• Title/Summary/Keyword: patient safety

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Evaluation of safety by skin dosimetry in Intraoperative Radiotherapy for breast cancer patients (유방암 환자의 수술 중 방사선치료 시 피부선량 측정을 통한 안전성 평가)

  • Jung, In Ho;Kim, Joon Won;Park, Kwang Woo;Ha, Jin Sook;Jeon, Mi Jin;Cho, Yoon Jin;Kim, Sei Joon;Kim, Jong Dae;Shin, Dong Bong
    • The Journal of Korean Society for Radiation Therapy
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    • v.27 no.1
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    • pp.13-22
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    • 2015
  • Purpose : We investigated the safety of Intrabeam$^{TM}$ system, X-ray unit for Intraoperative Radiotheray (IORT) by measuring surface dose using Optically Stimulated Luminescent Dosimeter(OSLD). Materials and Methods : 30 patients were selected, who were in breast cancer patients and had an operation of breast conserving surgery (BCS). At the inner surface of tumor bed, 20 Gy were described, and 5 Gy at 1cm depth from the inner surface. Along the size of tumor bed which could be decided after resection of tumor, the size of applicator were determined. Usual treatment time were from 18 to 40 minutes. For the measurement of surface doses, OSLD were placed at superior(U1,2), inferior(D1,2), lateral(L1,2) and medial(M1,2) directions from the center of applicator. Each direction, two OSLD were placed at 0.5 cm and 1.5 cm from the center. Mean, maximum, and minimum doses were analyzed to be compared. Results : Mean values were U1 $2.23{\pm}0.80Gy$, U2 $1.54{\pm}0.53Gy$, D1 $1.73{\pm}0.63Gy$, D2 $1.25{\pm}0.45Gy$, L1 $1.95{\pm}0.82Gy$, L2 $1.38{\pm}0.42Gy$, M1 $2.03{\pm}0.70Gy$, and M2 $1.51{\pm}0.58Gy$. Maximum values were 4.34 Gy at U1, and Minimum values were 0.45 Gy at M2. 13.3 % of patient (4pts out of 30) were reported that surface dose were over 4 Gy. Conclusion : The fact that skin dose of all patients were less than 5 Gy based on OSLD measurement showed the safety of Intrabeam$^{TM}$ system. In the relatively small breast volume, the tendency that surface dose was increased had been shown, which was analyzed by the data of patients who irradiated over 4Gy at skin surface. Therefore, for appropriate indication for IORT, it is suggested that breast volume as well as the size and position of tumor should be carfully considered.

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Clinical efficacy and safety of lamotrigine monotherapy in newly diagnosed pediatric patients with epilepsy (간질 환아에서 Lamotrigine 초기 단독 요법의 효능 및 안정성에 대한 연구)

  • Han, Ji-Hye;Oh, Jung-Eun;Kim, Sun-Jun
    • Clinical and Experimental Pediatrics
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    • v.53 no.4
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    • pp.565-570
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    • 2010
  • Purpose : To verify the efficacy and safety of lamotrigine (LTG) monotherapy in newly diagnosed children with epilepsy. Methods : We prospectively enrolled 148 children who had undergone LTG monotherapy at our institution between September 2002 and June 2009. Twenty-nine patients were excluded: 19 due to incomplete data and 10 were lost to follow up. The data of the remaining 119 patients was analyzed. Results : We enrolled 119 pediatric epilepsy patients (aged 2.8-19.3 years; 66 males and 53 females) in this study. Out of 119 patients, 29 (25.2%) had generalized epilepsy and 90 (74.8%) had partial epilepsy. The responses of seizure reduction were as follows: Seizure freedom (no seizure attack for at least 6 months) in 87/111 (78.4%, n=111) patients; partial response (reduced seizure frequency compared to baseline) in 13 (11.7%) patients; and persistent seizure in 11 (9.9%) patients. The seizure freedom rate was in 81.6% in patients with partial seizure (75.9% for complex partial seizure and 90.9% for benign rolandic epilepsy) and 44.8% in patients with generalized epilepsy (30.0% for absence seizure, 35.7% for juvenile myoclonic epilepsy patients, and 100.0% for idiopathic generalized epilepsy patients). Adverse reactions were reported in 17 (14.3%) patients, and 8 patients (6.7%) discontinued LTG because of rash and tic. No patient experienced severe adverse reaction such as Stevens-Johnson syndrome. Conclusion : LTG showed excellent therapeutic response and had few significant adverse effects. Our findings report may contribute in promoting the use of LTG monotherapy in epileptic children.

