

김원옥,송병민,길혜금 대한마취통증의학회 2012 Korean Journal of Anesthesiology Vol.62 No.5

Background: To justify the use of the lidocaine/tetracaine medicated patch or peel as a preventive treatment for reducing pain and discomfort in adults and children. We reviewed randomized controlled trials (RCTs) to evaluate the efficacy and safety of the lidocaine/tetracaine medicated patch or peel compared with placebo. Methods: Ten RCTs (574 patients) were included in this systemic review. Relevant studies were identified through searches of MEDLINE, SCOPUS and the Cochrane database library. The outcome was the adequacy of cutaneous anesthesia reflected in the patient's assessment of pain intensity during minor dermatologic procedures and adverse effects after application of the lidocaine/tetracaine medicated patch or peel versus placebo. Results: The efficacy of the lidocaine/tetracaine patch or peel was consistently very significantly beneficial 30 or 60 minutes after the application compared to placebo (Relative risk, RR: 2.5; Number needed to treat, NNT: 2.2). We did not identify any difference in the effectiveness of adequate analgesia between the lidocaine/tetracaine patch and peel (the number needed to treat or to harm, NNT 2.4 vs. 2.0). No serious side effects or adverse events were observed with the lidocaine/tetracaine medicated patch or peel and placebo. Minor skin reactions were transient and resolved without treatment (Odd ratio, OR: 1.4 and 95% confidence interval, CI: 0.9-2.1; NNT: 14.9). Conclusions: The lidocaine/tetracaine medicated patch or peel is a well accepted, effective and safe method for minor dermatologic procedures based on pooled data of trials in terms of adequacy of cutaneous anesthesia and adverse effects. Background: To justify the use of the lidocaine/tetracaine medicated patch or peel as a preventive treatment for reducing pain and discomfort in adults and children. We reviewed randomized controlled trials (RCTs) to evaluate the efficacy and safety of the lidocaine/tetracaine medicated patch or peel compared with placebo. Methods: Ten RCTs (574 patients) were included in this systemic review. Relevant studies were identified through searches of MEDLINE, SCOPUS and the Cochrane database library. The outcome was the adequacy of cutaneous anesthesia reflected in the patient's assessment of pain intensity during minor dermatologic procedures and adverse effects after application of the lidocaine/tetracaine medicated patch or peel versus placebo. Results: The efficacy of the lidocaine/tetracaine patch or peel was consistently very significantly beneficial 30 or 60 minutes after the application compared to placebo (Relative risk, RR: 2.5; Number needed to treat, NNT: 2.2). We did not identify any difference in the effectiveness of adequate analgesia between the lidocaine/tetracaine patch and peel (the number needed to treat or to harm, NNT 2.4 vs. 2.0). No serious side effects or adverse events were observed with the lidocaine/tetracaine medicated patch or peel and placebo. Minor skin reactions were transient and resolved without treatment (Odd ratio, OR: 1.4 and 95% confidence interval, CI: 0.9-2.1; NNT: 14.9). Conclusions: The lidocaine/tetracaine medicated patch or peel is a well accepted, effective and safe method for minor dermatologic procedures based on pooled data of trials in terms of adequacy of cutaneous anesthesia and adverse effects.

산후 유방 마싸지 및 유즙압출이 충유 및 유즙분비에 미치는 영향

김원옥 한국간호과학회 1975 Journal of Korean Academy of Nursing Vol.5 No.2

마취과학 영역에서 전자계산기(Computer)의 응용

김원옥 대한마취과학회 1991 Korean Journal of Anesthesiology Vol.24 No.1

논문을 어떻게 쓸 것인가 ? : 대한마취과학회지를 중심으로

김원옥 대한마취과학회 1990 Korean Journal of Anesthesiology Vol.23 No.5

Humphrey Circuit System 의 임상적 관찰

김원옥,엄대자,최령 대한마취과학회 1986 Korean Journal of Anesthesiology Vol.19 No.4

The Humphrey circuit system functions with the efficiency of the Lack system for spontaneous respiration and of the Bain system for controlled ventilation. It is designed to incorporate into a single system the advantages of the Mapleson A, D and E type systems and to be available in coaxial and non-coaxial forms. This study was done to sudy the functions of a new anesthetic breathing system and to evaluate the adequacy of the recommended fresh gas flow. For spontaneous and controlled ventilation the system required a low fresh gas flow to achieve normocarbia(In the Lack circuit system, 60 ml/min., is useded and in the Bain circuit system, 70 ml/mn.). The advantage of this system was that it was simple to poerate and maintain, more easily sterilized and applicable in academic use. Further more the non-coaxial from of the circuit overcame the hazard of the inner tube complication. But this form was thought to have the provlem of humidifying the inspired gas which still has to be studied. This multicircuit system was used satisfactorily with low fresh gas flow under spontaneous and controlled ventilation maintaining normal range of arterial carbon dioxide. It may become one of the preferred semiclosed breathing systems because of simplicity, multipurpose usefulness and other advantages.

