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Abstrak :
Latar belakang: Emergence agitation (EA) merupakan gangguan perilaku sementara yang sering terjadi pascaanestesia dengan sevoflurane dan berpotensi membahayakan pasien. Pemberian magnesium sulfat 10 % 20 mg/kg bolus IV selama 15 menit, dilanjutkan 10 mg/kg/jam secara infus kontinyu selama pembedahan diketahui mencegah EA. Penelitian ini bertujuan mengetahui efektivitas magnesium sulfat 10% 20 mg/kg bolus IV selama 10 menit pada 10 menit sebelum anestesia selesai dalam mencegah EA pada anak yang menjalani anestesia dengan sevoflurane. Magnesium sulfat dinilai efektif jika dapat menurunkan kejadian EA. Metode: Penelitian uji klinik acak tersamar ganda pada anak usia 1,5-12 tahun yang menjalani anestesia dengan sevoflurane di RSCM pada bulan September-Oktober 2018. Sebanyak 108 subjek didapatkan dengan metode konsekutif yang dirandomisasi menjadi dua kelompok. Kelompok Magnesium (n=54) mendapat magnesium sulfat 10% 20 mg/kg bolus IV selama 10 menit dengan pompa syringe pada 10 menit sebelum anestesia selesai, sedangkan kontrol (n=54) mendapat NaCl 0,9% 0,2 ml/kg bolus IV selama 10 menit dengan pompa syringe pada 10 menit sebelum anestesia selesai. Kejadian EA, waktu pulih, hipotensi pascaoperasi dicatat. EA dinilai dengan Pediatric Anesthesia Emergence Delirium (PAED). Analisis data menggunakan uji multivariat regresi logistik. Hasil: Kejadian EA pada kelompok magnesium sebesar 25,9% sedangkan kontrol 16,7% (OR = 0,786; IK 95% 0,296-2,091; p=0,63). Waktu pulih memiliki nilai rerata 8,2 + 4,74 menit untuk kelompok magnesium dibandingkan kontrol 10,87 + 6,799 menit (OR = 2,667; IK 95% 0,431-4,903; p=0,02). Pada kedua kelompok, tidak didapatkan kejadian hipotensi. Simpulan: Pemberian magnesium sulfat 10% 20 mg/kg bolus IV selama 10 menit pada 10 menit sebelum anestesia selesai secara statistik tidak efektif mencegah kejadian EA pada anak yang menjalani anestesia dengan sevoflurane.

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Background: Emergence agitation (EA) is a common transient behavioral disturbance after anesthesia with sevoflurane and may cause harm. Magnesium sulphate 10% 20 mg/kg as a slow intravenous bolus over 15 minutes, followed by 10 mg/kg/h as a continous intravenous infusion during surgery can prevent EA. This study evaluated the effectivity of magnesium sulphate 10% 20 mg/kg as a slow intravenous bolus over 10 minutes at 10 minutes before anesthesia ended to prevent the incidence of EA in children undergoing anesthesia with sevoflurane. Magnesium sulphate was considered effective if could reduce the incidence of EA. Method: This was a double-blind randomized clinical trial on children aged 1,5-12 years old underwent anesthesia with sevoflurane in RSCM on September until Oktober 2018. One hundred eight subjects were included using consecutive sampling method and randomized into two groups. Magnesium group (n=54) was given magnesium sulphate 10% 20 mg/kg as a slow intravenous bolus over 10 minutes at 10 minutes before anesthesia ended while control group (n=54) was given NaCl 0,9% 0,2 ml/kg as a slow intravenous bolus over 10 minutes at 10 minutes before anesthesia ended. Incidence of EA, recovery time and postoperative hypotension were observed. Pediatric Anesthesia Emergence Delirium (PAED) scale was used to assess EA. Statistical tests used were logistic regresssion multivariate analysis. Result: Incidence of EA in magnesium group was 25,9% while in control group was 16,7% (OR = 0,786; 95% CI 0,296-2,091; p=0,63). Mean recovery time in magnesium group was 8,2 ± 4,74 minutes and control group was 10,87 ± 6,799 minutes (OR = 2,667; 95% CI 0,431-4,903; p=0,02). Hypotension was not found in both groups. Conclusion: Administration of magnesium sulphate 10% 20 mg/kg as a slow intravenous bolus over 10 minutes at 10 minutes before anesthesia ended was not effective to prevent the incidence of EA in children undergoing anesthesia with sevoflurane.