A Phase I/II Trial of $DCVac/IR^{(R)}$ Dendritic Cell Immunotherapy Combined with Irradiation in Cases of Refractory Colorectal Cancer with Multiple Liver Metastases (기존의 치료에 반응하지 않는 다발성 간전이 대장암 환자에서 방사선조사와 병합한 수지상세포 면역치료의 1, 2상 임상시험)

  • Choi, Young-Min;Lee, Hyung-Sik;Kwon, Hyuk-Chan;Han, Sang-Young;Choi, Jong-Cheol;Chung, Ju-Seop;Kim, Chang-Won;Kim, Dong-Won;Kang, Chi-Duk
    • Radiation Oncology Journal
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    • v.26 no.2
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    • pp.104-112
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    • 2008
  • Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.

Preliminary Results of Concurrent Chemotherapy and Radiation Therapy using High-dose-rate Brachytherapy for Cervical Cancer (자궁경부암에 항암화학요법과 동시 병용요법으로 외부 방사선조사와 고선량률 강내조사의 예비적 치료 결과)

  • Lee, Kyung-Ja;Lee, Ji-Hye;Lee, Re-Na;Suh, Hyun-Suk
    • Radiation Oncology Journal
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    • v.24 no.3
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    • pp.171-178
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    • 2006
  • [ $\underline{Purpose}$ ]: To determine the efficacy and safety of concurrent chemotherapy and radiation therapy with high-dose-rate brachytherapy for cervical cancer. $\underline{Materials\;and\;Methods}$: From January 2001 to December 2002, 30 patients with cervical cancer were treated with concurrent chemotherapy (cisplatin and 5-FU) and definitive radiation therapy. The median age was 58 (range $34{\sim}74$) year old. The pathology of the biopsy sections was squamous cell carcinoma in 29 patients and one was adenocarcinoma. The distribution to FIGO staging system was as follows: stage IB, 7 (23%); IIA, 3 (10%); IIB, 12 (40%); IIIA, 3 (10%); IIIB, 5 (17%). All patients received pelvic external beam irradiation (EBRT) to a total dose of $45{\sim}50.4\;Gy$ (median: 50.4 Gy) over $5{\sim}5.5$ weeks. Ir-192 HDR intracavitary brachytherapy (ICBT) was given after a total dose of 41.4 Gy. HDR-ICBT was performed twice a week, with a fraction point A dose of 4 Gy and median dose to point A was 28 Gy (range: $16{\sim}32\;Gy$) in 7 fractions. The median cumulative biologic effective dose (BED) at point A (EBRT+ICBT) was $88\;Gy_{10}$ (range: $77{\sim}94\;Gy_{10}$). The median cumulative BED at ICRU 38 reference point (EBRT+ICBT) was $131\;Gy_3$ (range: $122{\sim}140\;Gy_3$) at point A, $109\;Gy_3$ (range: $88{\sim}125\;Gy_3$) at the rectum and $111\;Gy_3$ (range: $91{\sim}123\;Gy_3$) at the urinary bladder. Cisplatin ($60\;mg/m^2$) and 5-FU ($1,000\;mg/m^2$) was administered intravenously at 3 weeks interval from the first day of radiation for median 5 (range: $2{\sim}6$) cycles. The assessment was performed at 1 month after completion of radiation therapy by clinical examination and CT scan. The median follow-up time was 36 months (range: $8{\sim}50$ months). $\underline{: The complete response rate after concurrent chemoradiation therapy was 93.3%. The 3-yr actuarial pelvic control rate was 87% and 3-yr actuarial overall survival and disease-free survival rate was 93% and 87%, respectively. The local failure rate was 13% and distant metastatic rate was 3.3%. The crude rate of minor hematologic complications (RTOG grade 1-2) occurred in 3 patients (10%) and one patient had suffered from severe leukopenia (RTOG grade 4) during concurrent treatment. Acute minor enterocolitis (RTOG grade 1-2) occurred in 11 patients (37%) and one patient (3%) was suffered from colon perforation during radiation therapy. Late colitis of RTOG grade 1 occurred in 5 patients (15%). Acute cystitis of RTOG grade 1 occurred in 12 patients (40%) and late cystitis of RTOG grade 2 occurred in one patient (3%). No treatment related death was seen. $\underline{Conclusion}$: The results of this study suggest that the concurrent chemoradiation therapy with HDR brachytherapy could be accepted as an effective and safe treatment for cervical cancer.

