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"Latar Belakang: Endoscopic Retrograde Cholangiopancreatography (ERCP) adalah tindakan endoskopi yang kompleks yang memerlukan sedasi. Sedasi dalam tindakan ini penting untuk imobilisasi pasien sehingga prosedur lebih mudah dilakukan. Propofol cukup ideal sebagai obat sedasi,obat ini disukai karena awitan yang cepat dan waktu pulih yang singkat. Hampir sebanyak 80% propofol berikatan dengan albumin. Kondisi hipoalbuminemia sendiri banyak ditemui pada pasien yang menjalani ERCP. Kondisi hipoalbuminemia dapat memengaruhi kadar propofol dan fentanil bebas dalam plasma. Perbedaan awitan dan waktu pulih pada pasien hipoalbuminemia yang menjalani ERCP dengan sedasi propofol-fentanil belum pernah diteliti.Metode: Penelitian ini adalah uji klinik Cross sectional, dilakukan secara tersamar. Pengumpulan subjek dilakukan secara consecutive sampling, masing-masing pasien diberikan sedasi dengan propofol kontinyu dosis 4ug/L, kemudian dilakukan pencatatan waktu hilangnya refleks bulu mata dan kembalinya kesadaran yang ditandai dengan kemampuan pasien mengikuti perintah menggenggam. Awitan dan waktu pulih kelompok pasien hipoalbuminemia dibandingkan dengan kelompok pasien kadar albumin normalHasil: Sebanyak 48 subjek diawal penelitian, 48 orang masuk kepada kriteria penerimaan. 48 subjek penelitian yang menjalani ERCP dengan sedasi kemudian dianalisis. Tidak terdapat perbedaan onset maupun waktu pulih antara kelompok hipoalbuminemia dan kadar albumin normal.Kesimpulan: Perbandingan awitan kelompok hipoalbuminemia dan kadar albumin normal tidak menunjukkan perbedaan, begitu juga dengan waktu pulih kelompok hipoalbuminemia dan kadar albumin normal.

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Background: Endoscopic Retrograde Cholangiopancreatography (ERCP) is a complex procedure that requires appropiate sedation. Propofol is considered as an ideal sedative with rapid onset and short recovery time. Almost 80% of propofol binds to albumin. Hypoalbuminemia, is a condition commonly found in patients undergoing ERCP, can affect the levels of free propofol and fentanyl in plasma. Differences in onset and recovery time in hypoalbuminemic patients undergoing ERCP with propofol-fentanyl sedation have not been studied.

Methods Similar number of hypoalbuminemic parients and patients with normal albumin level who underwent ERCP were collected consecutively. Each patient was given a dose of sedation with continuous propofol 4uG / L, then loss of eyelash reflex time and return of consciousness characterized by the ability of patients to follow the gripping command were recorded. The onset and recovery time of hypoalbuminemic patients were compared to patients with normal albumin levels.

Results A total of 48 subjects met the inclusion criteria. The median (range) onset of propofol in hypoalbuminemia group was 2 minutes (1 to 5 minutes), whereas normal albumin group was 3 minutes (1 to 4 minutes). The median (range) recovery time of propofol-fentanyl in hypoalbuminemia group was 10.5 minutes (6 to 17 minutes), while the normal albumin group was 11 minutes (8 to 20 minutes). The differences of onset and recovery time between two groups were not statistically significant (p=0,196 and p=0,422, respectively).

Conclusion: There were no differences in onset and time to recover of propofol and propofol-fentanyl in ERCP procedure between hypoalbuminemia group and normal albumin group."

