Erişkin Hastalarda Kolonoskop Yerleştirilmesi İçin Propofolün Medyan Etkili Dozunun Tahmini: Prospektif Doz Belirleme Çalışması

Öz

Öz Amaç: Kolonoskopi uygulanan erişkin hastalarda, kolonoskopun rektosigmoid bileşkeden ağrısız ve hareketsiz şekilde ilerletilmesini sağlamak için gereken propofolün medyan etkili dozunu (ED₅₀) tahmin etmek. Yöntemler: Bu prospektif doz belirleme çalışması 12 Eylül 2025 ile 15 Ekim 2025 tarihleri arasında gerçekleştirildi. Elektif kolonoskopi planlanan, 65 yaş altı, ASA I–III ve BMI <30 kg/m² olan erişkin hastalar çalışmaya dahil edildi. İntravenöz bolus propofol, modifiye Dixon up-and-down yöntemi kullanılarak uygulandı; başlangıç dozu 1.5 mg/kg olarak belirlendi ve doz 0.1 mg/kg’lık basamaklarla ayarlandı. İndüksiyondan sonra, ilacın pik etkisini değerlendirmek amacıyla 2 dakikalık gözlem süresi beklendi. Başarı, kolonoskop yerleştirilmesi sırasında ağrı, hareket veya sözel yanıt olmaksızın MOAA/S ≤2 sağlanması olarak tanımlandı; başarılı yanıt durumunda bir sonraki hastada propofol dozu 0.1 mg/kg azaltıldı. Başarısızlık durumunda ise doz 0.1 mg/kg artırıldı. Crossover noktaları, başarılı yanıttan başarısız yanıta veya başarısız yanıttan başarılı yanıta geçişler olarak tanımlandı. Bulgular: Sekiz crossover noktasına ulaşıldıktan sonra çalışma 27. hastada sonlandırıldı. Kolonoskop yerleştirilmesinde başarı için tahmin edilen propofol ED₅₀ değeri 1.026 mg/kg idi (%95 GA, 0.735–1.317 mg/kg). Sonuç: Bu çalışma, seçilmiş erişkin hastalarda kolonoskopun rektosigmoid bileşkeden ağrısız ve hareketsiz geçişi için gerekli propofol dozuna ilişkin ED₅₀ tahmini sağlamaktadır. Bu bulgular, bireyselleştirilmiş başlangıç bolus doz titrasyonuna katkı sağlayabilir ve daha geniş ve çeşitli popülasyonlarda yürütülecek doğrulayıcı çalışmalar için ön veri sunabilir. Anahtar kelimeler: Propofol, sedasyon, medyan etkili doz, kolonoskopi, endoskopi

Anahtar Kelimeler

• Propofol
• sedasyon
• medyan etkili doz
• kolonoskopi
• endoskopi

Destekleyen Kurum

Yok.

Etik Beyan

Çalışma için etik kurul onayı, Helsinki Bildirgesi’ne uygun olarak Kocaeli Üniversitesi Klinik Araştırmalar Etik Kurulu tarafından 15 Mayıs 2025 tarihinde verilmiştir (Etik Kurul No: KAEK/09.bI.03).

Teşekkür

Yok.

Estimation of the Median Effective Dose of Propofol for Colonoscope Insertion in Adult Patients: A Prospective Dose-Finding Study

Öz

Aim: To estimate the median effective dose (ED₅₀) of propofol required to achieve painless and motionless colonoscope advancement through the rectosigmoid junction in adult patients undergoing colonoscopy. Methods: This prospective dose-finding study was conducted from September 12, 2025 to October 15, 2025. Adults aged <65 years, ASA I–III, and BMI <30 kg/m² undergoing elective colonoscopy were included. Intravenous bolus propofol was given using a modified Dixon up-and-down method, starting at 1.5 mg/kg with 0.1 mg/kg stepwise adjustments. After induction, a 2-minute observation allowed peak effect assessment. Success (MOAA/S ≤2 without pain, movement, or verbal response) prompted a 0.1 mg/kg dose decrease for the next patient; failure prompted an increase. Crossovers were defined as changes from success to failure or vice versa. Results: After eight crossover points, the study concluded at the 27th patient. The estimated ED₅₀ of propofol for successful colonoscope insertion was 1.026 mg/kg (95% CI, 0.735–1.317 mg/kg). Conclusion: This study estimated the ED₅₀ of propofol required to achieve painless and motionless passage of the colonoscope through the rectosigmoid junction in selected adult patients. These findings may contribute to individualized initial bolus dose titration and provide preliminary data for future confirmatory studies with larger and more diverse populations. Keywords: Propofol, sedation, median effective dose, colonoscopy, endoscopy

Anahtar Kelimeler

• Propofol
• sedation
• median effective dose
• colonoscopy
• endoscopy

Destekleyen Kurum

None.

Etik Beyan

Ethical approval for the study (Ethics Committee No: KAEK/09.bI.03) was granted on May 15, 2025, by the Kocaeli University Clinical Research Ethics Committee in accordance with the Helsinki Declaration.

Teşekkür

None.

Kaynakça

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