Perbandingan Ukuran Droplet Emulsi Propofol 200 mg yang Dicampur dengan Lidokain 10 mg pada Suhu yang Berbeda 6 Jam Setelah Pencampuran

Background. Propofol (2,6-diisopropylphenol) has gained popularity as an anesthetic agent both for induction and maintenance of anesthesia. Propofol is formulated as a lipid macroemulsion containing soybean oil (100 mg/ml), lecithin (12 mg/ml), and glycerol (22,5 mg/ml). Pain on injection of propofol is a common problem. Lidocaine has been frequently addedto propofol emulsion for alleviating pain on injection. Macroemulsion propofol thermodynamically unstable and degrades over time. Mixture of aquaous lidocaine with propofol emulsion leads to such instability, physically the droplet size enlargment.Enlargement of propofol droplet sizedecrease the release rate of propofol and propofol concentrations but increase the risk for fat embolism. Risk for fat embolism increased when droplet size exceeds the percentage of fat globule >5 m (PFAT5)population>0.05%. In clinical practice we used propofol lidocaine mixture frequently to reduce propofol induced pain. That`s mixture sometimes was stored in the refrigerator or at room temperature for further usage.The purpose of this study is to compare mean droplet size propofol 200 mg-lidocaine 10 mg mixture after storage procedure for 3housr and 6 hours in the different temperature.

Methods. This was a controlled trial study to compared Mean Droplet Size (MDS) of propofol 200 mg- lidocaine 10 mg mixture after storage procedure in refrigerator (2-4)0 C and at room temperature (19-24)0 C at 3hours and 6hours. There were 12 samples in each group. The droplet size was determined using microscope monitor. Measurement of droplet size was done manually. In each samples we measured 500 droplets. Data were analyzed by independent t test for the normal distribution and Man Whitney test for non normal ditribution. A value of p < 0.05 was considered to be statistically significant.

Result.There was a difference MDS between propofol 200 mg-lidocaine 10 mg mixture that was stored in refrigerator (1.99±0.45) with at room temperature (2.18±0,67) at 3 hours, statistically significant (p<0.05), and that was stored in refrigerator (2,84±0.93) with at room temperature (3.16±1,24) at 6 hours, statistically significant (p<0.05). PFAT5 population in refigerator storage procedure was 1,56% and at room temperatur was 5% at 6 hours. No evidence of macroscopic change was noted all of samples (n=12/100%). Conclusion.MDS of propofol 200 mg-lidocaine 10 mg mixture in refrigerator storage procedure was less than at room temperature. The results were consistent in 3 hours and 6 hours.

Latar belakang. Propofol (2,6-diisopropylphenol) telah mendapatkan popularitas sebagai obat anestesi baik untuk induksi maupun pemeliharaan anestesi.Propofol diformulasikan sebagai makroemulsi dengan minyak kedelai (100 mg/ml), lesitin (12 mg/ml), dan gliserol (22,5 mg/ml). Penyuntikan emulsi propofol sering menimbulkan nyeri. Untuk menguranginya biasanya dicampur dengan lidokain berbagai konsentrasi. Makroemulsi propofol ini secara termodinamik tidak stabil dan mengalami degradasi seiring dengan waktu. Pencampuran dengan lidokain akan menurunkan pH emulsi propofol sehingga mempercepat terjadinya degradasi emulsi propofol yang secara fisik ditandai dengan pembesaran ukuran droplet emulsi propofol. Pembesaran ukuran droplet propofol berakibat terhadap penurunan kecepatan pelepasan propofol, penurunan konsentrasi propofol dan risiko terjadinya emboli lemak. Risiko emboli lemak meningkat bila ukuran droplet lebih besar daripada populasi percentage of FAT globule>5 m (PFAT5) yang lebih dari 0,05%. Pada praktek sehari-hari sering dijumpai adanya pencampuran emulsi propofol dengan lidokain guna mengurangi nyeri penyuntikan, yang kemudian disimpan dalam lemari pendingin atau suhu ruanganuntuk penggunaan berikutnya.Tujuan dari penelitian ini adalah untuk mengetahui apakah terjadi perbedaan ukuran rerata droplet emulsi propofol yang dicampur dengan lidokainsetelah prosedur penyimpanan selama 3 dan 6 jam pada suhu yang berbeda.

Metode. Jenis penelitian yang digunakan adalah penelitian eksperimental terencana (control trial) dengan tujuan menilai perbandinganMean Droplet Size (MDS) sesudah prosedur penyimpanan pada suhu lemari pendingin (2-4)0 C dan suhu ruangan (19-24)0 C selama 3 dan 6 jam. Terdapat12 sampel pada masing-masing perlakuan. Ukuran droplet diamati di bawah mikroskop monitor secara manual sebanyak 500 droplet tiap sampel.Analisa dataperbedaan MDS antara penyimpanan dalam suhu yang berbeda, digunakan uji t tidak berpasanganpada data yang berdistribusi normal dan uji Man Whitneyuntuk data yang berdistribusi tidak normal. Nilai p<0,05 secara statistik dianggap bermakna.

Hasil. Tampak adanya perbedaanMDS pada jam ke-3 antara penyimpanan lemari pendingin (1,99±0,45) dengan suhu ruangan (2,18±0,67) yang bermakna secara statistik (p<0.05), dan pada jam ke-6 penyimpanan lemari pendingin (2,84±0,93) dengan suhu ruangan (3,16±1,24) yang bermakana secara statistik (p< 0,05). Nilai PFAT5jam ke-6 penyimpanan lemari pendingin 1,56 % dan suhu ruangan 5 %. Secara makroskopis penampakan fisik warna dan homogenitas propofol dari waktu dan penyimpanan tidak berubah (warna sesuai standar dan homogen) (masing-masing n=12/100%).

Kesimpulan. Rerata ukuran droplet campuran propofol 200 mg dengan lidokain 10 mg setelah prosedur penyimpanan dalam lemari pendingin, lebih kecil dibandingkan dengan penyimpanan suhu ruangan, pada jam ke-3 dan jam ke-6

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