"Latar Belakang: Sedasi yang efektif adalah terjaganya kedalaman sedasi dan analgesia serta mengendalikan pergerakan pasien selama prosedur ERCP berlangsung. Propofol merupakan obat anestetik sedasi yang tidak memiliki efek analgesia dan memiliki efek depresi kardiovaskular dan respirasi yang tergantung dosis. Penambahan ketamin dosis kecil diharapkan dapat menurunkan kebutuhan dosis propofol dalam mempertahankan kedalaman sedasi dan analgesia serta kestabilan hemodinamik dan respirasi. Penelitian ini akan membandingkan keefektifan sedasi antara campuran ketamin dan propofol (ketofol) konsentrasi 1:4, dan propofol - fentanil pada prosedur ERCP. Metode: Penelitian ini merupakan penelitian uji klinis acak tersamar ganda pada 36 pasien yang menjalani prosedur ERCP, dengan usia 18-60 tahun, ASA I-III, BMI 18-30 kg/m 2, yang dibagi menjadi dua kelompok yaitu kelompok KF (n=18) dan kelompok PF (n=18). Kedua kelompok obat menggunakan metode infus kontinyu dengan syringe pump. Kedalaman sedasi diukur dengan menggunakan Ramsay Sedation Scale (RSS). Hasil: Dari hasil penelitian didapatkan rerata konsumsi propofol permenit kelompok campuran ketamin propofol (ketofol) ( 93,71±11,82) lebih rendah bermakna secara statistik dibandingkan kelompok propofol fentanil (141,18±19,23) (p<0.05). Jumlah median kebutuhan fentanil pada kelompok ketofol ( 0,00(0-25)) lebih rendah bermakna dibandingkan kelompok propofol fentanil (25,00 (25-50)) (p<0.05). Mula kerja dan waktu pulih pada kelompok propofol fentanil (3,00(2-4)) dan (5,00(2-15)) lebih cepat dibandingkan kelompok ketofol (4,50(2-5)) dan (15,00 (5-20)) (p<0.05). Kejadian hipotensi pada kelompok ketofol 1,00 (5,56%) tidak berbeda bermakna secara statistik dengan kelompok propofol fentanil 3 (16,67%) (p=0,603). Tidak didapatkan kejadian desaturasi dan mual/muntah pada kedua kelompok. Kesimpulan: Campuran ketamin propofol (ketofol) efektif dalam menjaga kedalaman sedasi dan analgesia serta memiliki efek samping yang minimal.

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Background: The effectiveness of sedation is the ability of the drugs to maintain the depth of sedation and analgesia as well as to control the patient movement during the ERCP procedure. Propofol is a sedation agent that has no analgesia effect and has cardiovascular and respiratory depressant effect which is dose dependent. The addition of small dose of ketamin is expected to reduce the dose required to maintain hemodinamic and respiratory stability. This study will compare the effectiveness of sedation between the used of 1:4 of ketamin propofol mixtures (ketofol) and propofol fentanyl in ERCP procedure.

Methods: This study is a double blind randomised clinical trial in 36 patients who underwent ERCP procedure, aged 18-60 y.o, ASA I-III, BMI 18-30 kg / m2, which is divided into two groups: KF (n = 18) and the PF group (n = 18). Both group is using continuous syringe pump infusion. The depth of sedation was measured by using Ramsay Sedation Scale (RSS).

Results: From the results, the average consumption of propofol per minute of group propofol ketamine mixtures (ketofol) (93.71 ± 11.82) was significantly lower than fentanyl propofol group (141.18 ± 19.23) (p <0.05). The median fentanyl consumption of ketofol group (0.00 (0- 25)) was significantly lower than fentanyl propofol group (25.00 (25-50)) (p <0.05). The onset and the time to recover in fentanyl propofol group (3.00 (2-4)) and (5.00 (2-15)) were faster than ketofol group (4.50 (2-5)) and (15.00 (5-20)) (p <0.05). The incidence of hypotension in group ketofol 1.00 (5.56%) was not significantly different from fentanyl propofol group 3 (16.67%) (p = 0.603). There were no desaturation events or nausea/vomiting in both groups.

Conclusion: The mixture of ketamine propofol (ketofol) is effective in maintaining the depth of sedation and analgesia and has minimal side effects."