Abstrak :
Latar belakang. Laparaskopi adalah tindakan invasif minimal yang walaupun diketahui tidak menyebabkan nyeri, namun masih dapat menyebabkan derajat nyeri sedang – berat pada periode awal pasca operasi. Magnesium sulfat (MgSO4) memiliki efek analgetik yang dapat mengurangi kebutuhan opioid dan mengurangi derajat nyeri pasca operasi. Namun penggunaan MgSO4 untuk manajemen nyeri belum umum digunakan karena kurangnya data mengenai dosis yang aman untuk menghasilkan efek analgesia yang adekuat, serta keamanannya. Penelitian ini bertujuan untuk mengetahui efek pemberian MgSO4 dalam menurunkan kebutuhan opioid intraoperatif serta derajat nyeri 24 jam pascaoperasi. Metode. Penelitian ini adalah uji klinis acak tersamar ganda yang melibatkan 50 pasien berusia 18-65 tahun yang menjalani operasi laparaskopi dalam anestesia umum. Pada kelompok perlakuan diberikan 50 mg/kgBB MgSO4 intravena 15 menit praoperasi dan dilanjutkan dosis rumatan 10 mg/kgBB/jam selama periode operasi. Kelompok kontrol dilakukan pemberian placebo menggunakan NaCl 0.9%. Hasil. Pada kelompok perlakuan maupun kontrol, tidak terdapat perbedaan bermakna dalam konsumsi opioid intraoperatif, dan pada derajat nyeri pascaoperasi. Keterbatasan pada penelitian ini antara lain adanya perbedaan durasi operasi yang cukup beragam dan perbedaan jenis operasi yang dapat merupakan faktor signifikan pada derajat nyeri pada populasi yang diikutsertakan dalam penelitian ini. Simpulan. Pemberian MgSO4 pada operasi laparaskopi tidak menurunkan jumlah konsumsi opioid intraoperatif maupun derajat nyeri pascaoperasi. Walaupun manfaat MgSO4 sangat bervariasi tergantung jenis operasi. ......Background. Laparascopy is a minimally invasive procedure that is known to produce minimal to no pain, however previous findings have shown that a moderate to severe pain is found during the early hours postoperatively. Magnesium sulphate (MgSO4) has an analgetic effect that may reduce opioid consumption and postoperative pain. However, usage of MgSO4 for pain management has not yet been applied to everyday practice due to the lack of data regarding the dosage to produce adequate analgetic effect, and its safety. This research is to understand the effect of MgSO4 to reduce intraoperative opioid consumption and 24 hours postoperative pain. Methods. This is a double blinded randomized clinical trial involving 50 patients aged 18-65 undergoing laparscopic surgery under general anesthesia. Treatment group is given a 50 mg/kgBB intravenous MgSO4 15 minutes preoperatively, followed by a maintenance dose of 10mg/kgBB/hour through the surgery. Control group is given a placebo using an NaCl 0.9%. Results. Findings have shown that there was no significant difference of intraoperative opioid consumption nor postoperartive pain within the treatment group and control group. Limitations of the study includes the variety of surgery duration and different types of surgery that is a significant factor in pain intensity. Conclusion. Application of MgSO4 did not cause reduction of intraoperative opioid consumption nor the postoperative pain. However, MgSO4 may be beneficial depending on the type of surgery in which it is applied to.