The first private-hospital based proton therapy center in Korea; status of the Proton Therapy Center at Samsung Medical Center

  • Chung, Kwangzoo;Han, Youngyih;Kim, Jinsung;Ahn, Sung Hwan;Ju, Sang Gyu;Jung, Sang Hoon;Chung, Yoonsun;Cho, Sungkoo;Jo, Kwanghyun;Shin, Eun Hyuk;Hong, Chae-Seon;Shin, Jung Suk;Park, Seyjoon;Kim, Dae-Hyun;Kim, Hye Young;Lee, Boram;Shibagaki, Gantaro;Nonaka, Hideki;Sasai, Kenzo;Koyabu, Yukio;Choi, Changhoon;Huh, Seung Jae;Ahn, Yong Chan;Pyo, Hong Ryull;Lim, Do Hoon;Park, Hee Chul;Park, Won;Oh, Dong Ryul;Noh, Jae Myung;Yu, Jeong Il;Song, Sanghyuk;Lee, Ji Eun;Lee, Bomi;Choi, Doo Ho
    • Radiation Oncology Journal
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    • v.33 no.4
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    • pp.337-343
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    • 2015
  • Purpose: The purpose of this report is to describe the proton therapy system at Samsung Medical Center (SMC-PTS) including the proton beam generator, irradiation system, patient positioning system, patient position verification system, respiratory gating system, and operating and safety control system, and review the current status of the SMC-PTS. Materials and Methods: The SMC-PTS has a cyclotron (230 MeV) and two treatment rooms: one treatment room is equipped with a multi-purpose nozzle and the other treatment room is equipped with a dedicated pencil beam scanning nozzle. The proton beam generator including the cyclotron and the energy selection system can lower the energy of protons down to 70 MeV from the maximum 230 MeV. Results: The multi-purpose nozzle can deliver both wobbling proton beam and active scanning proton beam, and a multi-leaf collimator has been installed in the downstream of the nozzle. The dedicated scanning nozzle can deliver active scanning proton beam with a helium gas filled pipe minimizing unnecessary interactions with the air in the beam path. The equipment was provided by Sumitomo Heavy Industries Ltd., RayStation from RaySearch Laboratories AB is the selected treatment planning system, and data management will be handled by the MOSAIQ system from Elekta AB. Conclusion: The SMC-PTS located in Seoul, Korea, is scheduled to begin treating cancer patients in 2015.