"LATAR BELAKANG: Sedasi dan analgesia yang baik diperlukan dalam prosedur Endoscopic Retrograde Cholangiopancreatography (ERCP). Spektrum terapeutik propofol sebagai agen sedatif pilihan yang sempit bila dikombinasikan dengan opioid seperti fentanyl menyebabkan angka kejadian efek samping akibat sedasi terutama desaturasi oksigen yang cukup tinggi. Penelitian ini bertujuan membandingkan efek ketamin (0,2 mg/kgBB) dengan fentanyl (1,5 mcg/kgBB) sebagai ajuvan propofol dalam mengurangi angka kejadian efek samping intrasedasi, serta mengetahui waktu discharge dan kebutuhan dosis propofol pada ERCP. METODE: 36 pasien ERCP dengan usia 18-65 tahun, IMT 18-30 kg/m2 dan status fisik ASA 1-3 dirandomisasi. Satu kelompok (18 pasien) mendapatkan bolus ketamin 0,2 mg/kgBB, kelompok lainnya (18 pasien) mendapatkan bolus fentanyl 1,5 mcg/kgBB. Kedua kelompok selanjutnya menggunakan TCI propofol rumusan Schneider dengan target konsentrasi efek (Ce). Target Ce dimulai dari 2 mcg/ml dinaikkan 1 mcg/ml setiap menitnya (Ce maksimal 4 mcg/ml) hingga tercapai nilai IOC 45-60 yang dipertahankan selama prosedur berlangsung. Dilakukan pencatatan ada tidaknya kejadian desaturasi oksigen dan hipotensi, serta kebutuhan dosis propofol selama prosedur dan waktu discharge. HASIL: Angka kejadian desaturasi oksigen pada kelompok ketamin-TCI propofol (11,1%) lebih rendah dibandingkan dengan kelompok fentanyl-TCI propofol (55,6%) dan secara statistik bermakna (p<0,05). Sementara tidak ditemukan perbedaan bermakna pada angka kejadian hipotensi, kebutuhan dosis propofol dan waktu discharge antara kedua kelompok perlakuan. SIMPULAN: Ketamin (0,2 mg/kgBB) lebih efektif dibandingkan dengan fentanyl (1,5 mcg/kgBB) dalam mengurangi angka kejadian efek samping intrasedasi terutama desaturasi oksigen pada prosedur ERCP.

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BACKGROUND: Appropriate sedation and analgesia are needed in Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. The narrow therapeutic spectrum of propofol as a sedative agent if combined with opioid such as fentanyl causes quite high intrasedation events especially oxygen desaturation. This study aims to compare the effect of ketamine (0,2 mg/kgBW) and fentanyl (1,5 mcg/kgBW) as an adjuvant of propofol in reducing intrasedation adverse events, also to measure discharge time and propofol dosage requirement in ERCP procedures.

METHODS: 36 patients undergoing ERCP aged 18-65 years old, BMI 18-30 kg/m2 and ASA physical status 1-3 were randomized. First group (18 patients) received ketamine bolus (0,2 mg/kgBW), second group (18 patients) received fentanyl bolus (1,5 mcg/kgBW). Propofol TCI was then initiated in both groups with Schneider pharmacokinetic model and targeted effect concentration (Ce). The initial effect concentration was 2 mcg/ml increased by 1 mcg/ml every minute (Ce maximum 4 mcg/ml) until IOC value between 45-60 which would be maintained during the procedure. Any oxygen desaturation and hypotension event, propofol dosage requirement and discharge time were recorded.

RESULTS: Oxygen desaturation event in ketamine-propofol TCI group (11.1%) was lower than fentanyl-propofol TCI group (55.6%) and this was statistically significant (p<0.05). While there were no significant differences in hypotension event, propofol dosage requirement and discharge time in both groups.

CONCLUSION: Ketamine (0,2 mg/kgBW) was more effective than fentanyl (1,5 mcg/kgBW) in reducing intrasedation adverse events especially oxygen desaturation in ERCP procedures."

"Latar belakang. Endoscopic retrograde cholangio pancreatography ERCP merupakan tindakan yang dapat menimbulkan rasa tidak nyaman dan nyeri pada pasien, sehingga diperlukan obat sedasi yang adekuat. Propofol dan ketamin adalah dua obat sedasi yang sering digunakan. Penambahan ketamin pada propofol dapat melawan efek depresi pernapasan dan kardiovaskular dari propofol. Kombinasi propofol dan ketamin ketofol telah digunakan sebagai obat sedasi pada berbagai prosedur medis. Namun, evaluasi efektivitas berbagai konsentrasi ketofol terkait perubahan hemodinamik, waktu pulih, dosis, dan efek samping belum banyak diteliti. Penelitian ini bertujuan untuk membandingkan efektivitas sedasi ketofol rasio 6:1 dengan rasio 4:1 pada ERCP.Metode. Penelitian ini merupakan uji klinis acak tersamar tunggal terhadap pasien yang menjalani ERCP di PESC RSCM pada bulan Maret-Mei 2017. Sebanyak 58 pasien diambil dan dirandomisasi menjadi dua kelompok. Kelompok K61 n=29 mendapat infus kombinasi propofol:ketamin 6:1, sedangkan kelompok K41 n=29 mendapat infus kombinasi propofol:ketamin 4:1. Kedalaman sedasi diukur menggunakan skor sedasi Ramsay. Analisis data menggunakan uji-t tidak berpasangan atau Mann-Whitney.Hasil. Rerata kebutuhan propofol antara ketofol 6:1 125,49 30,49 mcg/kg/mnt dan ketofol 4:1 121,28 28,94 mcg/kg/mnt tidak berbeda bermakna. Waktu pulih ketofol 6:1 6,55 0,5-19 mnt lebih cepat dibandingkan ketofol 4:1 11,37 4,9-20,53 mnt