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ABSTRAK
Praktek Kerja Profesi Apoteker di PT Novell Pharmaceutical Laboratories dilaksanakan pada bulan Juli sampai September tahun 2016. Pelaksanaan praktek kerja profesi ini bertujuan untuk memahami peran serta tanggung jawab Apoteker di industri farmasi dan dalam proses pengembangan produk, khususnya di Departemen Business Development PT. Novell Pharmaceutical Laboratories. Proses pengembangan produk obat dan regulasi obat di industri farmasi harus sesuai dengan aturan pemerintah Indonesia. Tugas khusus diberikan berjudul penyusunan dokumen registrasi nonklinik dan klinik larutan injeksi magnesium sulfat sesuai kriteria dan tatalaksana registrasi obat oleh Badan Pengawas Obat dan Makanan BPOM . Tujuan penyusunan tugas khusus adalah untuk mengetahui tujuan dilakukan penyusunan dokumen klinik dan nonklinik serta memahami prosedur penyusunan dokumen klinik dan nonklinik injeksi magnesium sulfat sesuai dengan Kriteria dan Tatalaksana Registrasi Obat oleh BPOM.

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ABSTRACT
Pharmacists profession internship at PT Novell Pharmaceutical Laboratories was held on July to September 2016. Implementation of this internship aimed to understand the role and responsibilities of pharmacists in the pharmaceutical industry and the development of medicinal products, especially in Department of Business Development, PT. Novell Pharmaceutical Laboratories. The process of development of medicinal products in the pharmaceutical industry must be in accordance with the rules of the Indonesian government. Special task given to support the internship activities was entitled Preparation of Non Clinical and Clinical Registration Documents of Magnesium Sulfate Injection according to the drug registration criteria and procedure by drug and food supervisory agency BPOM . The purpose of the special task are to understand the purpose of composing clinic and nonclinical documents, as well as understand the procedure of clinical and nonclinical documents arrangement of magnesium sulfate injection in accordance with BPOM drug registration criteria and procedure.

Abstrak :
Pendahuluan. Angka kejadian POST dilaporkan dapat mencapai 60%. LMA masih memiliki kejadian POST hingga 26.3%. Berkumur dengan benzydamine hydrochloride terbukti efektif mengurangi POST, namun distribusinya di Indonesia belum merata. Kumur magnesium sulfat dapat dijadikan alternatif untuk mengurangi POST, harga dan distribusinya lebih merata. Penelitian ini bertujuan untuk membandingkan efektifitas kumur magnesium sulfat dengan benzydamine hydrochloride dalam mengurangi POST pascapemasangan LMA. Metode. Penelitian ini merupakan uji klinis acak tersamar tunggal. Sebanyak 164 subjek penelitian diambil secara consecutive sampling. Subjek penelitian mendapatkan botol penelitian yang berisikan obat kumur yang sudah dirandomisasi, dilanjutkan dengan prosedur anestesi. Setelah selesai operasi, pasien akan dinilai : kejadian nyeri tenggorok, derajat nyeri tenggorok, efek samping, odinofagia dan disfagia pada jam ke 2, 6, 24 dan 48 pascaoperasi. Hasil. Berdasarkan hasil penelitian, tidak didapatkan perbedaan bermakna antara kedua kelompok; pada kejadian nyeri tenggorok pasca-LMA di jam ke 2, 6 dan 24 dengan nilai P > 0.05 dan perbandingan derajat nyeri pasca-LMA kedua kelompok dengan nilai P > 0.05. Kejadian odinofagia kedua kelompok rendah dan hampir serupa. Tidak didapatkan efek samping dan kejadian disfagia pada penelitian ini. Simpulan. Kumur magnesium sulfat memiliki efektifitas yang tidak lebih buruk dibandingkan dengan kumur benzydamine hydrochloride dalam mengurangi kejadian nyeri tenggorok pascapemasangan LMA ......Introduction. The reported incidence of POST can reach 60%. LMA still has a POST incidence of up to 26.3%. Gargling with benzydamine hydrochloride has been proven to be effective in reducing POST, but its distribution in Indonesia is not evenly distributed. Magnesium sulfate gargle can be used as an alternative to reduce POST; its price and distribution are more even. This study aims to compare the effectiveness of magnesium sulfate gargle with benzydamine hydrochloride in reducing POST after LMA insertion. Method. This study was a single-blind, randomized clinical trial. A total of 164 research subjects were selected by consecutive sampling. Research subjects received research bottles containing randomized mouthwash, followed by an anesthesia procedure. After completion of the operation, the patient will be assessed for the incidence of throat pain, the degree of throat pain, side effects, odynophagia, and dysphagia at 2, 6, 24, and 48 hours after surgery. Results. Based on the research results, there were no significant differences between the two groups on the incidence of post-LMA throat pain at 2, 6, and 24 hours with a P value > 0.05 and a comparison of the degree of post-LMA pain between the two groups with a P value > 0.05. The incidence of odynophagia in both groups was low and almost similar. There were no side effects or incidences of dysphagia in this study. Conclusion. Magnesium sulfate gargle has no worse effectiveness than benzydamine hydrochloride gargle in reducing POST after LMA insertion.