중환자실 환자의 임상통계 고찰

김원옥,이현우,엄대자,최령 대한마취과학회 1986 Korean Journal of Anesthesiology Vol.19 No.3

The intensive care unit (ICU) of our hospital is a 12 bed multidisciplinary ICU which is under the auspices of the Department of Anesthesiology. The ICU is essentially a respiratory ICU in which all hospital patients requiring ventilatory support are cared for. The patient population encompasses all causes of respiratory failure, medical and surgical. Another source of referral (surgical and medical) is a large group of critically ill patients with multiorgan failure, especially due to trauma. Our experience of intensive care therapy began in the recovery room starting in 1959. Since that time the size and facilities of the ICU have been enlarged. We analyzed 4,514 ICU patients admitted between Mar. 1980 and Feb. 1984, to obtain better guidance and management in the ICU. The results of analysis are as follows: 1) Total number of patients was 4,514; 874 patients in 1980, 832 patients in 1981, 895 patients in 1982, 862 patients in 1983 and 1,051 patients in 1984. The ratio of male to female patients was nearly 2:1. 2) Total admission time in the ICU was 17,473 days. The average patient stay was 3.9 days. The number of patients staying in the ICU more than 9 days increased from 54 cases(6%) in 1980 to 101 cases(10%) in 1984. 3) The forty year age group outrumbered the order age group and was 20.5%. The mortality rate of the pre-teen age group was the highest(19.7%) and the overall mortality was 14.2%(640 cases) during these 5 years. 4) The number of patients admitted to the ICU from the Department of Neurosurgery was 1,218 (27%)being the highest among all departments. Out of 232 patients who died, the Department of Neurosurgery had the highest mortality rate, 19.1%. Form the above results, it can be seen that the number of patients admitted to the ICU., the mortality rate and the patients staying more than 9 days in the ICU has increased annually It is claimed that more facilities allowing for monitoring and support, special qualified staffs and a co-ordinated organization will reduce the mortality rate, particularly in the pre-teen age group.

Clinical Effects of Discontinuing 5-Alpha Reductase Inhibitor in Patients With Benign Prostatic Hyperplasia

김원옥,정재흥,강태욱,송재만,정현철 대한비뇨의학회 2014 Investigative and Clinical Urology Vol.55 No.1

Purpose: To assess changes in lower urinary tract symptoms (LUTS), prostate volume,and serum prostate-specific antigen (PSA) after discontinuation of 5-alpha reductaseinhibitor (5ARI) combination therapy in patients with benign prostatic hyperplasia(BPH). Materials and Methods: From December 2003 to December 2012, data were collectedretrospectively from 81 men more than 40 years of age with moderate to severe BPHsymptoms (International Prostate Symptom Score [IPSS]≥8). The men were classifiedinto group 1 (n=42) and group 2 (n=39) according to the use of 5ARI therapy. A combinationof dutasteride 0.5 mg with tamsulosin 0.2 mg was given daily to all patients for1 year. For the next 1 year, group 1 (n=42) received the combination therapy and group2 (n=39) received tamsulosin 0.2 mg monotherapy only. The IPSS, prostate volume,and PSA level were measured at baseline and at 12 and 24 months according to theuse of dutasteride. Results: Discontinuation of dutasteride led to significant deterioration of LUTS, increasedprostate volume, and increased PSA level. The repeated-measures analysis ofvariance showed that the changes in IPSS, prostate volume, and PSA level over timealso differed significantly between groups 1 and 2 (p<0.001). Conclusions: Withdrawal of 5ARI during combination therapy resulted in prostate regrowthand deterioration of LUTS. The PSA level is also affected by the use of 5ARI. Therefore, regular check-up of the IPSS and PSA level may be helpful for all patientswho either continue or discontinue the use of 5ARI.

심전도 전극에 의한 화상

김원옥,강정완,이성진 대한마취과학회 1998 Korean Journal of Anesthesiology Vol.34 No.2

Electrosurgery can pose some risk to patients. Recently we experienced a case of accidental burning. Nine year-old patient received burn at the site of the ECG electrode attached to the right subclavian area during an electrosurgical operation. Even though the cutting and coagulation powers were not so much high, inappropriate earth with the fault of electrosurgical unit might lead to the generation of heat. To avoid recurrence, every electrical instruments should inspected, tested and required to be fault-free. Properly functioning surgical and monitoring units must be used. (Korean J Anesthesiol 1998; 34: 461∼463)