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Background. Endoscopic retrograde cholangiopancreatography ERCP is a painful procedure that requires analgesic and sedative. Propofol and ketamine are common drugs that are used as sedative in ERCP. The addition of ketamine to propofol may counteract the cardiorespiratory depression caused by propofol. Ketofol, a combination of propofol and ketamine has been used as sedative in various medical procedures. However, evaluation of the effectiveness of different concentration of ketofol in procedural operation regarding changes in hemodynamic, recovery time, doses, and adverse effects was not yet studied. This study was conducted to compare the effectiveness of ketofol ratio of 6 1 with ratio of 4 1 in ERCP.

Methods. This was a randomized, single blinded study in patients underwent ERCP in PESC RSCM during March May 2017. There were 58 subjects who were randomized into two groups. K61 group n 29 received an infusion of ketofol ratio of 6 1, whereas K41 group n 29 received an infusion of ketofol ratio of 4 1. Sedation level was measured with Ramsay sedation score. Data were analyzed by t test or Mann Whitney test.Results. The average requirement of propofol between K61 125,49 30,49 mcg kg min and K41 121,28 28,94 mcg kg min was not significantly different. Recovery time of K61 6,55 0,5 19 min was faster compare to K41 11,37 4,9 20,53 min . There were no desaturation and emergence delirium recorded in both groups. Hypotension was recorded in one patient in each group. Hypersalivation only reported in one patient 3.4 in K61 group, whereas in K41 group there were five patients who were reported have hypersalivation. The incidence of nausea vomiting in K61 group was 6 20.7 and in K41 group was 11 37.9 . The level of postoperative pain in both groups was not significantly different.

Conclusion. Ketofol 6 1 was not more effective than ketofol 4 1 because the requirement of the drugs between both groups was not different, however ketofol 6 1 has faster recovery time and fewer adverse effects."

"Latar Belakang. Keganasan merupakan etiologi utama ikterus obstruktif selain batu. EUS memiliki nilai diagnostik yang lebih baik dibandingkan MRCP dalam mendeteksi batu saluran empedu. Di Indonesia, belum ada penelitian yang membandingkan EUS dan MRCP pada kasus keganasan saluran bilier dan pankreas. Nilai diagnostik ini penting untuk meningkatkan kecepatan dan ketepatan diagnostik sehingga dapat diambil tatalaksana yang paling sesuai.Tujuan. Mengetahui nilai sensitivitas dan spesifisitas EUS dibandingkan MRCP pada pasien ikterus obstruktif karena keganasan.Metode. Studi observasional analitik dengan mengumpulkan data rekam medik pasien usia > 18 tahun di RSCM yang terdiagnosis ikterus obstruktif diduga karena keganasan tahun 2014-2018 dan telah dilakukan pemeriksaan EUS dan atau MRCP sebelum dilakukan ERCP (baku emas). Dilakukan identifikasi hasil EUS, MRCP, dan ERCP, kemudian dilakukan analisis dengan IBM SPSS Statistic 20 untuk uji diagnostik.Hasil Utama. Terdapat 54 subyek yang memenuhi kriteria inklusi dan eksklusi, dimana 53,7% di antaranya adalah laki-laki dengan rerata usia 56,48 ± 11,37 tahun. Tumor kaput pankreas merupakan jenis keganasan yang paling banyak dijumpai (50%) berdasarkan pemeriksaan ERCP. Nilai sensitivitas, spesifistas, NDP, NDN, RKP, RKN, dan akurasi untuk EUS masing-masing adalah 96%, 60%, 96%, 60%, 2.40, 0.07, dan 93%. Untuk MRCP, nilai masing-masing adalah 90%, 40%, 94%, 29%, 1.50, 0.26, 85%. Sedangkan nilai AUC dari EUS adalah 78% (IK95% 51%-100%), p = 0,041. Untuk MRCP, nilai AUC yang diperoleh adalah 64,9% (IK95% 36,2%-93,6%), p = 0,276.Simpulan. EUS memiliki nilai sensitivitas dan spesifisitas yang lebih baik dibandingkan MRCP pada pasien ikterus obstuktif karena keganasan.