Abstrak :
Dalam proses produksi feronikel dari bijih nikel laterit diperlukan energi yang besar. Metode reduksi selektif sedang dikembangkan untuk memproses bijih nikel laterit untuk menghasilkan kadar nikel yang tinggi dan efektif tanpa memerlukan energi yang besar. Pada penelitian ini telah dipelajari proses reduksi selektif bijih nikel laterit dangan kandungan alumina tinggi menggunakannatrium sulfat, kalsium sulfat, dan magnesium sulfat sebagai aditif dengan variasi dosis 5%, 10%, dan 15% berat. Batu bara antrasit digunakan sebagai reduktor pada penelitian ini sebanyak 5% berat. Reduksi dilakukan pada variasi temperatur 950, 1050, dan 1150^oC selama 60 menit. Proses separasi magnetik basah dengan kekuatan magnet 500 Gauss dilakukan pada tahapan setelah reduksi untuk memisahkan konsentrat (feronikel) yang bersifat magnetik dan tailing (pengotor) yang bersifat non-magnetik. Karakterisasi bijih laterit hasil reduksi dilakukan menggunakan X-ray Diffraction (XRD), mikroskop optik, dan Scanning Electron Microscope (SEM) yang dilengkapi Energy Dispersive X-ray Spectroscopy (EDS). Konsentrat dan tailing hasil separasi magnetik diidentifikasi menggunakan X-ray Fluororescene (XRF). Hasil penelitian ini menunjukkan bahwa kadar nikel optimum didapatkan pada temperatur reduksi 1150°C dengan nilai 0,702% untuk penambahan aditif natrium sulfat; 0,757% untuk penambahan aditif magnesium sulfat; dan 0,932% untuk penambahan aditif kalsium sulfat. penambahan masing-masing aditif sebesar 15% berat.

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In the process of producing ferronickel from laterite nickel ore, a large amount of energy is needed. Selective reduction methods are being developed to process laterite nickel ore to produce high and effective nickel content without requiring large amounts of energy. In this study, the selective reduction of nickel laterite containing high alumina content has been investigated by using sodium sulfate, calcium sulfate, and magnesium sulfate as additives with varying doses of 5%, 10%, and 15% wt. Anthracite coal was used as a reducing agent in this study by 5% weight. Reduction was conducted with variations in temperature of 950 ^oC, 1050 ^oC, dan 1150 ^oC for 60 minutes. Wet magnetic separation process with a magnetic strength of 500 Gauss is then carried out in the process after selective reduction to separate the magnetic concentrate (ferronickel) and the non-magnetic tailing (impurities). Characterization of the reduced ore laterite was performed using X-Ray Diffraction (XRD), optical microscopy, and Scanning Electron Microscope (SEM) equipped with Energy Dispersive X-ray Spectroscopy (EDS). The result of concentrate and tailing from magnetic separation were identified using X-ray Fluororescene (XRF). The results of this study indicate that the optimum nickel grade was obtained at a reduction temperature of 1150 °C with a value of 0.702% for the sodium sulfate additives; 0.757% for the magnesium sulfate additives; and 0.932% for the calcium sulfate additives withthe addition for each additive was 15% by weight.