Dilek OĞUZ, Aydın Şeref KÖKSAL, Bahattin ÇİÇEK, Erkan PARLAK, Burhan ŞAHİN

Tanısal amaçlı endoskopik ultrasonografi yapılan hastalarda bilinçli sedasyon: Midazolam ile plaseboyu karşılaştıan randomize, çift kör, kontrollü çalışma

Giriş ve amaç: Endoskopik işlemlerde bilinçli sedasyon uygulanması konusunda henüz bir görüş birliğine varılamamıştır. Bu prospektif çalışmada tanısal endoskopik ultrasonografi yapılan hastalarda sedasyon gereksinimini belirlemeyi amaçladık. Gereç ve yöntem: Çalışmaya Türkiye Yüksek İhtisas Hastanesi Gastroenteroloji Kliniği'nde tanısal endoskopik ultrasonografi yapılan 80 hasta alındı. Hastalar incelenen bölgelere göre özofagus (11 hasta), mide-duodenum (16 hasta) ve pankreatobiliyer sistem (49 hasta) olmak üzere üç gruba ayrıldı. Gruplar midazolam (42 hasta) veya plasebo (34 hasta) almak üzere çift kör randomize edildiler. Midazolam ve serum fizyolojik intravenöz yoldan 0.07mg/kg ve 0.07 ml/kg dozlarında verildi. Hastaların eğitim süreleri, daha önce endoskopi yaptırıp yaptırmadıkları, anksiyete skoru, nabız ve oksijen satürasyonu, sedasyon skoru, hasta ve endoskopist tarafından belirlenen işlem zorluğu, hasta kooperasyonu, işlemi tekrar yaptırma eğilimi, ağrı düzeyi, endoskopu yutma ve toplam işlem süresi ile oksijenasyon ve kalp ritmindeki değişiklikleri karşılaştırıldı. Bulgular: Her üç grupta plasebo ve midazolam alan hastaların ortalama anksiyete skorları, eğitim süreleri, bazal nabız ve oksijen satürasyonları ile önceden endoskopi yaptırma oranları benzerdi. Sedasyon skoru midazolam alan hastalarda plasebo grubuna göre daha yüksek olup aradaki fark üçüncü grupta istatistiksel anlamlılık boyutuna ulaşıyordu (p=0.03). İşlem zorluğu, hasta kooperasyonu ve hastanın işlemi tekrar yaptırma eğilimi her üç grupta da midazolam lehine idi. Hipoksi ve oksijen ihtiyacı üçüncü grupta midazolam verilen hastalarda istatistiksel olarak anlamlı düzeyde daha fazla idi (p=0.04). Grupların ağrı düzeyi, endoskopu yutma ve toplam işlem süreleri arasında anlamlı farklılık bulunmadı. Sonuç: Plasebo ve midazolam alan hastalar arasındaki farklılıkların anlamlı olmamasına dayanarak özofagus, mide ve pankreasbiliyer sistem için yapılan endosonografi işlemlerinin sedasyon uygulanmadari'da gerçekleştirilebileceğini düşünmekteyiz.

Anahtar Kelimeler:

Plasebo, Endosonografi, İleriye dönük çalışma, Bilinçli sedasyon, Midazolam

Conscious sedation during diagnostic endoscopic ultrasonography: A randomized, double-blind, comtrolled trial comparing midazolam with placebo

Background/aim: There is no consensus regarding the application of conscious sedation in endoscopic procedures. In this prospective study we aimed to determine the necessity of applying sedation in diagnostic endoscopic ultrasonography. Materials and methods: Eighty patients who underwent endoscopic ultrasonography in Türkiye Yüksek İhtisas Hospital Gastroenterology Clinic were included in the study. Patients were separated into three groups depending on the region examined: esophagus (11 patients), stomach-duodenum (16 patients), and pancreas-biliary system (49 patients). Groups were randomized to receive either midazolam (42 patients) or placebo (34 patients) in a double-blind fashion. Midazolam and isotonic saline were administered intravenously at doses of 0.07 mg/kg and 0.07 ml/kg, respectively. The education period, previous endoscopy history, anxiety score, basal pulse and oxygen saturation, sedation score, and difficulty of procedure were determined separately by endoscopist. The patient, cooperation of the patient, willingness to undergo the same procedure again, pain level, intubation time, total procedure time, and the changes in the oxygenation and cardiac rhythm were compared. Results: The mean anxiety score, education period, basal pulse and oxygen saturation, and the ratio of a previous endoscopy history of the patients receiving midazolam and placebo were similar in all three groups. Sedation score was higher in patients receiving midazolam compared to those receiving isotonic saline, and the difference was statistically significant in the third group (p=0.03). Difficulty of the procedure, cooperation of the patient and willingness of the patient to undergo the same procedure again were in favor of midazolam in all three groups. Hypoxia and the need for oxygen were significantly higher in the third group of patients receiving midazolam (p=0.04). There was no significant difference between the pain level, intubation time, and total procedure time of the groups. Conclusion: Based on the insignificant differences between the patients receiving placebo and midazolam, we think that endosonography of the esophagus, stomach, and pancreas-biliary system can be performed without sedation.

Keywords:

Placebos, Endosonography, Prospective Studies, Conscious Sedation, Midazolam,

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