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

Yıl 2005, Cilt: 4 Sayı: 2, 100 - 105, 01.08.2005

Dilek Oğuz Aydın Şeref Köksal Bahattin Çiçek Erkan Parlak Burhan Şahin

Öz

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 pancreasbiliary 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.

Anahtar Kelimeler

Endoscopic ultrasonography, sedation, midazolam

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

Öz

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). Grupları n 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 pankreas-biliyer sistem için yapılan endosonografi işlemlerinin sedasyon uygulanmadan da gerçekleştirilebileceğini düşünmekteyiz.

Anahtar Kelimeler

Endoskopik ultrasonografi, sedasyon, midazolam

Kaynakça

• Daneshmend TK, Bell GD, Logan RFA. Sedation for upper gastro- intestinal endoscopy: results of a nationwide survey. Gut 1991; 32: 12-15.
• Keefe EB, O’Connor KW. 1989 ASGE survey of endoscopic sedation and monitoring practices. Gastrointest Endosc 1990; 36: S13-S18.
• Nagengast EM. Sedation and monitoring in gastrointestinal endos- copy. Scand J Gastroenterol 1993; 200: 28-32.
• Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinical re- levant complications and monitoring of endoscopy: results of a na- tionwide survey in Switzerland. Endoscopy 1994; 26: 231-234.
• Bonta PI, Kok MF, Bergman JJGH, et al. Conscious sedation for EUS of the esophagus and stomach: a double-blind, randomized, controlled trial comparing midazolam with placebo. Gastrointest Endosc 2003; 57: 842-847.
• Hoare AM, Hawkins CF. Upper gastrointestinal endoscopy with and without sedation: Patient’s opinions. Br Med J 1976; 2: 20.
• Al-Atrakchi HA. Upper gastrointestinal endoscopy without sedati- on: a prospective study of 2000 examinations. Gastrointest Endosc 1989; 35: 79-81.
• Pereira S, Hussaini SH, Hanson PJ, et al. Endoscopy: Throat spray or sedation? R Coll Physicians Lond 1994; 28: 411-414.
• Lieberman DA, Wuerker CK, Katon RM. Cardiopulmonary risk of esophagogastroduodenoscopy. Gastroenterology 1985; 88: 468-472.
• Froehlich F, Schwizer W, Thorens J, et al. Conscious sedation for gastroscopy: Patient tolerance and cardiorespiratory parameters. Gastroenterology 1995; 108: 697-704.
• Waye JD. Perspectives: Worldwide use of sedation and analgesia for upper intestinal endoscopy. Gastrointest Endosc 1999; 50: 888-891.
• Ristikankare KO, Julkunen RJK. Premedication for gastrointestinal endoscopy is a rare practice in Finland: a nationwide survey. Gast- rointest Endosc 1988; 47: 204-7.
• Woloshynowich M, Oakley DA, Saunders BP, et al. Psychological aspects of gastrointestinal endoscopy: a review. Endoscopy 1996; 28: 763-767.
• Drossman DA, Brandt LJ, Sears C. A preliminary study of patients’ concerns related to GI endoscopy. Am J Gastroenterol 1996; 91: 287-291.
• Martin JP, Arlett PA, Holdstock G. Development of a sedation po- licy for upper GI endoscopy based on an audit of patients’ percep- tion of procedure. Eur J Gastroenterol Hepatol 1996; 8: 355-357.
• Abraham N, Barjun A, Larocque M, et al. Predicting which patients can undergo uper endoscopy comfortably without conscious sedati- on. Gastrointest Endosc 2002; 56: 180-189.
• Kankaria A, Lewis JH, Ginsberg G, et al. Flumazenil reversal of psychomotor impairment due to midazolam or diazepam for consci- ous sedation for upper endoscopy. Gastrointest Endosc 1996; 44: 416-412.
• Arrowsmith JB, Gerstman BB, Fleischer DE, et al. Results from the American Society for Gastrointestinal Endoscopy/US Food and Drug Administration colloborative study on complication rates and drug use during gastrointestinal endoscopy. Gastrointest Endosc 1991; 37: 421-427.
• McCloy RF, Pearson RC. Which agent and how to deliver it? A re- view of benzodiazepine and its reversal in endoscopy. Scand J Gast- roenterol 1990; 25 (Suppl 179): 7-11.
• FDA’s Regulation of the new drug Versed. Hearing before a sub- committee of the Committee on Government operations, House of Representatives, May 5 and 10, US Government Printing Office, Washington DC, 1988.
• Rizzo J, Bernstein D, Gress F, et al. A randomized double-blind pla- cebo-controlled trial evaluating the cost-effectiveness of droperidol as a sedative medication for EUS. Gastrointest Endosc 1999; 50: 178-182.
• Allescher HD, Rösch T, Willkomm G, et al. Performance patient ac- ceptance appropriateness of indications and potential influence on outcome of EUS; a prospective study in 397 consecutive patients. Gastrointest Endosc 1999; 50: 737-745.