Implementation of Man-made Tongue Immobilization Devices in Treating Head and Neck Cancer Patients (두 경부 암 환자의 방사선치료 시 자체 제작한 고정 기구 유용성의 고찰)

  • Baek, Jong-Geal;Kim, Joo-Ho;Lee, Sang-Kyu;Lee, Won-Joo;Yoon, Jong-Won;Cho, Jeong-Hee
    • The Journal of Korean Society for Radiation Therapy
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    • v.20 no.1
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    • pp.1-9
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    • 2008
  • Purpose: For head and neck cancer patients treated with radiation therapy, proper immobilization of intra-oral structures is crucial in reproducing treatment positions and optimizing dose distribution. We produced a man-made tongue immobilization device for each patient subjected to this study. Reproducibility of treatment positions and dose distributions at air-and-tissue interface were compared using man-made tongue immobilization devices and conventional tongue-bites. Materials and Methods: Dental alginate and putty were used in producing man-made tongue immobilization devices. In order to evaluate reproducibility of treatment positions, all patients were CT-simulated, and linac-gram was repeated 5 times with each patient in the treatment position. An acrylic phantom was devised in order to evaluate safety of man-made tongue immobilization devices. Air, water, alginate and putty were placed in the phantom and dose distributions at air-and-tissue interface were calculated using Pinnacle (version 7.6c, Phillips, USA) and measured with EBT film. Two different field sizes (3$\times$3 cm and 5$\times$5 cm) were used for comparison. Results: Evaluation of linac grams showed reproducibility of a treatment position was 4 times more accurate with man-made tongue immobilization devices compared with conventional tongue bites. Patients felt more comfortable using customized tongue immobilization devices during radiation treatment. Air-and-tissue interface dose distributions calculated using Pinnacle were 7.78% and 0.56% for 3$\times$3 cm field and 5$\times$5 cm field respectively. Dose distributions measured with EBT (international specialty products, USA) film were 36.5% and 11.8% for 3$\times$3 cm field and 5$\times$5 cm field respectively. Values from EBT film were higher. Conclusion: Using man-made tongue immobilization devices made of dental alginate and putty in treatment of head and neck cancer patients showed higher reproducibility of treatment position compared with using conventional mouth pieces. Man-made immobilization devices can help optimizing air-and-tissue interface dose distributions and compensating limited accuracy of radiotherapy planning systems in calculating air-tissue interface dose distributions.

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Complete Myocardial Revascularization Utilizing Parallel Secluential Anastomoses (Parallel sequential anastomosis를 이용한 관상동맥 우회수술의 성적)

  • 박계현;김관민
    • Journal of Chest Surgery
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    • v.30 no.7
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    • pp.647-655
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    • 1997
  • We evaluated the feasibility and safety of this method by reviewing the early outcome of the patients who underwent coronary artery bypass grafting(CABG) utili ing parallel sequential anastomoses with saphenous vein grafts, comparing with the outcome of the patients revascularized with grafts having only single distal anastomosis. During the one-year period of 1995, a total of 79 patients underwent isolated CABG, among whom 39 patients with sequential vein grafts(sequential group) and 40 patients without sequential grafts(non-sequential group). There was no difference between the two groups in terms of preoperative status, except in the extent of the coronary disease; 87.2% of the sequential group and 45.0% of the non-sequential group had left main andlor triple vessel involvement. 318 distal coronary anastomoses were done; 198 for the sequential group(5.1/patient) and 120 for the non-sequential group(3.0/patient). In the sequential group, the mean durations of cardiopulmonary bypass and aortic clamp per one distal anastomosis were 33.5 and 21.1 minutes, respectively. In the non-sequential group, these were 41.8 and 22.7 minutes. There were two operative deaths, both in the non-sequential group. There was no difference in the incidence of postoperative complications including myocardial infarction. During the follow-up period(2 to 15 months), 8 patients(3 in the sequential and 5 in the nonsequential group) complained of residual or recurrent angina. Comparison of preoperative and postoperative ."'Thallium myocardial perfusion scans in 30 patients showed improved or normal perfusion reserve in 83.3% of segments bypassed with sequential grafts and 82.5% of segments bypassed with non-sequential graft(5), These results show that, utilizing parallel sequential anastomoses with saphenous vein grafts, we could achieve satisfactory short-term clinical results in patients with extensive coronary stenoses. So, we conclude that this technique is a safe, technically feasible strategy for CABG, which can achieve the aim of complete myocardial revascularization with a limited length of graft.raft.