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Background Malignancy is the main etiology of obstructive jaundice besides stones. EUS has a better diagnostic value than MRCP in detecting bile duct stones. In Indonesia, there are no studies comparing EUS and MRCP in cases of biliary and pancreatic malignancies. This diagnostic value is important to improve the speed and accuracy of the diagnostic so that the most appropriate treatment can be taken.Methods Analytic observational study by collecting medical records of patients aged> 18 years in RSCM diagnosed with obstructive jaundice suspected due to malignancy in 2014-2018 and EUS and / or MRCP examination before the ERCP (gold standard) was performed. EUS, MRCP, and ERCP results were identified, then an analysis was performed with IBM SPSS Statistics 20 for diagnostic tests.Results There were 54 subjects who met the inclusion and exclusion criteria, of which 53.7% were men with an average age of 56.48 ± 11.37 years. Pancreatic head tumor is the most common type of malignancy (50%) based on ERCP examination. The sensitivity, specificity, PPV, NPV, LR+, LR-, and accuracy values for EUS are 96%, 60%, 96%, 60%, 2.40, 0.07, and 93%, respectively. For MRCP, the values are 90%, 40%, 94%, 29%, 1.50, 0.26, 85%, respectively. AUC value for EUS is 78% (CI95% 51%-100%), p = 0.041. Meanwhile, AUC value for MRCP is 64,9% (CI95% 36,2%-93,6%), p = 0.276.Conclusion: EUS has better sensitivity and specificity values than MRCP in obstructive jaundice patients due to malignancy."

"Latar Belakang : Pankreatitis pasca ERCP adalah komplikasi tersering dan menyebabkan peningkatan morbiditas dan mortalitas. Hidrasi agresif sebagai terapi pencegahan pankreatitis belum diteliti lebih lanjut.Tujuan : Mengetahui perbandingan efektivitas pencegahan pankreatitis pasca ERCP antara hidrasi agresif dengan hidrasi standar.Metode : Uji Klinis Acak tersamar ganda, satu sentral penelitian di Pusat Endoskopi Saluran Cerna (PESC) RS Cipto Mangunkusumo pada pasien usia antara 18-60 tahun yang menjalani tindakan ERCP periode Agustus-Oktober 2018. Randomisasi manual, Teknik sampling konsekutif dilakukan untuk mengalokasikan kelompok hidrasi agresif dan hidrasi standar. Pankreatitis ditegakkan dengan kriteria Atlanta.Hasil :  Didapatkan 92 pasien yang dirandomisasi kedalam dua kelompok. Didapatkan nilai Control Event Rate (CER) sebesar 15,2%, Experiment Event Rate (EER) sebesar 4,3% Absolute Risk Reduction (ARR) 10,9% Relative Risk (RR) 0,28 Relative Risk Reduction (RRR) 71,7% Number Needed to Treat (NNT) 9.  Tidak didapatkan efek samping pada kedua kelompok. Hidrasi agresif lebih efektif dalam mencegah pankreatitis pasca ERCP walaupun secara statistik tidak bermakna.  

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Pancreatitis post ERCP is a common complication and increased morbidity and mortality. Aggressive hydration as prevention of post ERCP pancreatitis has not been fully research.

Aims : To compare effectivity between aggressive hydration and standard hydration in preventing pancreatitis post ERCP.

Design and Methods : A double blind randomized clinical trial in one center at gastrointestinal endoscopy center RSCM was conducted on patients aged between 18-60 years old that had endoscopic retrograde cholangiopancreatography in the period from August to October 2018. Consecutive manual randomization was performed to allocate aggressive hydration and standard hydration. Pancreatitis diagnosed using Atlanta criteria.

Results : Two groups with total 92 subject was randomized equally. Analyzed resulted  Control Event Rate (CER) 15,2%, Experiment Event Rate (EER) 4,3%, Absolute Risk Reduction (ARR) 10,9%, Relative Risk (RR) 0,28, Relative Risk Reduction (RRR) 71,7%, Number Needed to Treat (NNT) 9.  No side effect reported in this trial. Aggressive hydration more effective in perventing post ERCP pancreatitis although statistically not significant.  "