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Review of 2014 Major Medical Decisions (2014년 주요 의료판결 분석)

  • Jeong, Hye Seung;Lee, Dong Pil;Yoo, Hyun Jung;Lee, Jung Sun
    • The Korean Society of Law and Medicine
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    • v.16 no.1
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    • pp.155-190
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    • 2015
  • The court sentenced meaningful decisions related to the medical service in 2014. The court assumed the negligence of medical staff in the accident if being broken while using the medical equipment for not an original purpose at the time of surgery and ruled that the compensation for damage can be recognized in recognition of the causal relationship between the explanation duty violation and side effect's happening when unproven surgery on safety is implemented regarding the duty of explanation, that in the case of cosmetic surgery, the subject on the duty of explanation needs to be expanded compared to the general medical practice and that the duty of explanation cannot be accepted for the range that cannot be expectable. Also, the court has provided the requirement and limitation of self-determination exercise in case of the crash between patient's self-determination and doctor's duty of care and has ruled that as automobile insurance contract is a contract with the insurance company to pay regarding liability for car accidents, treating patients and taking the insurance money is not illegal activity even for the unlicensed hospital violating the medical law while established. The judgment stating the opinion that medical practitioners cannot be punished according to the medical law prohibiting the receiving of rebate in case that medical practitioners did not receive benefit while the medical institution itself gained an unfair economic benefit also stands out. And the court has ruled that even if the medical institution who received a business suspension is closed, the suspension is still effective in case that the same operator opens a new medical institution in the same place, ruled on the requirement to conduct a medical service outside of the medical institution that the doctor opened and ruled that the administrative penalty cannot be conducted prior to the conviction on charge of violating the medical law.

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Improvement of Patient Safety and Inspection Satisfaction by Developing Pretreatment Process System with the Patients Who Reserved CT Enhance Examination (CT 조영검사 예약환자의 전처치 프로세스 시스템 개발을 통한 환자안전 및 검사 만족도 향상)

  • Beom, Hyinam;Han, Jaebok;Song, Jongnam;Kim, Wook;Choi, Namgil
    • Journal of the Korean Society of Radiology
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    • v.10 no.1
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    • pp.29-37
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    • 2016
  • This study aims to improve the satisfaction level of the patient who undergoes CT contrast examination by developing and applying pretreatment process system, which not only can reduce the side effects caused by the test but also can help carry out the test smoothly. The subjects were 214 patients who booked CT contrast examination from January 2014 to February 2014 but could not carry out their test on schedule. We analyzed the reasons for the delay and conducted follow-up survey on them. We analyzed the usefulness of pretreatment process system by contemplating and developing pretreatment process system and applying it to the patients for whom follow-up survey was conducted from January 2015 to February 2015. The number of outpatients who came to the hospital form January to February 2014 was 2,846 and the number of patients who could not undergo the test was 214, accounting for 7.52% of the total. The specific reason for the delay includes 214 cases of unknown creatinine 98 with 120 minutes of average delay time, 40 cases of creatinine over 1.3(19%) with 30minutes of average delay time, 34 cases of past contrast media side effect 6% with 40 minutes of average delay time and 25 cases of lack of pretreatment such as fasting, etc. 11% with 120minutes of average delay time. The number of CT scan has been increasing ever since the development of CT and the frequency of using the contrast media is expected to increase. If we can employ pretreatment process system in order to effectively control the side effect of contrast media and help the CT contrast examination to be smoothly conducted on schedule, I'm sure we could improve the quality of our medical service and increase our patients' satisfaction who come to our CT scan room.

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.